The following data is part of a premarket notification filed by Shen Wei (usa), Inc. with the FDA for Powder- Free Nitrile Examination Gloves, Black Color.
| Device ID | K090194 |
| 510k Number | K090194 |
| Device Name: | POWDER- FREE NITRILE EXAMINATION GLOVES, BLACK COLOR |
| Classification | Polymer Patient Examination Glove |
| Applicant | SHEN WEI (USA), INC. 33278 CENTRAL AVE., SUITE 102 Union City, CA 94587 |
| Contact | Belle Chou |
| Correspondent | Belle Chou SHEN WEI (USA), INC. 33278 CENTRAL AVE., SUITE 102 Union City, CA 94587 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-01-27 |
| Decision Date | 2009-07-07 |