The following data is part of a premarket notification filed by Darchet (usa), Inc. with the FDA for Leedar (patient Examination Gloves - Latex).
| Device ID | K891663 |
| 510k Number | K891663 |
| Device Name: | LEEDAR (PATIENT EXAMINATION GLOVES - LATEX) |
| Classification | Latex Patient Examination Glove |
| Applicant | DARCHET (USA), INC. 2425 S. GARFIELD AVE. #108 Monterey Park, CA 91754 |
| Contact | Henry Chuang |
| Correspondent | Henry Chuang DARCHET (USA), INC. 2425 S. GARFIELD AVE. #108 Monterey Park, CA 91754 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-03-20 |
| Decision Date | 1990-02-13 |