VR

VR Thumb Loop Gown w/Perf., X-Large 4 Mil Trans Blue- Case 50 Count

Registry build 21.09.26
318manufacturers in China registered for this device type
33catalogue numbers in this listing

Who Else Makes It

Concentrated in Hubei (71), Jiangsu (59), Zhejiang (42). 83 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code OEA
Manufacturer City Province Registered as Device types
Hangzhou Rollmed Co., Ltd. Hangzhou Zhejiang Contract manufacturer 127
Zogear Medical Co., Ltd. Yizheng Jiangsu Contract manufacturer 75
GRI Medical & Electronic Technology Co., Ltd. Jiaxing Zhejiang Contract manufacturer 71
Shanghai Joy Crown Industry Co., Ltd. Pu Dong New Area Shanghai Contract manufacturer 64
Anqing Kangmingna Packaging Co., Ltd. Anqing Anhui Contract manufacturer 39
BH Medical Products Co., Ltd. Changzhou Jiangsu Contract manufacturer 37
Taizhou Xinkang Medical Materials Co., Ltd. Taizhou Jiangsu Contract manufacturer 35
Jiangsu Guangda Medical Material Group Co., Ltd. Haian Jiangsu Contract manufacturer 32
Evereast Medical Products Group Co., Ltd. Changyuan Henan Contract manufacturer 30
Ningbo Luke Medical Devices Co., Ltd. Yuyao Zhejiang Contract manufacturer 27
Zhongshan Chukuang Textile Co., Ltd. Zhongshan Guangdong Contract manufacturer 26
Jingmen Huasheng Asia Dynamics Sanitary Products Co., Ltd. Jingmen Hubei Contract manufacturer 23

Showing 12 of 318. All 318 manufacturers in China registered for Non-Surgical Gown

Record

Regulatory record for VR
Listed by Polyconversions, Inc., United States
FDA product code OEA
Device type Non-Surgical Gown
Device class Class 1
Regulation 21 CFR 878.4040
Establishment Manufacturer
Premarket notification Exempt
Record published 2020-09-24
Record revised 2026-04-14 (version 2)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Single use Yes
Label carries lot or batch number, manufacturing date

Catalogue Numbers

Catalogue numbers for VR
Catalogue number Size Status
42680 In distribution
42550 In distribution
42480 In distribution
42680 In distribution
42450 In distribution
42600 In distribution
42510 In distribution
42406 In distribution
42700 In distribution
42470 In distribution
42580 In distribution
42506 In distribution
42506 In distribution
42400 In distribution
42750 In distribution
42610 In distribution
42700 In distribution
42470 In distribution
42450 In distribution
42550 In distribution
42480 In distribution
42750 In distribution
42570 In distribution
42650 In distribution
42580 In distribution
42500 In distribution
42500 In distribution
42650 In distribution
42410 In distribution
42600 In distribution
42570 In distribution
42406 In distribution
42400 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Cardinal Health Cardinal Health 200, LLC 230
Henry Schein Henry Schein, Inc. 144
Darby Dental Supply, LLC Darby Dental Supply, LLC 118
Medline Medline Industries, Inc. 99
Precaution/Isolation Gown Standard Textile Co., Inc. 83
PremierPro Prestige Ameritech 74
Alleset GRI Medical & Electronic Technology Co., Ltd. 71
Medicom Safewear AMD Medicom Inc. 70
Maytex Maytex Corp. 67
Precept® Precept Medical Products, Inc. 61
3D Dental-Essentials 3D Dental Designs AND Development, LLC 56
Halyard O&M Halyard, Inc. 53

Showing 12 of 230. All products under Non-Surgical Gown

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer