Novo Health Services, LLC
Level 2, STD Gown, XXLarge with towel
172manufacturers in China registered for this device type
172catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (45), Zhejiang (30), Shanghai (20). 34 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai Joy Crown Industry Co., Ltd. | Pu Dong New Area | Shanghai | Contract manufacturer | 64 |
| Principle & Will Biotech (Pinghu) Co., Ltd. | Pinghu | Zhejiang | Contract manufacturer | 39 |
| Taizhou Xinkang Medical Materials Co., Ltd. | Taizhou | Jiangsu | Contract manufacturer | 35 |
| Jiangsu Guangda Medical Material Group Co., Ltd. | Haian | Jiangsu | Contract manufacturer | 32 |
| Dongguan Shin YI Healthcare Products Factory | Dong Guan | Guangdong | Contract manufacturer | 30 |
| Jinhua Jingdi Medical Supplies Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 29 |
| Jinhua Ivy Home Textile Co., Limited | Jinhua | Zhejiang | Contract manufacturer | 18 |
| Sino Protection (Hefei) Medical Products Co., Ltd. | Hefei | Anhui | Contract manufacturer | 18 |
| Kingstar Medical (Xianning) Co., Ltd. | Xianning | Hubei | Contract manufacturer | 17 |
| Ming FAI Industrial (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 17 |
| Xiantao Daoqi Plastic Co., Ltd. | Xiantao | Hubei | Contract manufacturer | 16 |
| Lianyungang Bronson Non-woven Products Co., Ltd. | Lianyungang | Jiangsu | Contract manufacturer | 16 |
Showing 12 of 172. All 172 manufacturers in China registered for Fiber, Medical, Absorbent
Record
| Listed by | Novo Health Services, LLC |
|---|---|
| FDA product code | FRL |
| Device type | Fiber, Medical, Absorbent |
| Device class | Class 1 |
| Regulation | 21 CFR 880.5300 |
| 510(k) | K982694 |
| Record published | 2020-03-13 |
| Record revised | 2020-03-11 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, manufacturing date, serial number |
| Sizes | Weight 0.1 to 19.3 lb; width 4.75 to 23 in; height 0.5 to 23 in |
| Distribution end date | 2026-05-10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 129048 | In distribution | |
| 2314 | Weight 2.0 lb | In distribution |
| 2112 | Weight 2.3 lb | In distribution |
| 127563 | Weight 13.6 lb | In distribution |
| 127993 | Weight 0.2 lb | In distribution |
| 6873 | Height 0.5 in | In distribution |
| 125010 | Weight 5 lb | In distribution |
| 5973 | Height 12 in | In distribution |
| 2130 | Weight 5.9 lb | In distribution |
| 6402 | Weight 1.3 lb | In distribution |
| 2104 | Weight 0.7 lb | In distribution |
| 122233 | Weight 7.2 lb | In distribution |
| 2204 | Weight 1.0 lb | In distribution |
| 121234 | Weight 2 lb | In distribution |
| 121046 | Weight 9.4 lb | In distribution |
| 0025 | Weight 3.9 lb | In distribution |
| 120755 | Weight 2.3 lb | In distribution |
| 127990 | Weight 2.7 lb | In distribution |
| 0127 | Height 3.2 in | In distribution |
| 127503 | Weight 0.9 lb | In distribution |
| 0027 | Weight 3.9 lb | In distribution |
| 0026 | In distribution | |
| 2205 | Weight 1.1 lb | In distribution |
| 120754 | Weight 4.2 lb | In distribution |
| 2070 | Weight 0.4 lb | In distribution |
| 126111 | Weight 9.5 lb | In distribution |
