The following data is part of a premarket notification filed by Shen Wei (usa), Inc. with the FDA for Powder Free Butadiene Exam Gloves With Aloe, Green.
| Device ID | K050467 |
| 510k Number | K050467 |
| Device Name: | POWDER FREE BUTADIENE EXAM GLOVES WITH ALOE, GREEN |
| Classification | Polymer Patient Examination Glove |
| Applicant | SHEN WEI (USA), INC. 2845 WHIPPLE RD. Union City, CA 94587 |
| Contact | Cynthia Liu |
| Correspondent | Cynthia Liu SHEN WEI (USA), INC. 2845 WHIPPLE RD. 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 | 2005-02-23 |
| Decision Date | 2005-03-30 |
| Summary: | summary |