PremierPro

PremierPro Disposable Lab Coats Traditional Collar and Knit Cuffs, White, XXX-Large, 5/bg

Registry build 21.09.26
439manufacturers in China registered for this device type
31catalogue numbers in this listing

Who Else Makes It

Concentrated in Zhejiang (94), Jiangsu (82), Guangdong (69). 76 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code LYU
Manufacturer City Province Registered as Device types
Shanghai Joy Crown Industry Co., Ltd. Pu Dong New Area Shanghai Contract manufacturer 64
Gcmedica Enterprise Ltd.(Wuxi) Wuxi Jiangsu Contract manufacturer 55
Zhejiang Gongdong Medical Technology Co., Ltd. Taizhou Zhejiang Contract manufacturer 40
BH Medical Products Co., Ltd. Changzhou Jiangsu Contract manufacturer 37
Planet (Anhui) Medical Products Co., Ltd. Chuzhou Anhui Contract manufacturer 30
Zhongshan Chukuang Textile Co., Ltd. Zhongshan Guangdong Contract manufacturer 26
Jingmen Huasheng Asia Dynamics Sanitary Products Co., Ltd. Jingmen Hubei Contract manufacturer 23
Yiwu Haoding Medical Co., Ltd. Yiwu Zhejiang Contract manufacturer 23
Anji Hengfeng Sanitary Material Co., Ltd. Anji Zhejiang Contract manufacturer 20
Hochuen Medical Technology Co., Ltd. Shenzhen Guangdong Contract manufacturer 20
Goodwood Medical Care Ltd Dalian Liaoning Contract manufacturer 19
Wellpower Sporting Goods Co., Ltd. Dong Guan Guangdong Contract manufacturer 18

Showing 12 of 439. All 439 manufacturers in China registered for Accessory, Surgical Apparel

Record

Regulatory record for PremierPro
Listed by Prestige Ameritech, United States
FDA product code LYU
Device type Accessory, Surgical Apparel
Device class Class 1
Regulation 21 CFR 878.4040
Establishment Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer
Premarket notification Exempt
Record published 2020-07-30
Record revised 2026-03-23 (version 2)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Single use Yes
Latex Labelled latex-free
Label carries lot or batch number, manufacturing date
Packaging Case of 5, case of 3, case of 24, case of 100, case of 4, case of 10

Catalogue Numbers

Catalogue numbers for PremierPro
Catalogue number Size Status
26127 In distribution
26125 In distribution
2514 In distribution
26133 In distribution
2494 In distribution
2715 In distribution
26124 In distribution
26136 In distribution
2712 In distribution
2496 In distribution
2251 In distribution
26137 In distribution
2515 In distribution
2252 In distribution
26123 In distribution
2537 In distribution
26126 In distribution
2536 In distribution
2534 In distribution
26132 In distribution
2716 In distribution
2714 In distribution
2717 In distribution
26135 In distribution
2516 In distribution
2493 In distribution
26122 In distribution
26134 In distribution
2535 In distribution
2713 In distribution
2495 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Critical Cover Alpha Pro Tech, Inc. 177
Cardinal Health Cardinal Health 200, LLC 167
Halyard O&M Halyard, Inc. 117
Tronex International, Inc. Tronex International, Inc. 108
ASP Medical ASP Global, LLC 103
Unipack Unipack LLC 90
A Plus A Plus International, Inc 77
Maxi-Gard Henry Schein, Inc. 76
Resilient Medical Solutions Resilient Medical Solutions, LLC 61
Dukal Dukal LLC 58
MediChoice Owens & Minor Distribution, Inc. 55
VR Polyconversions, Inc. 50

Showing 12 of 197. All products under Accessory, Surgical Apparel

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