Tronex International, Inc.

Gown, Isolation, Spunbond with Microporous Laminate, Over-the-Head Thumb-Hook, Fluid Impervious, Latex-Free, White, Extra-Large

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 Tronex International, Inc.
Listed by Tronex International, Inc.
FDA product code OEA
Device type Non-Surgical Gown
Device class Class 1
Regulation 21 CFR 878.4040
Premarket notification Exempt
Record published 2022-10-28
Record revised 2025-08-14 (version 2)

Specifications

Specifications
MRI safety MR Safe
Single use Yes

Catalogue Numbers

Catalogue numbers for Tronex International, Inc.
Catalogue number Size Per pack Status
8999CHEMO40 50 In distribution
MLN46535Y 100 In distribution
554025Y 50 In distribution
6333CHEMO40 50 In distribution
5740B 50 In distribution
543125B 100 In distribution
6333CHEMO35 50 In distribution
SMS45125Y 100 In distribution
MLN51625Y 100 In distribution
543335Y 50 In distribution
577035W 40 In distribution
8999CHEMO25 50 In distribution
SMS10035Y 100 In distribution
541025Y 50 In distribution
8999CHEMO35 50 In distribution
MLN51735Y 100 In distribution
SMS45335Y 100 In distribution
SMS10010Y 100 In distribution
MLN51840Y 100 In distribution
SMS10020Y 100 In distribution
SMS10025Y 100 In distribution
542235Y 50 In distribution
554025B 50 In distribution
MLN46640Y 100 In distribution
543022Y 50 In distribution
546735Y 50 In distribution
546725Y 50 In distribution
543135B 100 In distribution
5440Y 50 In distribution
550035Y 50 In distribution
6333CHEMO25 50 In distribution
MLN46425Y 100 In distribution
577025W 40 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