The following data is part of a premarket notification filed by Shen Wei (usa), Inc. with the FDA for Patient Examination Gloves (latex).
| Device ID | K892742 |
| 510k Number | K892742 |
| Device Name: | PATIENT EXAMINATION GLOVES (LATEX) |
| Classification | Latex Patient Examination Glove |
| Applicant | SHEN WEI (USA), INC. 1163 CHESS DRIVE, SUITE D Foster City, CA 94404 |
| Contact | L. U Chou |
| Correspondent | L. U Chou SHEN WEI (USA), INC. 1163 CHESS DRIVE, SUITE D Foster City, CA 94404 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-04-11 |
| Decision Date | 1989-05-25 |