Reinforce Surgical Gown (Aami Level 3)
20 catalogue numbers from PM5015RGS, listed by Foshan Nanhai Plus Medical Co Ltd, China, under Gown, Surgical. 68 manufacturers in China are registered for this product code.
68manufacturers in China registered for this device type
20catalogue numbers in this listing
5510(k) clearances naming this product code
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.
| 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
| Listed by | Foshan Nanhai Plus Medical Co Ltd, China |
|---|---|
| FDA product code | FYA |
| Device type | Gown, Surgical |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4040 |
| Establishment | Contract manufacturer, Private-label distributor, Manufacturer, Exporter |
| 510(k) | K210143 |
| Record published | 2021-09-28 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Ethylene Oxide |
| Supplied sterile | Yes |
| Single use | Yes |
| Over the counter | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Pack of 50 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| PM5015RGS | In distribution | |
| PM5001RGN | In distribution | |
| PM5012RGN | In distribution | |
| PM5015RGN | In distribution | |
| PM5005RGS | In distribution | |
| PM5004RGN | In distribution | |
| PM5014RGS | In distribution | |
| PM5002RGN | In distribution | |
| PM5003RGN | In distribution | |
| PM5011RGN | In distribution | |
| PM5011RGS | In distribution | |
| PM5013RGS | In distribution | |
| PM5003RGS | In distribution | |
| PM5005RGN | In distribution | |
| PM5002RGS | In distribution | |
| PM5004RGS | In distribution | |
| PM5014RGN | In distribution | |
| PM5001RGS | In distribution | |
| PM5012RGS | In distribution | |
| PM5013RGN | In distribution |
Same 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K222480 | 2022-11-14 |
| K213177 | 2022-05-11 |
| K211036 | 2022-05-04 |
| K210143 | 2021-07-22 |
| K133075 | 2015-06-24 |
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.