Medline
Xalt Level 4 Reusable Surgical Gown, Critical Coverage, Green, Snaps at Neck, Ties at Back, Size 2XL
68manufacturers in China registered for this device type
453catalogue 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) | K982694 |
| Record published | 2025-10-17 |
| Record revised | 2026-01-16 (version 8) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Over the counter | Yes |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Special storage condition: Avoid contact with an open flame or high intensity heat source |
| Packaging | Pack of 100, pack of 24, pack of 18, case of 18, pack of 30, case of 20 |
| Distribution end date | 2026-04-03 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| DYNJP2463P | In distribution | ||
| DYNJP2466P | In distribution | ||
| MDTL1349703BJ | In distribution | ||
| MDTZ1026280AL | In distribution | ||
| MDT012083S | In distribution | ||
| DYNJP2227S | In distribution | ||
| DYNJP2376P | L | In distribution | |
| MDTZ1187050AA | In distribution | ||
| MDT012080XXL | In distribution | ||
| DYNJP2208P | In distribution | ||
| MDTL1154340BT | 12 | In distribution | |
| MDT012081XL | In distribution | ||
| MDTZ1210949AA | In distribution | ||
| SYNDECONXL | In distribution | ||
| SRI7000L | In distribution | ||
| SPT-4001TBNSE | 528 | In distribution | |
| MDTZ1001605BB | In distribution | ||
| SPT-4002BNSE | 576 | In distribution | |
| MDT012080L | In distribution | ||
| SPT-2201SMSCS | In distribution | ||
| MDT012083L | In distribution | ||
| DYNJP2000 | In distribution | ||
| MDTL1154340Q | In distribution | ||
| MDTL1154340BZ | In distribution | ||
| DYNJP2706 | XXL | In distribution | |
| MDT012085L | In distribution | ||
| SPT-2002CS | Extra Large | 100 | In distribution |
| DYNJP2229P | In distribution | ||
| SPT-2103SMSCS | In distribution | ||
| PINK2001S | In distribution | ||
| DYNJP2804 | L | In distribution | |
| SPT-2228SMSCS | 100 | In distribution | |
| DYNJP2102 | XL | In distribution | |
| MDT012092XL | In distribution | ||
| DYNJP2724 | L | In distribution | |
| 35111 | In distribution | ||
| MDTL1018919BO | 12 | In distribution | |
| SPT-2208CS | Extra Large | 100 | In distribution |
| MDTZ1000893AH | In distribution | ||
| DYNJP2202SG | In distribution | ||
| DYNJP2013C | In distribution | ||
| DYNJP2363P | In distribution | ||
| DYNJP2212SLG | In distribution | ||
| MDT012062XL | In distribution | ||
| SPT-2101CS | 100 | In distribution | |
| SYN7444XL | In distribution | ||
| MDTL1349703BK | In distribution | ||
| DYNJP2003SG | In distribution | ||
| DYNJP2207S | L | In distribution | |
| DYNJP2469P | In distribution | ||
| SPT-2709CS | In distribution | ||
| DYNJP2101S | L | In distribution | |
| MDTZ1003787BB | In distribution | ||
| MDTL1007015KZ | In distribution | ||
| SPT-2205CS | In distribution | ||
| MDT012090XL | 12 | In distribution | |
| DYNJP2602 | XL | In distribution | |
| DYNJP2712 | In distribution | ||
| MDTL1018919BA | 12 | In distribution | |
| MDTASX10373 | In distribution | ||
| DYNJP2701 | L | In distribution | |
| DYNJP2476P | In distribution | ||
| MDT012090L | In distribution | ||
| MDTZ1196903G | In distribution | ||
| SRI7000S | In distribution | ||
| MDT012090XL | In distribution | ||
| MDTZ1024488BA | In distribution | ||
| MDT012092L | In distribution | ||
| DYNJP2209 | In distribution | ||
| MDTL1058365AS | In distribution | ||
| 33708P | In distribution | ||
| MDTZ1029213BB | 12 | In distribution | |
| SPT-2003SMSCS | In distribution | ||
| DYNJP2004 | 3XL | In distribution | |
| DYNJP2207 | In distribution | ||
| DYNJP2808 | XL | In distribution | |
| MDT012086L | 12 | In distribution | |
| SPT-2708CS | 100 | In distribution | |
| MDT012084L | In distribution | ||
