Patient Examination Gowns and Capes Suppliers
Limit companies to: Worldwide USA
Dalian Goodwood Medical Care Ltd | Address: 3-91 Jiulicun Yongzheng Street, Jinzhou District, Dalian 116100, China 
www.dl-goodwood.com | Send Inquiry | Phone: +86-(411)-87857277
FDA Registration: 3007517215
Products: Tongue Depressors (FDA Code: FMA), Patient Examination Gowns and Capes (FDA Code: FME), Infant Tongue Depressor (FDA Code: FMA), Adult Tongue Depressor (FDA Code: FMA), Junior Tongue Depressor (FDA Code: FMA), Examination Gown (FDA Code: FME), ...
Dalian Goodwood Medical Care Ltd manufactures and supplies disposal products. Our products include tongue depressors, cervical scrapers, cotton swabs, sponge swabs, cervix brush and cytology brush, pr more...
www.dl-goodwood.com | Send Inquiry | Phone: +86-(411)-87857277
FDA Registration: 3007517215
Products: Tongue Depressors (FDA Code: FMA), Patient Examination Gowns and Capes (FDA Code: FME), Infant Tongue Depressor (FDA Code: FMA), Adult Tongue Depressor (FDA Code: FMA), Junior Tongue Depressor (FDA Code: FMA), Examination Gown (FDA Code: FME), ...
Dalian Goodwood Medical Care Ltd manufactures and supplies disposal products. Our products include tongue depressors, cervical scrapers, cotton swabs, sponge swabs, cervix brush and cytology brush, pr more...
Guangzhou Prosperity Enterprise, Ltd. | Address: 206 Huanshidong Rd.,Jiangpu, Conghua, Guangzhou, Guangzhou 510925, China
Phone: +86-(20)-879-81061
Products: Patient Examination Gowns and Capes (FDA Code: FME), Examination Gown (FDA Code: FME), Surgical Caps (FDA Code: FYF), Conductive Shoe and Shoe Cover (FDA Code: BWP), ...
Guangzhou Prosperity Enterprise, Ltd. is engaged in the production of conductive shoes and shoe covers, examination gowns, patient examination gowns & caps, and surgical caps. more...
Phone: +86-(20)-879-81061
Products: Patient Examination Gowns and Capes (FDA Code: FME), Examination Gown (FDA Code: FME), Surgical Caps (FDA Code: FYF), Conductive Shoe and Shoe Cover (FDA Code: BWP), ...
Guangzhou Prosperity Enterprise, Ltd. is engaged in the production of conductive shoes and shoe covers, examination gowns, patient examination gowns & caps, and surgical caps. more...
Jiangsu Guangda Medical Material Co., Ltd. | Address: 18 Baochang Road North, Libao town, Haian 226631, China
www.js.cei.gov.cn | Send Inquiry | Phone: +86-(513)-88219001
FDA Registration: 3006847952 Quality: ISO 9001:2000, ISO 13485:2003, CE Mark Certified
Products: Surgical Drapes & Packs (FDA Code: KKX), Adhesive Bandages (FDA Code: KGX), Elastic Bandages (FDA Code: FQM), Surgical Drapes (FDA Code: KKX), Patient Examination Gowns and Capes (FDA Code: FME), Tonsil Dissector (FDA Code: KBM), ...
Jiangsu Guangda Medical Material Co., Ltd. is a manufacturer and exporter of medical products. Our product line includes surgical towels, lap sponges, gauze sponges, gauze bandage, gauze roll masks, c more...
www.js.cei.gov.cn | Send Inquiry | Phone: +86-(513)-88219001
FDA Registration: 3006847952 Quality: ISO 9001:2000, ISO 13485:2003, CE Mark Certified
Products: Surgical Drapes & Packs (FDA Code: KKX), Adhesive Bandages (FDA Code: KGX), Elastic Bandages (FDA Code: FQM), Surgical Drapes (FDA Code: KKX), Patient Examination Gowns and Capes (FDA Code: FME), Tonsil Dissector (FDA Code: KBM), ...
Jiangsu Guangda Medical Material Co., Ltd. is a manufacturer and exporter of medical products. Our product line includes surgical towels, lap sponges, gauze sponges, gauze bandage, gauze roll masks, c more...
