The following data is part of a premarket notification filed by Shen Wei (usa), Inc. with the FDA for Powder-free Vinyl Examination Gloves.
| Device ID | K033693 |
| 510k Number | K033693 |
| Device Name: | POWDER-FREE VINYL EXAMINATION GLOVES |
| Classification | Vinyl Patient Examination Glove |
| Applicant | SHEN WEI (USA), INC. 2845 WHIPPLE RD. Union City, CA 94587 |
| Contact | Cynthia Liu |
| Correspondent | Cynthia Liu SHEN WEI (USA), INC. 2845 WHIPPLE RD. Union City, CA 94587 |
| Product Code | LYZ |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-11-24 |
| Decision Date | 2004-01-16 |