Supmedic
Nitrile Examination Gloves:KG-1106 (XS size)
2manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Hubei (1), Shaanxi (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Wuhan Landing Intelligence Medical Co., Ltd. | Wuhan | Hubei | Manufacturer | 17 |
| Xian Tianlong Science AND Technology Co., Ltd. | Xi’An | Shaanxi | Manufacturer | 8 |
Record
| Listed by | Supmedics Inc. |
|---|---|
| FDA product code | LEA |
| Device type | Preservative, Cytological |
| Device class | Class 1 |
| Regulation | 21 CFR 864.4010 |
| 510(k) | K221887 |
| Record published | 2024-11-04 |
| Record revised | 2025-02-07 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Over the counter | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Handling environment temperature up to 40 °C |
| Packaging | Carton of 10 |
| Sizes | Width 70 mm |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| SKF3301 | Width 70 mm | 100 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Epredia | Richard-Allan Scientific LLC | 28 |
| PathTezt® | Biocytech Corporation SDN BHD | 17 |
| ThinPrep | Hologic, Inc. | 12 |
| Streck Cell Preservative | Streck LLC | 4 |
| Leica Biosystems | Leica Biosystems Richmond, Inc. | 2 |
| BD CytoRich™ Clear Preservative | Becton, Dickinson AND Company | 1 |
| MES: Freeze Medium | Lonza Walkersville, Inc. | 1 |
| Pre-prcs Prtm Frz Sol 131P0103, 50L drum | Lonza Walkersville, Inc. | 1 |
| Fisherbrand | Fisher Scientific Company L.L.C. | 1 |
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.