| 2108 | Weight 1.3 lb | In distribution |
| 127994 | Weight 0.9 lb | In distribution |
| 2102 | Weight 0.4 lb | In distribution |
| 414000 | Height 2 in | In distribution |
| 121775 | Weight 0.5 lb | In distribution |
| 123682 | Weight 8.1 lb | In distribution |
| 121077 | Weight 3.3 lb | In distribution |
| 0035 | Weight 3.3 lb | In distribution |
| 127504 | Weight 1.3 lb | In distribution |
| 127995 | Weight 19.3 lb | In distribution |
| 2106 | Weight 1 lb | In distribution |
| 123986 | Weight 7.9 lb | In distribution |
| 6543 | Weight 0.2 lb | In distribution |
| 120455 | Weight 0.6 lb | In distribution |
| 123683 | Weight 0.8 lb | In distribution |
| 127885 | Weight 2.6 lb | In distribution |
| 6830 | Weight 0.4 lb | In distribution |
| 120154 | Weight 0.3 lb | In distribution |
| 127401 | Weight 0.2 lb | Withdrawn |
| 126061 | Weight 1.7 lb | Withdrawn |
| 2105 | Weight 0.9 lb | Withdrawn |
| 129070 | Withdrawn | |
| 2110 | Weight 2.0 lb | Withdrawn |
| 613000 | Weight 1.1 lb | Withdrawn |
| 0022 | Withdrawn | |
| 2132 | Weight 4.7 lb | Withdrawn |
| 814000 | Weight 1.5 lb | Withdrawn |
| 120176 | Height 1.5 in | Withdrawn |
| 1003 | Weight 1.3 lb | Withdrawn |
| 101002 | Weight 1.2 lb | Withdrawn |
| 2121 | Weight 3.9 lb | Withdrawn |
| 135003 | Weight 1.0 lb | Withdrawn |
| 2116 | Weight 3.0 lb | Withdrawn |
| 127404 | Weight 7.3 lb | Withdrawn |
| 1203 | Weight 1.1 lb | Withdrawn |
| 2126 | Weight 7.2 lb | Withdrawn |
| 123650 | Weight 3.3 lb | Withdrawn |
| 0023 | Withdrawn | |
| 101005 | Weight 1.6 lb | Withdrawn |
| 101009 | Weight 2.6 lb | Withdrawn |
| 715000 | Weight 1.5 lb | Withdrawn |
| 1005 | Weight 1.7 lb | Withdrawn |
| 126151 | Weight 0.6 lb | Withdrawn |
| 131003 | Weight 1.3 lb | Withdrawn |
| 101003 | Width 7 in | Withdrawn |
| 131021 | Weight 3.0 lb | Withdrawn |
| 2084 | Weight 2.0 lb | Withdrawn |
| 131001 | Weight 1.2 lb | Withdrawn |
| 123625 | Weight 0.7 lb | Withdrawn |
| 2808 | Weight 1.5 lb | Withdrawn |
| 1502 | Weight 1.3 lb | Withdrawn |
| 6071 | Weight 0.9 lb | Withdrawn |
| 0028 | Withdrawn | |
| 2083 | Weight 1.3 lb | Withdrawn |
| 1008 | Weight 1.9 lb | Withdrawn |
| 120459 | Weight 2.1 lb | Withdrawn |
| 1010 | Width 8.5 in | Withdrawn |
| 2802 | Weight 0.4 lb | Withdrawn |
| 1205 | Weight 1.7 lb | Withdrawn |
| 2812 | Weight 2.3 lb | Withdrawn |
| 815000 | Weight 1.7 lb | Withdrawn |
| 512000 | Weight 0.9 lb | Withdrawn |
| 1021 | Weight 4.7 lb | Withdrawn |
| 860002 | Weight 10.0 lb | Withdrawn |
| 1503 | Weight 1.1 lb | Withdrawn |
| 135004 | Weight 1.5 lb | Withdrawn |
| 170001 | Weight 1.6 lb | Withdrawn |
| 170000 | Weight 1.3 lb | Withdrawn |
| 652000 | Weight 2.2 lb | Withdrawn |
| 123439 | Weight 1.6 lb | Withdrawn |
| 2806 | Weight 1.2 lb | Withdrawn |
| 170003 | Weight 1.5 lb | Withdrawn |
| 1001 | Weight 1.1 lb | Withdrawn |
| 513000 | Weight 1 lb | Withdrawn |
| 1849 | Withdrawn | |
| 2804 | Weight 0.8 lb | Withdrawn |
| 102104 | Weight 0.9 lb | Withdrawn |
| 131002 | Weight 1.6 lb | Withdrawn |
| 2133 | Weight 4.3 lb | Withdrawn |
| 101505 | Weight 1.9 lb | Withdrawn |
| 124967 | Height 9.5 in | Withdrawn |
