The following data is part of a premarket notification filed by Associated Ent., Inc. with the FDA for Bud Brand Patient Examination Gloves (vinyl).
| Device ID | K891835 |
| 510k Number | K891835 |
| Device Name: | BUD BRAND PATIENT EXAMINATION GLOVES (VINYL) |
| Classification | Vinyl Patient Examination Glove |
| Applicant | ASSOCIATED ENT., INC. P.O. BOX 1925 Danville, CA 94526 -6925 |
| Contact | C. W Chan,phd |
| Correspondent | C. W Chan,phd ASSOCIATED ENT., INC. P.O. BOX 1925 Danville, CA 94526 -6925 |
| Product Code | LYZ |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-03-27 |
| Decision Date | 1989-06-22 |