Alleset
Alleset Gown_no reinforcement_X-Large_35g SMS_With one towel_without CSR_Handi-Bin_Non-Sterile_468ea/cs
68manufacturers in China registered for this device type
214catalogue 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 | 2021-04-22 |
| Record revised | 2024-11-18 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Ethylene Oxide |
| Supplied sterile | Yes |
| Single use | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, serial number |
| Packaging | Pack of 24, pack of 26, pack of 22, carton of 27, carton of 22 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| Model 90-4030 | 44 | In distribution | |
| 91-6134 | 32 | In distribution | |
| V90-2220 | 44 | In distribution | |
| 90-8232-S1 | In distribution | ||
| V90-2220-S | In distribution | ||
| Model 90-2040 | 44 | In distribution | |
| Model 90-3631-S2 | In distribution | ||
| Model 92-2030-S2 | In distribution | ||
| Model 46671-00 | 18 | In distribution | |
| Model 90-4220-W1 | 36 | In distribution | |
| Model 47283-80 | 14 | In distribution | |
| 46668-81 | In distribution | ||
| 90-2020-HB | 468 | In distribution | |
| 90-8234-S1 | In distribution | ||
| 90-802025-S2-RT | In distribution | ||
| V90-2220-S2 | In distribution | ||
| 92-4020-HB | 432 | In distribution | |
| V90-2230 | 44 | In distribution | |
| Model 46672-00 | 18 | In distribution | |
| V90-120040-S2-RT | In distribution | ||
| i90-4230-HB | 324 | In distribution | |
| V90-2231 | 44 | In distribution | |
| Model 92-4331-S2 | In distribution | ||
| V90-4230 | 36 | In distribution | |
| V90-122025-S2-RT | In distribution | ||
| V90-2030-S2 | In distribution | ||
| Model 90-2040-S2 | In distribution | ||
| V90-4230-S2 | In distribution | ||
| Model 90-2020-W1-HB | 486 | In distribution | |
| 91-5130-S1 | In distribution | ||
| V90-124040-S2-RT | In distribution | ||
| Model 46669-00 | 19 | In distribution | |
| V90-4031-S2 | In distribution | ||
| V90-4221 | 36 | In distribution | |
| V90-2020-S | In distribution | ||
| V90-2040-S2 | In distribution | ||
| V90-2010 | 48 | In distribution | |
| 90-4030-S | In distribution | ||
| V90-2020-S2 | In distribution | ||
| V90-4030 | 44 | In distribution | |
| Model 90-4020 | 44 | In distribution | |
| Model 92-4231-S2 | In distribution | ||
| V90-2221 | 44 | In distribution | |
| Model 90-1331-S1 | In distribution | ||
| SF90-2220-S2 | In distribution | ||
| 90-8230-S1 | In distribution | ||
| V90-4210 | 36 | In distribution | |
| V90-2221-S2 | In distribution | ||
| Model 90-3820-S2 | In distribution | ||
| Model 90-3831-S2 | In distribution | ||
| V90-4030-S2 | In distribution | ||
| Model 90-3630-S2 | In distribution | ||
| Model 90-4020-W1 | 36 | In distribution | |
| 90-2030-HB | 468 | In distribution | |
| Model 90-3630 | 32 | In distribution | |
| 90-8224-S1 | In distribution | ||
| SF90-2030-S2 | In distribution | ||
| Model 90-8030-HB | 378 | In distribution | |
| 90-8210-S1 | In distribution | ||
| S90-3040-S2CC | In distribution | ||
| 46674-81 | In distribution | ||
| Model 90-4230-W1 | 36 | In distribution | |
| V90-2240 | 36 | In distribution | |
| Model 46670-80 | 18 | In distribution | |
| 90-8000-S1 | In distribution | ||
| V90-2321-S2 | In distribution | ||
| Model 90-2030-S2 | In distribution | ||
| Model 47282-80 | 16 | In distribution | |
| S90-3020-S2CC | In distribution | ||
| 92-2040 | 44 | In distribution | |
| S90-3230-S2CC | In distribution | ||
| Model 90-1200-S1 | In distribution | ||
| V90-4220 | 36 | In distribution | |
| 46669-81 | In distribution | ||
| V90-2241-S2 | In distribution | ||
| V90-4010 | 40 | In distribution | |
| Model 90-1330-S1 | In distribution | ||
| V90-2020 | 48 | In distribution | |
| 90-801040-S2-RT | In distribution | ||
| SF90-2231-S2 | In distribution | ||
| 90-8240-S1 | In distribution | ||
| 91-6122VERII-S2 | In distribution | ||
| 90-801025-S2-RT | In distribution | ||
| i90-8020-S1 | In distribution | ||
| V90-2020-W2 | 44 | In distribution | |
| Model 46677-80 | 17 | In distribution | |
| Model 92-2230-S2 | In distribution | ||
| Model 90-8030 | 36 | In distribution | |
| V90-2031-S2 | In distribution | ||
| V90-123025-S2-RT | In distribution | ||
| 90-8020-S1 | In distribution | ||
| V90-4220-S2 | In distribution | ||
| 90-2320-S | In distribution | ||
| V90-2040 | 44 | In distribution | |
| V90-2210-S2 | In distribution | ||
| 90-2020-W1 | 48 | In distribution | |
| V90-124025-S2-RT | In distribution | ||
| 90-803025-S2-RT | In distribution | ||
| V90-2031 | 48 | In distribution | |
| V90-4020 | 44 | In distribution | |
| V90-4240-S2 | In distribution | ||
| Model 90-1340 | 32 | In distribution | |
