The following data is part of a premarket notification filed by Shen Wei (usa), Inc. with the FDA for Powder-free Latex Examination Gloves.
| Device ID | K935812 |
| 510k Number | K935812 |
| Device Name: | POWDER-FREE LATEX EXAMINATION GLOVES |
| Classification | Latex Patient Examination Glove |
| Applicant | SHEN WEI (USA), INC. 1163 CHESS DRIVE, SUITE D Foster City, CA 94404 |
| Contact | Willis L.u. Chou |
| Correspondent | Willis L.u. Chou SHEN WEI (USA), INC. 1163 CHESS DRIVE, SUITE D Foster City, CA 94404 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-12-02 |
| Decision Date | 1994-03-23 |