Skin-Prep 4oz Spray US
Protective Spray
41manufacturers in China registered for this device type
1catalogue number
1recall
Who Else Makes It
Concentrated in Jiangsu (11), Zhejiang (9), Hubei (6). 7 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 |
| Hubei V-Medical Products Co., Ltd. | Xiantao | Hubei | Contract manufacturer | 46 |
| Planet (Anhui) Medical Products Co., Ltd. | Chuzhou | Anhui | Contract manufacturer | 30 |
| Nanjing Anjian Medical Device Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 22 |
| Tops Medical Articles Industries Nantong Inc | Qidong | Jiangsu | Contract manufacturer | 17 |
| Roosin Medical Co., Ltd. | Taizhou | Jiangsu | Contract manufacturer | 9 |
| Winner Medical (Jiayu) Co., Ltd. | Jiayu | Hubei | Contract manufacturer | 7 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Hospital & Homecare IMP. & EXP. Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 179 |
| Planet(Shanghai) International Co., Ltd. | Shanghai | Shanghai | Exporter | 93 |
| Planet (Anhui) International Co., Ltd. | Chuzhou | Anhui | Exporter | 80 |
| Hubei Qianjiang Kingphar Medical Material Co., Ltd. | Qianjiang | Hubei | Contract manufacturer | 52 |
Showing 12 of 41. All 41 manufacturers in China registered for Bandage, Liquid, Skin Protectant
Record
| Listed by | Smith & Nephew, Inc., United States |
|---|---|
| FDA product code | NEC |
| Device type | Bandage, Liquid, Skin Protectant |
| Device class | Class 1 |
| Regulation | 21 CFR 880.5090 |
| Establishment | Contract manufacturer, Remanufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2020-09-04 |
| Record revised | 2023-09-07 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Over the counter | Yes |
| Label carries | lot or batch number, expiry date |
| Packaging | Case of 12 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 420200 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Coloplast | Coloplast A/S | 8 |
| Avaline Medical NJ LLC | Avaline Medical NJ Limited Liability Company | 8 |
| Medline | Medline Industries, Inc. | 8 |
| Cutimed® | BSN Medical, Inc. | 6 |
| ProCure | Twin Med, LLC | 5 |
| Halyard | Owens & Minor Distribution, Inc. | 4 |
| Brava | Coloplast A/S | 4 |
| ViveCare | Vive Health LLC | 3 |
| Aplicare | Medline Industries, Inc. | 3 |
| SEA-Clens | Coloplast A/S | 2 |
| Durma+ Unna Boot Bandage with Zinc Oxide | Dynarex Corp. | 2 |
| Activon Manuka Honey Barrier Cream | Brightwake Ltd | 2 |
Showing 12 of 58. All products under Bandage, Liquid, Skin Protectant
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2011-04-04 | Not classified | Material/Component Contamination | Smith & Nephew, Inc., St. Petersburg, FL is recalling multiple lot numbers of the following products: REMOVE Universal Adhesive Remover Wipes, UNI-SOLVE Adhesive Remover Wipes, SKIN-PREP Protective Wipes, PERI-PREP Protective Wipes, and NO | 691,225 Boxes of 50 count | 2011-07-18 |
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.