| MDT012081L | In distribution | ||
| MDT012091XXL | In distribution | ||
| MDT012083M | In distribution | ||
| SPT-2403SMSCS | In distribution | ||
| MDT012091L | In distribution | ||
| SPT-2801CS | In distribution | ||
| SYN7443L | In distribution | ||
| DYNJP2501 | In distribution | ||
| DYNJP2373P | XXL | In distribution | |
| SYNDECONL | In distribution | ||
| MDTAUS090XL | 12 | In distribution | |
| MDTZ1196903E | 12 | In distribution | |
| MDT012062XL | 12 | In distribution | |
| DYNJP2401G | In distribution | ||
| SYN7442M | In distribution | ||
| SYN7405XXL | In distribution | ||
| 606MJSL | In distribution | ||
| DYNJP2601 | L | In distribution | |
| MDTZ1057454DB | In distribution | ||
| MDT012091L | 12 | In distribution | |
| DYNJP2809 | 2XL | In distribution | |
| DYNJP2378P | XXL | In distribution | |
| DYNJP2203 | In distribution | ||
| SPT-2725CS | In distribution | ||
| SYN7441S | In distribution | ||
| MDTL1008965A | 12 | In distribution | |
| SYN7403L | In distribution | ||
| DYNJP2726 | 2XL | In distribution | |
| SPT-2402SMSCS | In distribution | ||
| DYNJP2228S | In distribution | ||
| MDTZ1000893AI | In distribution | ||
| DYNJP2103S | 2XL | In distribution | |
| DYNJP2304 | In distribution | ||
| DYNJP2707 | L | In distribution | |
| MDT012085L | 12 | In distribution | |
| MDTAUS062L | 12 | In distribution | |
| DYNJP2228SG | In distribution | ||
| DYNJP2009 | In distribution | ||
| SPT-2227SMSCS | In distribution | ||
| MDT012062L | In distribution | ||
| DYNJP2402G | In distribution | ||
| SYN7401S | In distribution | ||
| DYNJP2201 | L | In distribution | |
| DYNJP2014C | In distribution | ||
| SPT-2003CS | 100 | In distribution | |
| MDTZ1015098AI | In distribution | ||
| DYNJP2807 | L | In distribution | |
| MDT012092XXL | In distribution | ||
| SPT-2202CS | Extra Large | 100 | In distribution |
| MDTZ1001605BC | 24 | In distribution | |
| DYNJP2228P | In distribution | ||
| DYNJP2367P | In distribution | ||
| DYNJP2203SG | In distribution | ||
| MDTZ1000893AH | 12 | In distribution | |
| DYNJP2002SL | XL | In distribution | |
| NONLV410 | 10 | In distribution | |
| DYNJP2709 | XXL | In distribution | |
| MDTL1007015KZ | 12 | In distribution | |
| MDTL1018919BP | In distribution | ||
| DYNJP2472P | In distribution | ||
| SPT-2102CS | In distribution | ||
| SPT-2303PCS | In distribution | ||
| 11105 | 60 | In distribution | |
| MDT012086XL | In distribution | ||
| DYNJP2805 | XL | In distribution | |
| MDT012086L | In distribution | ||
| DYNJP2004S | 3XL | In distribution | |
| MDTZ1024488BA | 12 | In distribution | |
| DYNJP2206 | In distribution | ||
| SPT-2803CS | In distribution | ||
| MDTL1058365AS | 12 | In distribution | |
| SPT-2001CS | 100 | In distribution | |
| MDTAUS086L | In distribution | ||
| DYJPEGOSMM | In distribution | ||
| MDT012083S | 12 | In distribution | |
| DYNJP2002S | XL | In distribution | |
| MDTZ1237983AB | In distribution | ||
| DYJPEGOECM | In distribution | ||
| DYNJP2361P | In distribution | ||
| 16836NS | In distribution | ||
| DYNJP2461P | In distribution | ||
| PINK2003S | In distribution | ||
| DYNJP2502 | XL | In distribution | |
| MDTZ1190144BB | 12 | In distribution | |
| MDTL1018919BA | In distribution | ||
| DYNJP2467P | In distribution | ||
| SPT-2207CS | In distribution | ||
| 16835NS | In distribution | ||
| DYNJP2202 | In distribution | ||
| 33707P | In distribution | ||
| MDT012091XXL | 12 | In distribution | |
| DYNJP2903T | In distribution | ||
| MDTL1081210B | In distribution | ||
| MDTL1008965A | In distribution | ||
| SPT-2377PCS | 100 | In distribution | |
| 16896NS | In distribution | ||
| MDT012080XL | 12 | In distribution | |
| SPT-2208SMSCS | Extra Large | 100 | In distribution |
