Performance Health

Rolyan Anti-Microbial Thumb Spica Liners, Small - 13"L x 3" W, 3/4" Wide 10/PK

Registry build 21.09.26
144manufacturers in China registered for this device type
59catalogue numbers in this listing

Who Else Makes It

Concentrated in Guangdong (36), Zhejiang (32), Jiangsu (30). 30 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code ILH
Manufacturer City Province Registered as Device types
Ningbo Ningyuan Import & Export Co., Ltd. Ningbo Zhejiang Contract manufacturer 80
Hengshui Gangsheng Medical Instruments Co., Ltd. Hengshui Hebei Contract manufacturer 36
Shanghai Leison Medical & Healthcare Products Co., Ltd. Shanghai Shanghai Contract manufacturer 32
Zhejiang Anji Huabu Industrial Co., Ltd. Huzhou Zhejiang Contract manufacturer 32
Planet (Anhui) Medical Products Co., Ltd. Chuzhou Anhui Contract manufacturer 30
Zhongshan Chukuang Textile Co., Ltd. Zhongshan Guangdong Contract manufacturer 26
Lingxian Dongsheng Textile Co., Ltd. Dezhou Shandong Contract manufacturer 23
Allmay Bodywear (Shenzhen) Co., Ltd. Shenzhen Guangdong Contract manufacturer 21
Beijing Jinwei Kangda Medical Instrument Ltd. Langfang Hebei Contract manufacturer 21
Hengshui Xukang Medical Appliances Co., Ltd. Hengshui Hebei Contract manufacturer 21
Wellpower Sporting Goods Co., Ltd. Dong Guan Guangdong Contract manufacturer 18
Anhui Kangfu Industrial Foreign Trade Co., Ltd. Tianchang Anhui Contract manufacturer 18

Showing 12 of 144. All 144 manufacturers in China registered for Splint, Hand, And Components

Record

Regulatory record for Performance Health
Listed by ASP Global, LLC, United States
FDA product code ILH
Device type Splint, Hand, And Components
Device class Class 1
Regulation 21 CFR 890.3475
Establishment Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer
Premarket notification Exempt
Record published 2022-04-04
Record revised 2024-02-05 (version 3)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Latex Contains natural rubber latex

Catalogue Numbers

Catalogue numbers for Performance Health
Catalogue number Size Status
55328203 In distribution
A99762 In distribution
55328104 In distribution
55328205 In distribution
55328201 In distribution
A99770 In distribution
A99785 In distribution
791701 In distribution
A99764 In distribution
A99774 In distribution
560416 In distribution
744401 In distribution
A99771 In distribution
A99775 In distribution
55328101 In distribution
A99767 In distribution
A99765 In distribution
A99761 In distribution
A99782 In distribution
791703 In distribution
A99769 In distribution
A99784 In distribution
A99787 In distribution
55328109 In distribution
560420 In distribution
55328108 In distribution
55328110 In distribution
55328204 In distribution
562792 In distribution
55328202 In distribution
A99777 In distribution
7444 In distribution
A99789 In distribution
A37147 In distribution
55328207 In distribution
55328209 In distribution
A99763 In distribution
A99760 In distribution
A99776 In distribution
A99788 In distribution
A99781 In distribution
A99772 In distribution
55328208 In distribution
A99766 In distribution
791702 In distribution
55328206 In distribution
A99768 In distribution
A99783 In distribution
55328106 In distribution
560414 In distribution
A99780 In distribution
55328210 In distribution
55328107 In distribution
A99786 In distribution
55328105 In distribution
744402 In distribution
562791 In distribution
55328103 In distribution
55328102 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
DeRoyal Deroyal Industries, Inc. 1,511
Splint, Hand, And Components Tetra Medical Supply Corp. 111
Plastalume Brownmed 102
BMI Blake Manufacturing, Inc. 87
Panacea Blake Manufacturing, Inc. 78
Klarity Medical Klarity Medical Products, LLC 65
Vive Vive Health LLC 61
McKie Thumb Splint Pediatric Mckie Splints, LLC 60
McKie Thumb Splint Adult Mckie Splints, LLC 47
Wrist Lacer Medical Specialties, Inc. 38
Elite Orthopaedics Elite Orthopaedics, Inc. 34
Ryno Lacer Wrist and Thumb Support Medical Specialties, Inc. 31

Showing 12 of 254. All products under Splint, Hand, And Components

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