Tex-Care Medical
12X36 IMP LINER-TUBE-15"LINER
39manufacturers in China registered for this device type
40catalogue numbers in this listing
1510(k) clearance
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.
| 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
| Listed by | Flynt Amtex, Inc., United States |
|---|---|
| FDA product code | KKX |
| Device type | Drape, Surgical, Antimicrobial |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4370 |
| 510(k) | K955749 |
| Record published | 2021-10-29 |
| Record revised | 2021-12-22 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Ethylene Oxide, Radiation Sterilization |
| Single use | Yes |
| Over the counter | Yes |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 81150-648 | In distribution | |
| 91160-930 | In distribution | |
| 81160-848 | In distribution | |
| 91150-648 | In distribution | |
| 91161-254 | In distribution | |
| 81174-838 | In distribution | |
| 81151-248 | In distribution | |
| 91150-848 | In distribution | |
| 91160-848 | In distribution | |
| 91161-030 | In distribution | |
| 81161-648 | In distribution | |
| 91160-648 | In distribution | |
| 91161-260 | In distribution | |
| 81171-248 | In distribution | |
| 91150-918 | In distribution | |
| 91164-948 | In distribution | |
| 81161-254 | In distribution | |
| 81161-048 | In distribution | |
| 81162-448 | In distribution | |
| 81160-936 | In distribution | |
| 81160-838 | In distribution | |
| 91150-948 | In distribution | |
| 91160-936 | In distribution | |
| 91161-448 | In distribution | |
| 81174-930 | In distribution | |
| 81164-948 | In distribution | |
| 81161-260 | In distribution | |
| 81170-944 | In distribution | |
| 91170-944 | In distribution | |
| 91151-248 | In distribution | |
| 91151-260 | In distribution | |
| 81160-630 | In distribution | |
| 91160-630 | In distribution | |
| 91171-248 | In distribution | |
| 81174-948 | In distribution | |
| 81150-948 | In distribution | |
| 91160-838 | In distribution | |
| 81161-448 | In distribution | |
| 91161-048 | In distribution | |
| 91141-236 | In distribution |
Same 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K955749 | 1996-11-22 |
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.