Hubei Huanfu Plastic Products Co., Ltd | Address: No. 188 Wanfu Street, Chenhu Town, Hanchuan City 431608, China
www.hfnonwoven.com | Phone: +86-(712)-8742168
FDA Registration: 3004105221 Quality: ISO 9001:2000 Certified
Products: Surgical Gloves, Disposable Gloves, Latex Gloves, Surgical Face Masks, Patient Examination Gowns and Capes (FDA Code: FME), Isolation Gowns, ...
Hubei Huanfu Plastic Products Co., Ltd produces non-wovens, surgical masks, surgical gowns, coverall, isolation gowns, caps, doctor caps, nurse caps and bouffant caps. We provide PP nonwoven, Spunbond more...
www.hfnonwoven.com | Phone: +86-(712)-8742168
FDA Registration: 3004105221 Quality: ISO 9001:2000 Certified
Products: Surgical Gloves, Disposable Gloves, Latex Gloves, Surgical Face Masks, Patient Examination Gowns and Capes (FDA Code: FME), Isolation Gowns, ...
Hubei Huanfu Plastic Products Co., Ltd produces non-wovens, surgical masks, surgical gowns, coverall, isolation gowns, caps, doctor caps, nurse caps and bouffant caps. We provide PP nonwoven, Spunbond more...
Hubei Wanhu Plastic Plant | Address: 105 Chenhu Rd., Hanchuan Hubei, China
Phone: +86-(712)-8740198
Products: Patient Examination Gowns & Capes, Surgical Caps, New Or Used Disposable Examination Gowns and Capes, Patient Examination Gowns and Capes (FDA Code: FME), Protective Surgical Cap, Examination Gown (FDA Code: FME), ...
Hubei Wanhu Plastic Plant provides examination gown, operating room shoe cover, protective surgical cap and surgical isolation gown. more...
Phone: +86-(712)-8740198
Products: Patient Examination Gowns & Capes, Surgical Caps, New Or Used Disposable Examination Gowns and Capes, Patient Examination Gowns and Capes (FDA Code: FME), Protective Surgical Cap, Examination Gown (FDA Code: FME), ...
Hubei Wanhu Plastic Plant provides examination gown, operating room shoe cover, protective surgical cap and surgical isolation gown. more...
Zhejiang Medicines & Health Products Import & Expo | Address: 101/2 North Zhongshan Rd., Zmc Bldg., Hangzhou 310003, China
Phone: +86-(571)-87036338
FDA Registration: 9680222
Products: Urine Collection Leg Bags (FDA Code: FAQ), Surgical Drapes & Packs (FDA Code: KKX), Surgical Drapes (FDA Code: KKX), Patient Examination Gowns and Capes (FDA Code: FME), Surgical Trays (FDA Code: LRP), Sterile Leg Urine Collection Bag for External Use (FDA Code: FAQ), ...
Zhejiang Medicines & Health Products Import & Expo offers isolation gown and vaginal speculum. more...
Phone: +86-(571)-87036338
FDA Registration: 9680222
Products: Urine Collection Leg Bags (FDA Code: FAQ), Surgical Drapes & Packs (FDA Code: KKX), Surgical Drapes (FDA Code: KKX), Patient Examination Gowns and Capes (FDA Code: FME), Surgical Trays (FDA Code: LRP), Sterile Leg Urine Collection Bag for External Use (FDA Code: FAQ), ...
Zhejiang Medicines & Health Products Import & Expo offers isolation gown and vaginal speculum. more...
Hangzhou Jincheng Medical Supplies Manufacture Co,Ltd. | Address: 202 Zhangshan Road, Renhe Town, Yuhang District, Hangzhou 311107, China
www.jincheng.biz | Send Inquiry | Phone: +86-(571)-86396888
FDA Registration: 3003561450 Quality: ISO 13485 and CE Certified
Products: Patient Examination Gowns and Capes (FDA Code: FME), Surgical Gowns (FDA Code: FYA), Examination Gown (FDA Code: FME), Surgical Caps (FDA Code: FYF), Conductive Shoe and Shoe Cover (FDA Code: BWP), Operating Room Shoe Cover (FDA Code: FXP), ...