| 46670-81 | In distribution | ||
| V90-4021 | 44 | In distribution | |
| Model 47284-80 | 12 | In distribution | |
| Model 90-2020-T1-HB | 486 | In distribution | |
| ALC90-2020-HB | 468 | In distribution | |
| 90-2230-S | In distribution | ||
| 92-4031-W2-HB | 324 | In distribution | |
| GH90-8020-S1 | In distribution | ||
| S90-3030-S2CC | In distribution | ||
| Model 90-4330-HB | 324 | In distribution | |
| V90-4210-S2 | In distribution | ||
| 90-2020-S | In distribution | ||
| V90-122040-S2-RT | In distribution | ||
| V90-2030 | 48 | In distribution | |
| V90-2021 | 48 | In distribution | |
| Model 92-2220-S2 | In distribution | ||
| Model 46677-00 | 17 | In distribution | |
| Model 46669-80 | 19 | In distribution | |
| V90-2021-S2 | In distribution | ||
| Model 46670-00 | 18 | In distribution | |
| V90-2030-W2 | 40 | In distribution | |
| Model 92-2020-S2 | In distribution | ||
| 46667-81 | In distribution | ||
| Model 90-3620 | 40 | In distribution | |
| Model 46672-80 | 18 | In distribution | |
| 90-804040-S2-RT | In distribution | ||
| SF90-2031-S2 | In distribution | ||
| V90-2010-S2 | In distribution | ||
| ALC90-2030-T1-HB | 468 | In distribution | |
| SF90-8032-S1 | In distribution | ||
| Model 92-2330-S2 | In distribution | ||
| ALC90-2030-W1-HB | 468 | In distribution | |
| V90-4040 | 40 | In distribution | |
| Model 46680-00 | 14 | In distribution | |
| 46666-81 | In distribution | ||
| GH90-8030-S1 | In distribution | ||
| 90-8220-S1 | In distribution | ||
| V90-4010-S2 | In distribution | ||
| V90-2330-S2 | In distribution | ||
| 90-2220-S | In distribution | ||
| V90-4040-S2 | In distribution | ||
| 90-802040-S2-RT | In distribution | ||
| 46671-81 | In distribution | ||
| ALC90-2040-HB | 468 | In distribution | |
| SF90-8020-S1 | In distribution | ||
| 90-8020-S | In distribution | ||
| V90-2230-S2 | In distribution | ||
| 92-2030-W2-HB | 378 | In distribution | |
| 90-8242-S1 | In distribution | ||
| Model 46678-80 | 16 | In distribution | |
| Model 90-4030-HB | 432 | In distribution | |
| Model 97-8000 | 120 | In distribution | |
| 90-8030ST | 25 | In distribution | |
| GH90-8032-S1 | In distribution | ||
| Model 90-1210-S1 | In distribution | ||
| Model 90-2240-S2 | In distribution | ||
| V90-4021-S2 | In distribution | ||
| Model 92-2320-S2 | In distribution | ||
| V90-123225-S2-RT | In distribution | ||
| S90-3240-S2CC | In distribution | ||
| V90-4221-S2 | In distribution | ||
| Model 46679-80 | 16 | In distribution | |
| SF90-8030-S1 | In distribution | ||
| ALC90-2020-W1-HB | 468 | In distribution | |
| V90-2240-S2 | In distribution | ||
| V90-2331-S2 | In distribution | ||
| Model 90-2020-S2 | In distribution | ||
| Model 90-4020-HB | 432 | In distribution | |
| V90-4231-S2 | In distribution | ||
| 92-4030-HB | 432 | In distribution | |
| 90-1020 | 40 | In distribution | |
| 92-4020-S1 | In distribution | ||
| V90-4240 | 28 | In distribution | |
| 90-2030-W1-HB | 468 | In distribution | |
| V90-2210 | In distribution | ||
| 90-8222-S1 | In distribution | ||
| Model 90-4030-S2 | In distribution | ||
| SF90-2020-S2 | In distribution | ||
| 91-6132VERII-S2 | In distribution | ||
| 90-4220-S | In distribution | ||
| Model 46680-80 | 14 | In distribution | |
| V90-2230-S | In distribution | ||
| Model 92-2031-S2 | In distribution | ||
| Model 90-8020 | 40 | In distribution | |
| V90-2320-S2 | In distribution | ||
| ALC90-2030-HB | 468 | In distribution | |
| 90-2030-T1-HB | 468 | In distribution | |
| 90-8200-S1 | In distribution | ||
| Model 90-1330 | 36 | In distribution | |
| ALC90-2020-T1-HB | 468 | In distribution | |
| Model 92-2231-S2 | In distribution | ||
| SGXXLR | 32 | In distribution | |
| V90-4031 | 44 | In distribution | |
| 46665-81 | In distribution | ||
| 91-6140VERII-S2 | In distribution | ||
| Model 46671-80 | 18 | In distribution | |
| V90-2231-S2 | In distribution | ||
| 60300452 | 36 | In distribution | |
| 90-803040-S2-RT | In distribution | ||
| Model 90-1230-HB | 378 | In distribution | |
| Model 90-1320 | 36 | In distribution | |
| 46673-81 | In distribution | ||
| 91-6130VERII-S2 | In distribution | ||
| V90-2030-S | In distribution | ||
| 91-6120VERII-S2 | In distribution | ||
| V90-4020-S2 | In distribution | ||
| 90-2040-HB | 468 | In distribution | |
| Model 90-1240-S1 | In distribution | ||
| i90-8030-S1 | In distribution | ||
| Model 90-3620-S2 | In distribution | ||
| Model 90-1320-S1 | In distribution | ||
| RM0742392-HB | 403 | 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 |
| 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 |
| 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.