Microtek
Toga Gown, Zippered, XXL, Freedom Aire W/Filter, 12-PACK
68manufacturers in China registered for this device type
16catalogue numbers in this listing
2510(k) clearances naming this product code
4recalls on this 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 | Microtek Medical LLC, United States |
|---|---|
| FDA product code | FYA |
| Device type | Gown, Surgical |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4040 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer |
| 510(k) | K910515 |
| Record published | 2017-03-10 |
| Record revised | 2025-02-05 (version 8) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Ethylene Oxide |
| Supplied sterile | Yes |
| Single use | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Store under normal warehouse conditions. |
| Packaging | Pack of 10, pack of 12, pack of 24, pack of 25, pack of 300 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | 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 |
|---|---|
| K102971 | 2011-02-23 |
| K062899 | 2007-01-25 |
Recalls Naming This Product
4 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Microtek Medical LLC | 510(k) number | 2015-03-10 | Class II | Error in labeling | This recall is being conducted because a cohesive band used to package the devices contains latex and the product is not labeled as required by 21 CFR 801.437; it does not contain Caution: The Packaging of This Product Contains Natural Rubb | 10 units | 2017-01-21 |
| Microtek Medical LLC | 510(k) number | 2015-03-10 | Class II | Error in labeling | This recall is being conducted because a cohesive band used to package the devices contains latex and the product is not labeled as required by 21 CFR 801.437; it does not contain Caution: The Packaging of This Product Contains Natural Rubb | 38 units | 2017-01-21 |
| Microtek Medical LLC | 510(k) number | 2015-03-10 | Class II | Error in labeling | This recall is being conducted because a cohesive band used to package the devices contains latex and the product is not labeled as required by 21 CFR 801.437; it does not contain Caution: The Packaging of This Product Contains Natural Rubb | 153 Units | 2017-01-21 |
| Microtek Medical LLC | 510(k) number | 2015-03-10 | Class II | Error in labeling | This recall is being conducted because a cohesive band used to package the devices contains latex and the product is not labeled as required by 21 CFR 801.437; it does not contain Caution: The Packaging of This Product Contains Natural Rubb | 11 units | 2017-01-21 |
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.