No-Sting Skin-Prep Swabs 3ml
No-sting protective swab
3manufacturers in China registered for this device type
1catalogue number
2510(k) clearances naming this product code
1recall
Who Else Makes It
Concentrated in Guangdong (2), Jiangsu (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Derma Sciences Nantong Incorporation | Development | Jiangsu | Contract manufacturer | 19 |
| Huizhou Foryou Medical Devices Co., Ltd. | Huizhou | Guangdong | Contract manufacturer | 18 |
| Shenzhen JPY ION-Tech. Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 20 |
Record
| Listed by | Smith & Nephew, Inc., United States |
|---|---|
| FDA product code | KMF |
| Device type | Bandage, Liquid |
| Device class | Class 1 |
| Regulation | 21 CFR 880.5090 |
| Establishment | Contract manufacturer, Remanufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2021-02-10 |
| Record revised | 2023-09-07 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Over the counter | Yes |
| Label carries | lot or batch number, expiry date |
| Packaging | Carton of 50, case of 12 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 59420700 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| PolyMem | Ferris MFG. Corp. | 60 |
| 3M™ Cavilon™ | 3M Company | 54 |
| Kendall | Cardinal Health | 23 |
| Kendall | Cardinal Health 200, LLC | 15 |
| Curity | Cardinal Health | 11 |
| GluSeal® | Glustich Inc | 7 |
| Stratis | Covidien LP | 7 |
| Curity | Cardinal Health 200, LLC | 6 |
| Tritis | Covidien LP | 4 |
| GluSeal®90 | Glustich Inc | 3 |
| Medline | Medline Industries, Inc. | 3 |
| GluSeal®90 | Skinstitch Corp. | 2 |
Showing 12 of 29. All products under Bandage, Liquid
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K983210 | 1998-12-10 |
| K973228 | 1997-11-25 |
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 | 108490 cartons (471800 wipes); 192,945(kits containing wipes | 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.