Hangzhou Jincheng Medical Supplies Manufacture Co,Ltd. specializes in surgical gowns, drapes, antimicrobial products, protective series and incontinence products. We develop a full-line of medical and more...
www.jincheng.biz | Send Inquiry | Phone: +86-(571)-86396888
FDA Registration: 3003561450 Quality: ISO 13485 and CE Certified
Products: Patient Examination Gowns and Capes (FDA Code: FME), Surgical Gowns (FDA Code: FYA), Examination Gown (FDA Code: FME), Surgical Caps (FDA Code: FYF), Conductive Shoe and Shoe Cover (FDA Code: BWP), Operating Room Shoe Cover (FDA Code: FXP), ...
Hangzhou Jincheng Medical Supplies Manufacture Co,Ltd. specializes in surgical gowns, drapes, antimicrobial products, protective series and incontinence products. We develop a full-line of medical and more...
Hangzhou A-Tek Medical & Textiles Co., Ltd. | Address: NO.598 ZHONGSHAN BEI RD, HANGZHOU, Hangzhou Zhejiang 310006, China
Phone: +86-(571)-88121631
FDA Registration: 9615944
Products: Patient Examination Gowns and Capes (FDA Code: FME), Examination Gown (FDA Code: FME), Surgical Caps (FDA Code: FYF), Collecting Vessel Gas (FDA Code: KGK), Conductive Shoe and Shoe Cover (FDA Code: BWP), Operating Room Shoe Cover (FDA Code: FXP), ...
Hangzhou A-Tek Medical & Textiles Co., Ltd. manufactures woven, non-woven underpads and apparels for the healthcare industries & hospitals. We supply disposable & reusable underpads, bibs, disposable more...
Phone: +86-(571)-88121631
FDA Registration: 9615944
Products: Patient Examination Gowns and Capes (FDA Code: FME), Examination Gown (FDA Code: FME), Surgical Caps (FDA Code: FYF), Collecting Vessel Gas (FDA Code: KGK), Conductive Shoe and Shoe Cover (FDA Code: BWP), Operating Room Shoe Cover (FDA Code: FXP), ...
Hangzhou A-Tek Medical & Textiles Co., Ltd. manufactures woven, non-woven underpads and apparels for the healthcare industries & hospitals. We supply disposable & reusable underpads, bibs, disposable more...
Sino Protection (hefei) Non-Woven Products Co., Lt | Address: Area B, New Station Industrial Park, Hefei City, China
Phone: +852-(231)-41300
FDA Registration: 3004362278 Quality: ISO9002 Certified
Products: Surgical Drapes & Packs (FDA Code: KKX), Surgical Drapes (FDA Code: KKX), Patient Examination Gowns and Capes (FDA Code: FME), Surgical Gowns (FDA Code: FYA), Arm Slings (FDA Code: ILI), Ice Bags (FDA Code: KYR), ...
Sino Protection (hefei) Non-Woven Products Co., Lt manufactures,exports and imports spunlace nonwoven fabric. We use the water-jet technology of rieter-perfject, France. We produce nonwoven rolls 3500 more...
Phone: +852-(231)-41300
FDA Registration: 3004362278 Quality: ISO9002 Certified
Products: Surgical Drapes & Packs (FDA Code: KKX), Surgical Drapes (FDA Code: KKX), Patient Examination Gowns and Capes (FDA Code: FME), Surgical Gowns (FDA Code: FYA), Arm Slings (FDA Code: ILI), Ice Bags (FDA Code: KYR), ...
Sino Protection (hefei) Non-Woven Products Co., Lt manufactures,exports and imports spunlace nonwoven fabric. We use the water-jet technology of rieter-perfject, France. We produce nonwoven rolls 3500 more...
Xiantao Fushi Protective Products Co., Ltd. | Address: No. 89 Pengchang Ave., Xiantao City, Hubei 433018, China
www.hb-nonwoven.com | Send Inquiry | Phone: +86-(27)-8784-4646
Products: Face Masks, Headwear, Aprons, Patient Examination Gowns and Capes (FDA Code: FME), Absorbent Disposable Underpads, Isolation Gowns, ...
Xiantao Fushi Protective Products Co., Ltd. specializes in the production of disposable non-woven products. Our products include face masks, head wears, protective apparels, plastic disposables and me more...
www.hb-nonwoven.com | Send Inquiry | Phone: +86-(27)-8784-4646
Products: Face Masks, Headwear, Aprons, Patient Examination Gowns and Capes (FDA Code: FME), Absorbent Disposable Underpads, Isolation Gowns, ...
