Yadu

YADU Surgical Gowns are intended to be worn by operating room personnel during surgical procedure to protect boththe surgical patient and the operating room personnel from transfer of…

Registry build 21.09.26

YADU Surgical Gowns are intended to be worn by operating room personnel during surgical procedure to protect boththe surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulatematerial. The surgical gowns meet the requirements for Level 2 and Level 3 classification Per ANSI/AAMI PB70.

68manufacturers in China registered for this device type
12catalogue numbers in this listing

Who Else Makes It

Concentrated in Jiangsu (16), Hubei (13), Anhui (10). 28 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code FYA
Manufacturer City Province Registered as Device types
GRI Medical & Electronic Technology Co., Ltd. Jiaxing Zhejiang Contract manufacturer 71
Suzhou Meccan Import and Export Corp. Suzhou Jiangsu Contract manufacturer 71
Principle & Will Biotech (Pinghu) Co., Ltd. Pinghu Zhejiang Contract manufacturer 39
Henan Yadu Industrial Co., Ltd. Changyuan Henan Contract manufacturer 35
Jiangsu JianYu Health Medical Co., Ltd. Changzhou Jiangsu Contract manufacturer 35
Sino Protection (Hefei) Medical Products Co., Ltd. Hefei Anhui Contract manufacturer 18
Exact Medical Manufacturing, Inc. Changzhou Jiangsu Contract manufacturer 17
Kingstar Medical (Xianning) Co., Ltd. Xianning Hubei Contract manufacturer 17
Changzhou Holymed Products Co., Ltd. Changzhou Jiangsu Contract manufacturer 16
Weihai Dishang Medical Technology Co., Ltd. Weihai Shandong Contract manufacturer 16
Lianyungang Bronson Non-woven Products Co., Ltd. Lianyungang Jiangsu Contract manufacturer 16
Heyuan Hong DE Medical Products Co., Ltd. Heyuan Guangdong Contract manufacturer 13

Showing 12 of 68. All 68 manufacturers in China registered for Gown, Surgical

Record

Regulatory record for Yadu
Listed by Henan Yadu Industry Co., Ltd.
FDA product code FYA
Device type Gown, Surgical
Device class Class 2
Regulation 21 CFR 878.4040
510(k) K220092
Record published 2026-04-20

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Supplied sterile Yes
Single use Yes
Latex Labelled latex-free
Label carries lot or batch number, expiry date, manufacturing date, serial number

Catalogue Numbers

Catalogue numbers for Yadu
Catalogue number Size Status
SY0137 In distribution
SY0178 In distribution
SY0179 In distribution
SY0151 In distribution
SY0136 In distribution
SY0172 In distribution
SY0138 In distribution
SY0149 In distribution
SY0173 In distribution
SY0150 In distribution
SY0139 In distribution
SY0148 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Medline Medline Industries, Inc. 453
Halyard O&M Halyard, Inc. 248
Novo Health Services, LLC Novo Health Services, LLC 222
Alleset GRI Medical & Electronic Technology Co., Ltd. 214
Convertors Cardinal Health 200, LLC 184
Lac-Mac LAC-MAC Limited 157
Invenio GRI Medical & Electronic Technology Co., Ltd. 126
Exact Medical Manufacturing, Inc. Exact Medical Manufacturing, Inc. 107
ComPel Surgical Gown Standard Textile Co., Inc. 67
Halyard GRI Medical & Electronic Technology Co., Ltd. 55
ComPel MLR Surgical Gown Standard Textile Co., Inc. 38
Medline Industries, Inc. Medline Industries, Inc. 35

Showing 12 of 172. All products under Gown, Surgical

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