The following data is part of a premarket notification filed by Shen Wei (usa), Inc. with the FDA for Textured Powder-free Latex Exam Gloves With Aloe Vera And Protein Content Labeling Claim (50 Micrograms Or Less).
| Device ID | K983145 |
| 510k Number | K983145 |
| Device Name: | TEXTURED POWDER-FREE LATEX EXAM GLOVES WITH ALOE VERA AND PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) |
| Classification | Latex Patient Examination Glove |
| Applicant | SHEN WEI (USA), INC. 2845 WHIPPLE RD. Union City, CA 94587 |
| Contact | Belle L Chou |
| Correspondent | Belle L Chou SHEN WEI (USA), INC. 2845 WHIPPLE RD. Union City, CA 94587 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-09-08 |
| Decision Date | 1999-01-26 |