Invenio
Surgical Gown_Raglan Sleeve_W/reinforcement_Large_Invenio Extra Long_W/ 1 hand towel_Sterile_22ea/cs
68manufacturers in China registered for this device type
126catalogue numbers in this listing
1510(k) clearance
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 | GRI Medical & Electronic Technology Co., Ltd., China |
|---|---|
| FDA product code | FYA |
| Device type | Gown, Surgical |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4040 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Manufacturer, Exporter |
| 510(k) | K162442 |
| Record published | 2024-02-02 |
| Record revised | 2026-05-11 (version 2) |
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, expiry date |
| Packaging | Pack of 24, pack of 22, pack of 28, pack of 26, pack of 32, pack of 20 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| i91-6120 | 40 | In distribution | |
| RM0742392 | 44 | In distribution | |
| i90-7050-S1 | In distribution | ||
| i91-4330-HB | 324 | In distribution | |
| i90-4320-HB | 378 | In distribution | |
| i90-4220-W1-HB | 378 | In distribution | |
| i90-1230-HB | 324 | In distribution | |
| i91-4330-S1 | In distribution | ||
| i91-6130-S1 | In distribution | ||
| i90-1242-S1 | In distribution | ||
| i91-6130 | 40 | In distribution | |
| i90-8230-S1 | In distribution | ||
| i90-7020-S1 | In distribution | ||
| i91-6120-W1 | 36 | In distribution | |
| i90-8033-S1 | In distribution | ||
| i90-4320-S1 | In distribution | ||
| i90-8240-S1 | In distribution | ||
| i90-4220-HB | 378 | In distribution | |
| i90-1230-S1 | In distribution | ||
| i91-6142-S1 | In distribution | ||
| i91-4320-S1 | In distribution | ||
| i90-7000-S1 | In distribution | ||
| i91-6132VERII-S1 | In distribution | ||
| i91-6142 | 32 | In distribution | |
| i90-1240-HB | 324 | In distribution | |
| i90-8010 | 40 | In distribution | |
| i90-8234-S1 | In distribution | ||
| i91-6124 | 32 | In distribution | |
| i91-1242-S1 | In distribution | ||
| i91-4222 | 32 | In distribution | |
| i90-8232 | 28 | In distribution | |
| i90-8040-S1 | In distribution | ||
| i90-8232-S1 | In distribution | ||
| i91-1234-W1-HB | 270 | In distribution | |
| i91-1220-W1-HB | 378 | In distribution | |
| i91-6130-HB | 378 | In distribution | |
| i91-1242 | 24 | In distribution | |
| i91-4232 | 32 | In distribution | |
| i90-8032 | 32 | In distribution | |
| i91-4340-S1 | In distribution | ||
| i91-4220-W1-HB | 378 | In distribution | |
| i91-1220-HB | 378 | In distribution | |
| i90-8022-S1 | In distribution | ||
| i91-6122 | 32 | In distribution | |
| i91-4230-HB | 324 | In distribution | |
| i91-4320-HB | 378 | In distribution | |
| i91-4230 | 32 | In distribution | |
| i91-6120-S1 | In distribution | ||
| i91-6150-S1 | In distribution | ||
| i90-7042-S1 | In distribution | ||
| i90-8032-S1 | In distribution | ||
| i91-4230-W1-HB | 324 | In distribution | |
| i91-6130VERII-S1 | In distribution | ||
| i91-6140VERII-S1 | In distribution | ||
| i91-6122VERII-S1 | In distribution | ||
| i91-4242 | 28 | In distribution | |
| i91-6120VERII-S1 | In distribution | ||
| i91-6132-S1 | In distribution | ||
| i90-8020-W1-HB | 405 | In distribution | |
| i90-8220-S1 | In distribution | ||
| i91-4220-HB | 378 | In distribution | |
| i91-1230-W1-HB | 324 | In distribution | |
| i91-4200 | 40 | In distribution | |
| i90-4232 | 32 | In distribution | |
| i90-8010-S1 | In distribution | ||
| i91-6132 | 32 | In distribution | |
| i91-1222-S1 | In distribution | ||
| i90-7010-S1 | In distribution | ||
| i90-8020-HB | 432 | In distribution | |
| i91-6122-S | In distribution | ||
| i90-1220-HB | 378 | In distribution | |
| i91-4210 | 40 | In distribution | |
| i90-8242 | 24 | In distribution | |
| i91-4020-HB | 432 | In distribution | |
| i90-8200 | 32 | In distribution | |
| i91-4320-W1-HB | 378 | In distribution | |
| i91-4240 | 32 | In distribution | |
| i90-7040-S1 | In distribution | ||
| i90-7022-S1 | In distribution | ||
| i91-6134-S1 | In distribution | ||
| 90-8010-S1 | In distribution | ||
| i90-7032-S1 | In distribution | ||
| i91-6134 | 32 | In distribution | |
| i91-6150 | 32 | In distribution | |
| i91-1232-S1 | In distribution | ||
| i90-4330-S1 | In distribution | ||
| i90-8040-HB | 324 | In distribution | |
| i91-6124-S1 | In distribution | ||
| i91-1232 | 28 | In distribution | |
| i91-6110-S1 | In distribution | ||
| i90-8224-S1 | In distribution | ||
| i90-8000-S1 | In distribution | ||
| i90-8042-S1 | In distribution | ||
| i90-8030-W1-HB | 378 | In distribution | |
| i91-4220 | 36 | In distribution | |
| i90-8000 | 32 | In distribution | |
| i91-4330-W1-HB | 324 | In distribution | |
| i90-2232 | 36 | In distribution | |
| i90-8200-S1 | In distribution | ||
| i91-1200-S1 | In distribution | ||
| i90-8050-S1 | In distribution | ||
| i90-8040-W1-HB | 324 | In distribution | |
| i91-6140-S1 | In distribution | ||
| i91-6140 | 36 | In distribution | |
| i90-8042-W1-HB | 297 | In distribution | |
| i90-1232 | 28 | In distribution | |
| i90-8222-S1 | In distribution | ||
| i91-1234-S1 | In distribution | ||
| i91-1230-S1 | In distribution | ||
| i91-6130-W1 | 36 | In distribution | |
| i90-8222 | 32 | In distribution | |
| i91-4340-HB | 324 | In distribution | |
| i90-2045-S | In distribution | ||
| i91-1240-S1 | In distribution | ||
| i90-8230-HB | 324 | In distribution | |
| i91-1234 | 24 | In distribution | |
| i91-1220-S1 | In distribution | ||
| i90-2032-S | In distribution | ||
| i91-1230-HB | 324 | In distribution | |
| i90-8030-HB | 378 | In distribution | |
| i91-6110 | 40 | In distribution | |
| i90-7030-S1 | In distribution | ||
| i90-8210 | 36 | In distribution | |
| i91-6122-S1 | In distribution | ||
| i91-1020-S2 | In distribution | ||
| i90-8210-S1 | 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 |
| 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 |
| Cardinal Health | Cardinal Health 200, LLC | 35 |
Showing 12 of 172. All products under Gown, Surgical
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K102652 | 2011-02-03 |
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.