| 120721 | Weight 1.7 lb | Withdrawn |
| 1201 | Weight 0.9 lb | Withdrawn |
| 1704 | Height 2 in | Withdrawn |
| 135002 | Weight 1.2 lb | Withdrawn |
| 713000 | Weight 1.2 lb | Withdrawn |
| 135005 | Weight 1.6 lb | Withdrawn |
| 1508 | Weight 2.2 lb | Withdrawn |
| 2131 | Weight 5.7 lb | Withdrawn |
| 129027 | Withdrawn | |
| 1501 | Weight 1.1 lb | Withdrawn |
| 615000 | Weight 1.5 lb | Withdrawn |
| 0125 | Withdrawn | |
| 102083 | Weight 1.5 lb | Withdrawn |
| 127282 | Weight 12.6 lb | Withdrawn |
| 6018 | Weight 0.2 lb | Withdrawn |
| 1505 | Weight 1.9 lb | Withdrawn |
| 2310 | Weight 2.3 lb | Withdrawn |
| 2810 | Weight 1.9 lb | Withdrawn |
| 124980 | Weight 9.3 lb | Withdrawn |
| 412000 | Height 2 in | Withdrawn |
| 2313 | Weight 2.0 lb | Withdrawn |
| 2082 | Weight 1.0 lb | Withdrawn |
| 653000 | Weight 3.3 lb | Withdrawn |
| 124098 | Weight 3.8 lb | Withdrawn |
| 120203 | Weight 4.6 lb | Withdrawn |
| 2124 | Weight 4.1 lb | Withdrawn |
| 170002 | Weight 1.7 lb | Withdrawn |
| 1510 | Withdrawn | |
| 2107 | Weight 0.5 lb | Withdrawn |
| 612000 | Weight 1 lb | Withdrawn |
| 123650 | Weight 3.3 lb | Withdrawn |
| 2081 | Weight 0.7 lb | Withdrawn |
| 1002 | Weight 1 lb | Withdrawn |
| 2304 | Weight 1.0 lb | Withdrawn |
| 2085 | Weight 2.3 lb | Withdrawn |
| 1515 | Height 7 in | Withdrawn |
| 127278 | Height 8.5 in | Withdrawn |
| 1009 | Weight 2.5 lb | Withdrawn |
| 514000 | Weight 1.1 lb | Withdrawn |
| 131004 | Weight 1.5 lb | Withdrawn |
| 1204 | Weight 1.5 lb | Withdrawn |
| 120279 | Weight 2.7 lb | Withdrawn |
| 1015 | Weight 3.8 lb | Withdrawn |
| 123443 | Weight 7.8 lb | Withdrawn |
| 555200 | Weight 0.4 lb | Withdrawn |
| 121358 | Weight 6.3 lb | Withdrawn |
| 813000 | Weight 1.3 lb | Withdrawn |
| 102102 | Weight 0.6 lb | Withdrawn |
| 1202 | Weight 1.1 lb | Withdrawn |
| 2123 | Weight 6.7 lb | Withdrawn |
| 2128 | Weight 5.6 lb | Withdrawn |
| 127563 | Weight 13.6 lb | Withdrawn |
| 120176 | Height 1.5 in | Withdrawn |
| 614000 | Weight 1.2 lb | Withdrawn |
| 121095 | Withdrawn | |
| 812000 | Weight 1.0 lb | Withdrawn |
| 515000 | Weight 1.2 lb | Withdrawn |
| 6226 | Weight 0.2 lb | Withdrawn |
| 1702 | Height 3 in | Withdrawn |
| 120716 | Weight 2.2 lb | Withdrawn |
| 131005 | Weight 1.6 lb | Withdrawn |
| 714000 | Weight 1.3 lb | Withdrawn |
| 1504 | Weight 1.6 lb | Withdrawn |
| 124941 | Height 9.5 in | Withdrawn |
| 2129 | Weight 5.6 lb | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Curity | Cardinal Health | 75 |
| DeRoyal | Deroyal Industries, Inc. | 71 |
| Medline | Medline Industries, Inc. | 60 |
| A Plus | A Plus International, Inc | 58 |
| Cardinal Health | Cardinal Health 200, LLC | 47 |
| Bioseal Inc. | Bioseal | 44 |
| Airo™ CPAP Mask Liners | Athfar 828, Inc. | 37 |
| Curity | Cardinal Health 200, LLC | 31 |
| Medical Action / Manus | Medical Action Industries, Inc. | 31 |
| Medical Action Industries | Medical Action Industries, Inc. | 24 |
| Sofsorb OR Towel | Standard Textile Co., Inc. | 22 |
| Towel Perval | Standard Textile Co., Inc. | 19 |
Showing 12 of 148. All products under Fiber, Medical, Absorbent
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.