The following data is part of a premarket notification filed by Shen Wei (usa), Inc. with the FDA for Pearlescent Powder Free Nitrile Examination Glove With Aloe Vera (yellow, Red, Green, Black, Blue).
| Device ID | K101436 |
| 510k Number | K101436 |
| Device Name: | PEARLESCENT POWDER FREE NITRILE EXAMINATION GLOVE WITH ALOE VERA (YELLOW, RED, GREEN, BLACK, BLUE) |
| Classification | Patient Examination Glove, Specialty |
| Applicant | SHEN WEI (USA), INC. 33278 CENTRAL AVE., SUITE 102 Union City, CA 94587 |
| Contact | Ablert Li |
| Correspondent | Ablert Li SHEN WEI (USA), INC. 33278 CENTRAL AVE., SUITE 102 Union City, CA 94587 |
| Product Code | LZC |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-05-24 |
| Decision Date | 2010-11-17 |
| Summary: | summary |