Novo Health Services, LLC
L3 Enhanced SLV MED W/Paper TWL
68manufacturers in China registered for this device type
222catalogue numbers in this listing
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 | Novo Health Services, LLC |
|---|---|
| FDA product code | FYA |
| Device type | Gown, Surgical |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4040 |
| 510(k) | K031933 |
| Record published | 2019-06-28 |
| Record revised | 2022-10-21 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date, serial number |
| Sizes | Weight 0.5 to 27.8 lb; width 2 to 23 in; height 1 to 19 in |
| Distribution end date | 2026-05-10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 8001 | Weight 4.1 lb | In distribution |
| 123694 | In distribution | |
| 433000 | Weight 0.8 lb | In distribution |
| 541000 | Weight 19.4 lb | In distribution |
| 8503 | Weight 5.2 lb | In distribution |
| 1152 | Weight 0.8 lb | In distribution |
| 622000 | Weight 1.2 lb | In distribution |
| 127126 | Weight 15.3 lb | In distribution |
| 8004 | Weight 6.7 lb | In distribution |
| 123696 | Weight 20.3 lb | In distribution |
| 8505 | Weight 8 lb | In distribution |
| 131015 | Weight 1.5 lb | In distribution |
| 1079 | Weight 0.9 lb | In distribution |
| 534000 | Weight 0.5 lb | In distribution |
| 127128 | Weight 22.5 lb | In distribution |
| 1583 | In distribution | |
| 413000 | Weight 1.0 lb | In distribution |
| 1579 | Weight 1.3 lb | In distribution |
| 1080 | Weight 1.0 lb | In distribution |
| 127125 | Height 5 in | In distribution |
| 131010 | Weight 1.6 lb | In distribution |
| 131008 | Weight 1.2 lb | In distribution |
| 8002 | Weight 4.3 lb | In distribution |
| 8504 | Weight 5 lb | In distribution |
| 123706 | Weight 22.5 lb | In distribution |
| 665300 | Weight 5 lb | In distribution |
| 123256 | Weight 4.4 lb | In distribution |
| 1580 | Weight 1.4 lb | In distribution |
| 635000 | Weight 1.2 lb | In distribution |
| 151000 | Weight 0.9 lb | In distribution |
| 532000 | Weight 0.7 lb | In distribution |
| 123341 | Weight 9.0 lb | In distribution |
| 435000 | Weight 1.0 lb | In distribution |
| 624000 | Weight 1.3 lb | In distribution |
| 524000 | Weight 1.4 lb | In distribution |
| 8003 | Weight 5.8 lb | In distribution |
| 129074 | In distribution | |
| 123697 | Weight 20.3 lb | In distribution |
| 1578 | Weight 0.8 lb | In distribution |
| 625000 | Weight 1.7 lb | In distribution |
| 724000 | Weight 1.2 lb | In distribution |
| 123743 | Weight 19.1 lb | In distribution |
| 642000 | Height 12 in | In distribution |
| 640000 | Height 11 in | In distribution |
| 8502 | Weight 3.7 lb | In distribution |
| 131006 | Weight 0.9 lb | In distribution |
| 623000 | Weight 1.2 lb | In distribution |
| 131012 | Weight 1.0 lb | In distribution |
| 131013 | Weight 0.9 lb | In distribution |
| 525000 | Weight 1 lb | In distribution |
| 131009 | Weight 1.4 lb | In distribution |
| 131018 | Weight 5.3 lb | In distribution |
| 1154 | Weight 1.1 lb | In distribution |
| 434000 | Weight 1.0 lb | In distribution |
| 523000 | Weight 0.9 lb | In distribution |
| 542000 | Weight 17.7 lb | In distribution |
| 1083 | Weight 2.0 lb | In distribution |
| 634000 | Weight 1.1 lb | In distribution |