Xiantao Fushi Protective Products Co., Ltd. specializes in the production of disposable non-woven products. Our products include face masks, head wears, protective apparels, plastic disposables and me more...
GRI Medical & Electronic Technology Co., Ltd. | Address: 1805 Honggao Road, Xiuzhou Industry Zone, Jiaxing 314031, China
Phone: +86-(135)-11359722
FDA Registration: 3004911384
Products: Surgical Drapes & Packs (FDA Code: KKX), Surgical Drapes (FDA Code: KKX), Patient Examination Gowns and Capes (FDA Code: FME), Surgical Trays (FDA Code: LRP), Surgical Gowns (FDA Code: FYA), Adjustable Hospital AC-Powered Beds (FDA Code: FNL), ...
GRI Medical & Electronic Technology Co., Ltd. offers surgical & medical equipments like disposable medical beds, blood collection lancet, surgical trays, ophthalmic patient drape and external brace kn more...
Phone: +86-(135)-11359722
FDA Registration: 3004911384
Products: Surgical Drapes & Packs (FDA Code: KKX), Surgical Drapes (FDA Code: KKX), Patient Examination Gowns and Capes (FDA Code: FME), Surgical Trays (FDA Code: LRP), Surgical Gowns (FDA Code: FYA), Adjustable Hospital AC-Powered Beds (FDA Code: FNL), ...
GRI Medical & Electronic Technology Co., Ltd. offers surgical & medical equipments like disposable medical beds, blood collection lancet, surgical trays, ophthalmic patient drape and external brace kn more...
Jingmen Huasheng Sanitary Products Co Ltd | Address: No. 1 Bailongguan, Quijialing District, Jingmen 431821, China
Phone: +86-(574)-87907746
Products: Patient Examination Gowns & Capes, Patient Examination Gowns and Capes (FDA Code: FME), Surgical Suite, Examination Gown (FDA Code: FME), Disposable/Reusable Surgical Suit (FDA Code: FXO), Surgical Disposable Scrub Suit, ...
Jingmen Huasheng Sanitary Products Co Ltd manufactures sanitary products for medical field. Our products include examination gowns, disposable & reusable surgical suits, non surgical isolation gowns & more...
Phone: +86-(574)-87907746
Products: Patient Examination Gowns & Capes, Patient Examination Gowns and Capes (FDA Code: FME), Surgical Suite, Examination Gown (FDA Code: FME), Disposable/Reusable Surgical Suit (FDA Code: FXO), Surgical Disposable Scrub Suit, ...
Jingmen Huasheng Sanitary Products Co Ltd manufactures sanitary products for medical field. Our products include examination gowns, disposable & reusable surgical suits, non surgical isolation gowns & more...
Epard Protective Products, Ltd. | Address: No. 1, Bailongguan, Qujialing District, Jinshang 431821, China
Phone: +86-(574)-87907746
Products: Patient Examination Gowns and Capes (FDA Code: FME), Examination Gown (FDA Code: FME), Disposable/Reusable Surgical Suit (FDA Code: FXO), Surgical Apparel Accessories (FDA Code: LYU), Non-Surgical Isolation Gown (FDA Code: OEA), ...
Epard Protective Products, Ltd. manufactures surgical accessories. We provide patient examination gowns and caps, non-surgical isolation gowns, examination gowns and disposable/reusable surgical suits more...
Phone: +86-(574)-87907746
Products: Patient Examination Gowns and Capes (FDA Code: FME), Examination Gown (FDA Code: FME), Disposable/Reusable Surgical Suit (FDA Code: FXO), Surgical Apparel Accessories (FDA Code: LYU), Non-Surgical Isolation Gown (FDA Code: OEA), ...
Epard Protective Products, Ltd. manufactures surgical accessories. We provide patient examination gowns and caps, non-surgical isolation gowns, examination gowns and disposable/reusable surgical suits more...
Sanxin Medical Devices Group | Address: No.999 Fushan Road, Xiaolan Industry, Park, Nanchang Jiangxi China., Nanchang 330200, China
www.sanxin-med.cn | Phone: +86-(791)-5988819
FDA Registration: 3005246939
Products: Oxygen Masks (FDA Code: BYG), Disposable Syringes, Catheter Accessories (FDA Code: KGZ), Venous Catheter, Infusion Catheter (FDA Code: JCY), Adhesive Bandages (FDA Code: KGX), ...
