Albahealth

10" x 48" IMPERVIOUS POLYESTER

Registry build 21.09.26
39manufacturers in China registered for this device type
72catalogue numbers in this listing

Who Else Makes It

Concentrated in Jiangsu (14), Zhejiang (6), Guangdong (6). 21 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code KKX
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
Dongguan Shin YI Healthcare Products Factory Dong Guan Guangdong Contract manufacturer 30
Exact Medical Manufacturing, Inc. Changzhou Jiangsu Contract manufacturer 17
Jiangsu Likang Medical Products Co., Ltd. Wujiang Jiangsu Contract manufacturer 17
Changzhou Holymed Products Co., Ltd. Changzhou Jiangsu Contract manufacturer 16
Xiantao Daoqi Plastic Co., Ltd. Xiantao Hubei Contract manufacturer 16
Heyuan Hong DE Medical Products Co., Ltd. Heyuan Guangdong Contract manufacturer 13
Wuhan Huaxin Nonwoven Co., Ltd. Wuhan Hubei Contract manufacturer 13
Foshan Nanhai Plus Medical Co Ltd Foshan Guangdong Contract manufacturer 12
Kunshan Jiehong Nonwoven Product Co., Ltd. Kunshan Jiangsu Contract manufacturer 12

Showing 12 of 39. All 39 manufacturers in China registered for Drape, Surgical, Antimicrobial

Record

Regulatory record for Albahealth
Listed by Albahealth, LLC, United States
FDA product code KKX
Device type Drape, Surgical, Antimicrobial
Device class Class 2
Regulation 21 CFR 878.4370
510(k) K792357
Record published 2016-09-22
Record revised 2021-12-22 (version 6)

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
Packaging Pack of 12, pack of 56, pack of 40, pack of 48, pack of 10, pack of 80
UDI direct marking Exempt

Catalogue Numbers

Catalogue numbers for Albahealth
Catalogue number Size Status
C21048009990304 In distribution
C85507009990304 In distribution
C91048009990902 In distribution
C90948009990902 In distribution
0N5506009990902 In distribution
0N5408009990902 In distribution
C01048009990304 In distribution
090948009990902 In distribution
091248009990902 In distribution
020630009990304 In distribution
C85509009990304 In distribution
0N5518009990902 In distribution
CN5506009990902 In distribution
C20630009990304 In distribution
CT5509009990902 In distribution
0N5508009990902 In distribution
0N5530009990902 In distribution
090838009990902 In distribution
CS5509009990304 In distribution
020838009990304 In distribution
000838009990304 In distribution
C85530009990304 In distribution
CN5412009990902 In distribution
CN5408009990902 In distribution
CN5509009990902 In distribution
C90838009990902 In distribution
091048009990902 In distribution
021048009990304 In distribution
0C5569009990902 In distribution
0T5012009990902 In distribution
000630009990304 In distribution
0C5589009990902 In distribution
090630009990902 In distribution
C85512009990304 In distribution
CS5512009990304 In distribution
0T5412009990902 In distribution
CN5508009990902 In distribution
0S5509009990304 In distribution
C20838009990304 In distribution
085512009990304 In distribution
CN5518009990902 In distribution
0N5507009990902 In distribution
CT5636009990902 In distribution
0S5512009990304 In distribution
C91248009990902 In distribution
CT5412009990902 In distribution
0N5512009990902 In distribution
0N5416009990902 In distribution
CN5504009990902 In distribution
CT5512009990902 In distribution
CT5507009990902 In distribution
0N5412009990902 In distribution
0M5108009990902 In distribution
C90630009990902 In distribution
CN5507009990902 In distribution
CN5012009990902 In distribution
085507009990304 In distribution
0S5012009990304 In distribution
CN5416009990902 In distribution
085508009990304 In distribution
CS5012009990304 In distribution
0T5509009990902 In distribution
0N5564009990902 In distribution
CN5512009990902 In distribution
CT5012009990902 In distribution
CN5530009990902 In distribution
0T5512009990902 In distribution
C85508009990304 In distribution
CN5536009990902 In distribution
085509009990304 In distribution
0N5509009990902 In distribution
0N5538009990902 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Microtek Microtek Medical LLC 994
Exact Medical Manufacturing, Inc. Exact Medical Manufacturing, Inc. 819
Halyard O&M Halyard, Inc. 800
Medline Medline Industries, Inc. 517
Convertors Cardinal Health 200, LLC 392
Medline Industries, Inc. Medline Industries, Inc. 274
TIDIShield Tidi Products, LLC 187
DeRoyal Deroyal Industries, Inc. 118
Cardinal Health Cardinal Health 200, LLC 111
Angiosystems Drape Angiosystems, Inc. 109
ComPel Surgical Drape Standard Textile Co., Inc. 101
Drape, Surgical, Antimicrobial Welmed, Inc. 95

Showing 12 of 329. All products under Drape, Surgical, Antimicrobial

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