| 126265 | Weight 1.9 lb | In distribution |
| 131014 | Weight 1.3 lb | In distribution |
| 127127 | Height 7 in | In distribution |
| 129075 | In distribution | |
| 129026 | In distribution | |
| 665200 | Height 6 in | In distribution |
| 533000 | Weight 0.7 lb | In distribution |
| 665100 | Weight 3.8 lb | In distribution |
| 641000 | Weight 21.0 lb | In distribution |
| 535000 | Weight 1 lb | In distribution |
| 1653 | Weight 1.3 lb | In distribution |
| 1085 | Weight 1.6 lb | In distribution |
| 129061 | In distribution | |
| 1153 | Weight 1.0 lb | In distribution |
| 124173 | Weight 3.9 lb | In distribution |
| 1155 | Weight 1.3 lb | In distribution |
| 129062 | In distribution | |
| 1581 | Weight 1.5 lb | In distribution |
| 123698 | Weight 17.7 lb | In distribution |
| 1654 | Weight 1.5 lb | In distribution |
| 633000 | Weight 0.9 lb | In distribution |
| 123255 | Weight 4.0 lb | In distribution |
| 127218 | Weight 1.8 lb | In distribution |
| 522000 | Weight 0.8 lb | In distribution |
| 665400 | Height 9 in | In distribution |
| 8005 | Weight 6.3 lb | In distribution |
| 1081 | Width 6.5 in | In distribution |
| 123695 | Weight 21.9 lb | In distribution |
| 129051 | Withdrawn | |
| 722000 | Weight 0.8 lb | Withdrawn |
| 8501 | Weight 3.0 lb | Withdrawn |
| 120652 | Weight 1.7 lb | Withdrawn |
| 131007 | Weight 1 lb | Withdrawn |
| 1655 | Weight 1.5 lb | Withdrawn |
| 123648 | Weight 27.8 lb | Withdrawn |
| 131017 | Withdrawn | |
| 121317 | Weight 8.9 lb | Withdrawn |
| 823000 | Weight 1.2 lb | Withdrawn |
| 574000 | Weight 5.0 lb | Withdrawn |
| 131019 | Weight 2.0 lb | Withdrawn |
| 123744 | Weight 16.5 lb | Withdrawn |
| 151003 | Weight 1.0 lb | Withdrawn |
| 8505 | Weight 8 lb | Withdrawn |
| 129066 | Withdrawn | |
| 120655 | Weight 1.9 lb | Withdrawn |
| 1579 | Weight 1.3 lb | Withdrawn |
| 832000 | Weight 0.8 lb | Withdrawn |
| 1151 | Weight 0.9 lb | Withdrawn |
| 6701 | Weight 4.7 lb | Withdrawn |
| 1578 | Weight 0.8 lb | Withdrawn |
| 123446 | Weight 11.3 lb | Withdrawn |
| 124417 | Weight 1.5 lb | Withdrawn |
| 1521 | Withdrawn | |
| 1165 | Weight 3.1 lb | Withdrawn |
| 1654 | Weight 1.5 lb | Withdrawn |
| 571000 | Weight 3.5 lb | Withdrawn |
| 425000 | Weight 1.0 lb | Withdrawn |
| 124470 | Weight 1.7 lb | Withdrawn |
| 572000 | Withdrawn | |
| 1253 | Weight 1.0 lb | Withdrawn |
| 1703 | Weight 1.1 lb | Withdrawn |
| 129063 | Withdrawn | |
| 733000 | Weight 1.0 lb | Withdrawn |
| 126084 | Height 8 in | Withdrawn |
| 8502 | Weight 3.7 lb | Withdrawn |
| 129036 | Withdrawn | |
| 127293 | Weight 10.1 lb | Withdrawn |
| 573000 | Withdrawn | |
| 1577 | Height 2 in | Withdrawn |
| 126267 | Weight 2.8 lb | Withdrawn |
| 129038 | Withdrawn | |
| 1159 | Weight 1.9 lb | Withdrawn |
| 124952 | Weight 4 lb | Withdrawn |
| 101652 | Weight 1.1 lb | Withdrawn |
| 120684 | Weight 4 lb | Withdrawn |
| 126266 | Weight 2.5 lb | Withdrawn |
| 732000 | Weight 0.7 lb | Withdrawn |
| 127154 | Weight 2.3 lb | Withdrawn |
| 424000 | Height 2 in | Withdrawn |
| 120786 | Weight 3.2 lb | Withdrawn |
| 127724 | Weight 4.4 lb | Withdrawn |
| 734000 | Weight 1.1 lb | Withdrawn |
| 834000 | Weight 1.3 lb | Withdrawn |
| 8504 | Weight 5 lb | Withdrawn |