Sanxin Medical Devices Group manufactures a series of disposable syringes, I.V. sets, catheters & tubes, hemodialysis and vaginal supplies. Our products include sterile syringes, infusion sets, hypode more...
www.sanxin-med.cn | Phone: +86-(791)-5988819
FDA Registration: 3005246939
Products: Oxygen Masks (FDA Code: BYG), Disposable Syringes, Catheter Accessories (FDA Code: KGZ), Venous Catheter, Infusion Catheter (FDA Code: JCY), Adhesive Bandages (FDA Code: KGX), ...
Sanxin Medical Devices Group manufactures a series of disposable syringes, I.V. sets, catheters & tubes, hemodialysis and vaginal supplies. Our products include sterile syringes, infusion sets, hypode more...
Jiemei International Corporation | Address: 28c, 2 South Taiping Road, Nanjing 210002, China
Phone: +86-(25)-7911175
Products: Patient Examination Gowns and Capes (FDA Code: FME), Examination Gown (FDA Code: FME), Surgical Caps (FDA Code: FYF), Surgical Apparel Accessories (FDA Code: LYU), Non-Surgical Isolation Gown (FDA Code: OEA), ...
Jiemei International Corporation offers surgical caps, patient examination gowns and capes. We also use non-surgical isolation gowns, surgical apparel accessories and examination gowns. more...
Phone: +86-(25)-7911175
Products: Patient Examination Gowns and Capes (FDA Code: FME), Examination Gown (FDA Code: FME), Surgical Caps (FDA Code: FYF), Surgical Apparel Accessories (FDA Code: LYU), Non-Surgical Isolation Gown (FDA Code: OEA), ...
Jiemei International Corporation offers surgical caps, patient examination gowns and capes. We also use non-surgical isolation gowns, surgical apparel accessories and examination gowns. more...
Ningbo Evergrand Medical Ltd | Address: 31 Yaohang Steet,Ningbo,China, Ningbo 315010, China
www.evergrandonline.com | Send Inquiry | Phone: +86-(574)-27882323
FDA Registration: 3006210673 Quality: CE Mark Certified
Products: Oxygen Masks (FDA Code: BYG), Forceps (FDA Code: HTD), Urine Collection Leg Bags (FDA Code: FAQ), Tongue Depressors (FDA Code: FMA), Adhesive Bandages (FDA Code: KGX), Patient Examination Gowns and Capes (FDA Code: FME), ...
Ningbo Evergrand Medical Ltd manufactures and exports disposable medical products and healthy products. Our products include underpads, dental bibs, syringes, bandages, first aid products, surgical dr more...
www.evergrandonline.com | Send Inquiry | Phone: +86-(574)-27882323
FDA Registration: 3006210673 Quality: CE Mark Certified
Products: Oxygen Masks (FDA Code: BYG), Forceps (FDA Code: HTD), Urine Collection Leg Bags (FDA Code: FAQ), Tongue Depressors (FDA Code: FMA), Adhesive Bandages (FDA Code: KGX), Patient Examination Gowns and Capes (FDA Code: FME), ...
Ningbo Evergrand Medical Ltd manufactures and exports disposable medical products and healthy products. Our products include underpads, dental bibs, syringes, bandages, first aid products, surgical dr more...
Guangzhou Fortunique Ltd. | Address: Block B 2, Zhou Shan Gang, Shi Bei Industrial Ave, Pan Yu Dist., Guangzhou 511410, China
FDA Registration: 3003915904
Products: Patient Examination Gowns and Capes (FDA Code: FME), Arm Slings (FDA Code: ILI), Ice Bags (FDA Code: KYR), Bone Clamp (FDA Code: HXD), Traction Accessories, Leg Straps (FDA Code: ILZ), Examination Gown (FDA Code: FME), ...
Guangzhou Fortunique Ltd. is a contract manufacturer of surgical and medical products. Our product line consists of arm slings, corrective shoe orthosis, disposable medical beds, surgical cameras, han more...
FDA Registration: 3003915904
Products: Patient Examination Gowns and Capes (FDA Code: FME), Arm Slings (FDA Code: ILI), Ice Bags (FDA Code: KYR), Bone Clamp (FDA Code: HXD), Traction Accessories, Leg Straps (FDA Code: ILZ), Examination Gown (FDA Code: FME), ...
