ACE

Sani-Sleeve 2X60 NON-Sterile 20/SLV 30SLV/CA (600EA)

Registry build 21.09.26
439manufacturers in China registered for this device type
3catalogue 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 ACE
Listed by Ace Surgical Supply Co., Inc., United States
FDA product code LYU
Device type Accessory, Surgical Apparel
Device class Class 1
Regulation 21 CFR 878.4040
Premarket notification Exempt
Record published 2019-10-16
Record revised 2024-09-11 (version 4)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Single use Yes
Prescription Prescription only
Label carries lot or batch number
Storage Special storage condition: No special storage conditions required
Sizes Length 60 in
UDI direct marking Exempt

Catalogue Numbers

Catalogue numbers for ACE
Catalogue number Size Per pack Status
0031059 Length 60 in 600 In distribution
4842003 In distribution
4842002 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