| 126115 | Weight 0.9 lb | Withdrawn |
| 127360 | Weight 8.6 lb | Withdrawn |
| 129056 | Withdrawn | |
| 8603 | Withdrawn | |
| 151001 | Weight 0.8 lb | Withdrawn |
| 7146 | Weight 3.5 lb | Withdrawn |
| 129052 | Withdrawn | |
| 8604 | Withdrawn | |
| 129067 | Withdrawn | |
| 129039 | Withdrawn | |
| 123696 | Weight 20.3 lb | Withdrawn |
| 126114 | Weight 0.8 lb | Withdrawn |
| 129068 | Withdrawn | |
| 120756 | Weight 5.7 lb | Withdrawn |
| 1653 | Weight 1.3 lb | Withdrawn |
| 129035 | Withdrawn | |
| 1659 | Weight 2.5 lb | Withdrawn |
| 123441 | Weight 9.9 lb | Withdrawn |
| 1581 | Weight 1.5 lb | Withdrawn |
| 415000 | Weight 1.2 lb | Withdrawn |
| 422000 | Weight 0.9 lb | Withdrawn |
| 1509 | Weight 2.8 lb | Withdrawn |
| 1004 | Weight 1.6 lb | Withdrawn |
| 1078 | Weight 1.0 lb | Withdrawn |
| 127338 | Weight 4.6 lb | Withdrawn |
| 432000 | Width 7 in | Withdrawn |
| 129037 | Withdrawn | |
| 423000 | Width 7 in | Withdrawn |
| 131020 | Weight 4.2 lb | Withdrawn |
| 833000 | Weight 1.1 lb | Withdrawn |
| 127294 | Weight 10.1 lb | Withdrawn |
| 825000 | Weight 1.5 lb | Withdrawn |
| 1652 | Weight 1.1 lb | Withdrawn |
| 1580 | Weight 1.4 lb | Withdrawn |
| 129069 | Withdrawn | |
| 1255 | Weight 1.1 lb | Withdrawn |
| 860001 | Weight 10.7 lb | Withdrawn |
| 123745 | Weight 19.2 lb | Withdrawn |
| 835000 | Weight 1.5 lb | Withdrawn |
| 1167 | Weight 2.3 lb | Withdrawn |
| 735000 | Weight 1.3 lb | Withdrawn |
| 121097 | Withdrawn | |
| 123700 | Weight 19.4 lb | Withdrawn |
| 540000 | Weight 16.5 lb | Withdrawn |
| 127582 | Weight 1.5 lb | Withdrawn |
| 127218 | Weight 1.8 lb | Withdrawn |
| 129073 | Withdrawn | |
| 1254 | Weight 1.0 lb | Withdrawn |
| 123581 | Weight 8.1 lb | Withdrawn |
| 129040 | Withdrawn | |
| 126285 | Weight 3.6 lb | Withdrawn |
| 6026 | Weight 3.2 lb | Withdrawn |
| 8503 | Weight 5.2 lb | Withdrawn |
| 1158 | Weight 1.8 lb | Withdrawn |
| 129072 | Withdrawn | |
| 121951 | Weight 1.8 lb | Withdrawn |
| 6559 | Weight 3.4 lb | Withdrawn |
| 126113 | Weight 0.7 lb | Withdrawn |
| 824000 | Weight 1.4 lb | Withdrawn |
| 121098 | Withdrawn | |
| 127580 | Weight 0.9 lb | Withdrawn |
| 6137 | Weight 6.6 lb | Withdrawn |
| 121248 | Height 7 in | Withdrawn |
| 123697 | Weight 20.3 lb | Withdrawn |
| 1701 | Weight 1.1 lb | Withdrawn |
| 124206 | Weight 4.1 lb | Withdrawn |
| 822000 | Weight 0.9 lb | Withdrawn |
| 121749 | Weight 6.4 lb | Withdrawn |
| 1016 | Weight 3.8 lb | Withdrawn |
| 632000 | Weight 0.8 lb | Withdrawn |
| 129026 | Withdrawn | |
| 124012 | Weight 27.0 lb | Withdrawn |
| 124416 | Weight 1.3 lb | Withdrawn |
| 123687 | Weight 6.5 lb | Withdrawn |
| 127500 | Height 5 in | Withdrawn |
| 723000 | Weight 1.0 lb | Withdrawn |
| 1705 | Weight 1.9 lb | Withdrawn |
| 127581 | Weight 1.1 lb | Withdrawn |
| 725000 | Weight 1.3 lb | Withdrawn |
| 151002 | Weight 0.9 lb | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Medline | Medline Industries, Inc. | 453 |
| Halyard | O&M Halyard, Inc. | 248 |
| 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
Recalls Naming This Product
1 recall names this product by its own identifier, 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 |
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.