The following data is part of a premarket notification filed by Shen Wei (usa), Inc. with the FDA for Pearlescent Powder Free Nitrile Examination Gloves With Aloe Vera (yellow, Red, Green, Black, Blue).
| Device ID | K092411 |
| 510k Number | K092411 |
| Device Name: | PEARLESCENT POWDER FREE NITRILE EXAMINATION GLOVES WITH ALOE VERA (YELLOW, RED, GREEN, BLACK, BLUE) |
| Classification | Polymer Patient Examination Glove |
| Applicant | SHEN WEI (USA), INC. 33278 CENTRAL AVE., SUITE 102 Union City, CA 94587 |
| Contact | Albert Li |
| Correspondent | Albert Li 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 | 2009-08-07 |
| Decision Date | 2009-10-21 |