Medline Industries, Inc.
Gown,sontara,poly-Reinforced,strl,xl
68manufacturers in China registered for this device type
35catalogue numbers in this listing
13510(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 | Medline Industries, Inc., United States |
|---|---|
| FDA product code | FYA |
| Device type | Gown, Surgical |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4040 |
| 510(k) | K140539 |
| Record published | 2016-10-14 |
| Record revised | 2022-06-17 (version 8) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Over the counter | Yes |
| Supplied as a kit | Yes |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Case of 24, case of 60, case of 10, case of 8, case of 32, case of 4 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| DYNJP2401 | L | In distribution |
| DYNJCD0189 | In distribution | |
| ACC010275 | In distribution | |
| DUN4000 | In distribution | |
| SPT-2705CS | In distribution | |
| RES2000 | In distribution | |
| PHS104789000 | In distribution | |
| SPT-2103CS | In distribution | |
| SPT-2209SMSCS | In distribution | |
| DYNJ0561216F | In distribution | |
| DUN5000 | In distribution | |
| DYNJP2907T | In distribution | |
| DYNJ0785864J | In distribution | |
| DYNJPBRGR1 | In distribution | |
| SPT-2704CS | In distribution | |
| DYNJP2902T | In distribution | |
| DYNJP2901T | In distribution | |
| DYNJP2402 | XL | In distribution |
| P526117 | In distribution | |
| SPT-2728CS | In distribution | |
| 168960 | In distribution | |
| 22701PCS | In distribution | |
| SPT-2001SMSCS | In distribution | |
| DYNJ0050263 | In distribution | |
| P526102 | In distribution | |
| DYNJ69175 | In distribution | |
| MTK6000 | In distribution | |
| DYKM1352A | In distribution | |
| SPT-2206CS | In distribution | |
| 22708PCS | In distribution | |
| SPT-2002CS | In distribution | |
| DYNJZ92485T | In distribution | |
| PRX-2802CS | In distribution | |
| ENGMICROLG15 | In distribution | |
| 22702PCS | 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 |
| Cardinal Health | Cardinal Health 200, LLC | 35 |
Showing 12 of 172. All products under Gown, Surgical
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K202447 | 2021-04-02 |
| K190950 | 2019-07-04 |
| K182172 | 2019-04-24 |
| K172954 | 2018-06-15 |
| K150598 | 2016-04-28 |
| K062969 | 2006-12-14 |
| K043585 | 2005-03-08 |
| K043017 | 2005-03-08 |
| K031933 | 2003-09-16 |
| K003755 | 2001-02-16 |
| K993170 | 2000-03-02 |
| K982694 | 1998-12-14 |
| K982693 | 1998-10-28 |
Recalls Naming This Product
2 recalls name this product by its own identifiers, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Medline Industries, LP – Northfield | UDI-DI | 2026-01-07 | Class II | Under Investigation by firm | Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have | 70,376,042 units |
| Medline Industries, LP – Northfield | UDI-DI | 2026-01-07 | Class II | Process control | Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have | 70376042 units |
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.