The following data is part of a premarket notification filed by Shen Wei (usa), Inc. with the FDA for Powder-free Synthetic Vinyl Examination Gloves, Blue Color.
| Device ID | K032084 |
| 510k Number | K032084 |
| Device Name: | POWDER-FREE SYNTHETIC VINYL EXAMINATION GLOVES, BLUE COLOR |
| Classification | Vinyl Patient Examination Glove |
| Applicant | SHEN WEI (USA), INC. 2845 WHIPPLE RD. Union City, CA 94587 |
| Contact | Belle Chou |
| Correspondent | Belle Chou 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 | 2003-07-07 |
| Decision Date | 2003-10-29 |