The following data is part of a premarket notification filed by Fadr Intl., Inc. with the FDA for Patient Examination Gloves (latex).
| Device ID | K892621 |
| 510k Number | K892621 |
| Device Name: | PATIENT EXAMINATION GLOVES (LATEX) |
| Classification | Latex Patient Examination Glove |
| Applicant | FADR INTL., INC. 9831 ROMANDEL AVE. Santa Fe Springs, CA 90670 |
| Contact | James Fan |
| Correspondent | James Fan FADR INTL., INC. 9831 ROMANDEL AVE. Santa Fe Springs, CA 90670 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-04-07 |
| Decision Date | 1989-06-02 |