| DYNJP2000A | In distribution | ||
| DYNJP2478P | In distribution | ||
| DYNJP2308P | In distribution | ||
| DYNJP2202S | XL | In distribution | |
| DYNJP2302P | In distribution | ||
| DYNJP2208 | In distribution | ||
| SPT-2503SMSCS | 100 | In distribution | |
| MDTZ1004222AA | In distribution | ||
| MDTZ1001605BA | In distribution | ||
| DYNJP2603 | 2XL | In distribution | |
| SYNDECON2XL | In distribution | ||
| SIR-2002CS | In distribution | ||
| SPT-2002CSG | 912 | In distribution | |
| DYNJP6000 | In distribution | ||
| DYNJP2806 | 2XL | In distribution | |
| SPT-2207SMSCS | 100 | In distribution | |
| MDTL1023478P | In distribution | ||
| DYNJP2503 | 2XL | In distribution | |
| MDTL1011681BK | In distribution | ||
| MDTZ1310392AA | 12 | In distribution | |
| MDTL1018919BO | In distribution | ||
| DYNJP2001 | L | In distribution | |
| DYNJP2205 | In distribution | ||
| DYNJP2208S | In distribution | ||
| DYNJP2219SL | 3XL | In distribution | |
| NONLV410XXL | 10 | In distribution | |
| DYNJP2468P | In distribution | ||
| MDTZ1004222AA | 12 | In distribution | |
| NONLV410XL | 10 | In distribution | |
| 33709P | In distribution | ||
| SPT-2001SMSCS | In distribution | ||
| DYNJP2206SG | In distribution | ||
| DYNJP2212P | In distribution | ||
| MDTAUS086L | 12 | In distribution | |
| DYNJP2206S | XXL | In distribution | |
| MDT012084XL | In distribution | ||
| DYNJP2219SLG | In distribution | ||
| DYNJP2801 | L | In distribution | |
| MDT012092XL | 12 | In distribution | |
| DYNJP2303P | In distribution | ||
| SIR-2601CS | In distribution | ||
| SRI7000XL | In distribution | ||
| SIR-4002BNSE | 480 | In distribution | |
| MDTZ1237983AA | In distribution | ||
| 21394PCS | In distribution | ||
| ECO3101 | In distribution | ||
| DYNJP2729 | In distribution | ||
| MDT012083XL | In distribution | ||
| SPT2002SMSCSG | In distribution | ||
| MDTL1055621P | 12 | In distribution | |
| DYNJP2005S | S/M | In distribution | |
| SPT-2701CSG | 504 | In distribution | |
| DYNJP2301P | In distribution | ||
| MDTZ1190144BB | In distribution | ||
| SPT-2601SMSCS | In distribution | ||
| DYNJP2379P | 4XL | In distribution | |
| SPT-4003CSGE | 400 | In distribution | |
| DYNJP2003S | 2XL | In distribution | |
| DYNJP2209P | In distribution | ||
| 19310PCS | In distribution | ||
| SYN7404XL | In distribution | ||
| SPT-2804CS | In distribution | ||
| MDT012083L | 12 | In distribution | |
| 606MJSS | In distribution | ||
| DYNJP2708 | XL | In distribution | |
| MDT012090L | 12 | In distribution | |
| MDTZ1237983AB | 12 | In distribution | |
| 606MJSXXL | In distribution | ||
| DYNJP2479P | In distribution | ||
| SPT-2602SMSCS | In distribution | ||
| MDTL1023592AY | In distribution | ||
| SPT-2703CS | In distribution | ||
| DYNJP2019C | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 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 |
| 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
4 recalls name this product by its own identifiers, the UDI on its label or the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Medline Industries, LP – Northfield | 510(k) number | 2026-01-28 | Class II | Labeling Change Control | Fabric may experience premature delamination when using included laundering instructions. Identifying delaminated gown or drape in a surgical setting may result in brief delay in patient care. If delaminated product is used and surgical str | 104,004 |
| 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 |
| Medline Industries, LP – Northfield | UDI-DI | 2023-11-29 | Class II | Process control | Surgical gowns were manufactured with the wrong sleeve. | 2,100 gowns |
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.