The following data is part of a premarket notification filed by Ulti-med Intl., Inc. with the FDA for Patient Examination Gloves (vinyl).
| Device ID | K891717 |
| 510k Number | K891717 |
| Device Name: | PATIENT EXAMINATION GLOVES (VINYL) |
| Classification | Vinyl Patient Examination Glove |
| Applicant | ULTI-MED INTL., INC. 1688 GLEN ELLYN RD. Glendale Heights, IL 60139 |
| Contact | Dominick Vecchione |
| Correspondent | Dominick Vecchione ULTI-MED INTL., INC. 1688 GLEN ELLYN RD. Glendale Heights, IL 60139 |
| Product Code | LYZ |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-03-21 |
| Decision Date | 1989-05-11 |