The following data is part of a premarket notification filed by Shen Wei (usa), Inc. with the FDA for Powder-free Synthetic Vinyl Exam Gloves With Vitamin E Coating.
| Device ID | K051683 |
| 510k Number | K051683 |
| Device Name: | POWDER-FREE SYNTHETIC VINYL EXAM GLOVES WITH VITAMIN E COATING |
| Classification | Vinyl Patient Examination Glove |
| Applicant | SHEN WEI (USA), INC. 33278 CENTRAL AVE. #102 Union City, CA 94587 |
| Contact | Stanley Duan |
| Correspondent | Stanley Duan SHEN WEI (USA), INC. 33278 CENTRAL AVE. #102 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 | 2005-06-23 |
| Decision Date | 2005-08-01 |