Guangzhou Fortunique Ltd. is a contract manufacturer of surgical and medical products. Our product line consists of arm slings, corrective shoe orthosis, disposable medical beds, surgical cameras, han more...
Ying Xing Garment Factory | Address: Ten Tang Wei Industry Zone, Ten Tang Wei, Phon Gang Zhen, Dong Guang, China
Phone: +86-(769)-815-3224981
Products: Patient Examination Gowns and Capes (FDA Code: FME), Examination Gown (FDA Code: FME), Disposable/Reusable Surgical Suit (FDA Code: FXO), Surgical Dress (FDA Code: FYE), Surgical Caps (FDA Code: FYF), Operating Room Shoe Cover (FDA Code: FXP), ...
Ying Xing Garment Factory offers lab coats, bouffant caps, scrub suits, shoe covers, surgeon caps and isolation gowns. more...
Phone: +86-(769)-815-3224981
Products: Patient Examination Gowns and Capes (FDA Code: FME), Examination Gown (FDA Code: FME), Disposable/Reusable Surgical Suit (FDA Code: FXO), Surgical Dress (FDA Code: FYE), Surgical Caps (FDA Code: FYF), Operating Room Shoe Cover (FDA Code: FXP), ...
Ying Xing Garment Factory offers lab coats, bouffant caps, scrub suits, shoe covers, surgeon caps and isolation gowns. more...
World-Top Household Products Co., Ltd. | Address: No. 500 Dongsheng Rd, Heqing, Industrial Rd, Pudong, Shanghai 201201, China
www.worldtop.com.cn | Send Inquiry | Phone: +86-(21)-68919795
Products: Patient Examination Gowns and Capes (FDA Code: FME), Bed Mattresses, Arm Slings (FDA Code: ILI), Viscoelastic system, Examination Gown (FDA Code: FME), Pillow, ...
World-Top Household Products Co., Ltd. manufactures viscose-elastic foam products. Our products include memory foam pillows, mattresses, folding chairs, memory foam gel pillow wooden-floor underlays, more...
www.worldtop.com.cn | Send Inquiry | Phone: +86-(21)-68919795
Products: Patient Examination Gowns and Capes (FDA Code: FME), Bed Mattresses, Arm Slings (FDA Code: ILI), Viscoelastic system, Examination Gown (FDA Code: FME), Pillow, ...
World-Top Household Products Co., Ltd. manufactures viscose-elastic foam products. Our products include memory foam pillows, mattresses, folding chairs, memory foam gel pillow wooden-floor underlays, more...
Shanghai Neo-Medical Import & Export Co., Ltd. | Address: 16/B Oujiang B/D, Zhaojiabang Road, Shanghai 200030, China
Phone: +86-(21)-546-52962
FDA Registration: 3005327291
Products: Gastroenterologic Needle Holder (FDA Code: FHQ), Urine Collection Leg Bags (FDA Code: FAQ), Tongue Depressors (FDA Code: FMA), Catheter Accessories (FDA Code: KGZ), Infusion Catheter (FDA Code: JCY), Adhesive Bandages (FDA Code: KGX), ...
Shanghai Neo-Medical Import & Export Co., Ltd. offers adhesive bandages, cannula clamps, electrocardiograph electrodes, infusion catheters, tongue depressors and surgical trays. more...
Phone: +86-(21)-546-52962
FDA Registration: 3005327291
Products: Gastroenterologic Needle Holder (FDA Code: FHQ), Urine Collection Leg Bags (FDA Code: FAQ), Tongue Depressors (FDA Code: FMA), Catheter Accessories (FDA Code: KGZ), Infusion Catheter (FDA Code: JCY), Adhesive Bandages (FDA Code: KGX), ...
Shanghai Neo-Medical Import & Export Co., Ltd. offers adhesive bandages, cannula clamps, electrocardiograph electrodes, infusion catheters, tongue depressors and surgical trays. more...
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FDA Code / Regulation: FME / 880.6265
An examination gown is a device intended for medical purposes that is made of cloth, paper, or other material that is draped over or worn by a patient as a body covering during a medical examination.
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in 880.9. If the device is not labeled or otherwise represented as sterile, it is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of 820.180, with respect to general requirements concerning records, and 820.198, with respect to complaint files.
