The following data is part of a premarket notification filed by Quest Intl., Inc. with the FDA for Latex Examination Gloves Non-sterile.
| Device ID | K890356 |
| 510k Number | K890356 |
| Device Name: | LATEX EXAMINATION GLOVES NON-STERILE |
| Classification | Latex Patient Examination Glove |
| Applicant | QUEST INTL., INC. SUITE G, EXECUTIVE PARK CENTRE 6901 SOUTH DALLAS Fort Smith, AR 72903 |
| Contact | Joseph F Kearney |
| Correspondent | Joseph F Kearney QUEST INTL., INC. SUITE G, EXECUTIVE PARK CENTRE 6901 SOUTH DALLAS Fort Smith, AR 72903 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-01-24 |
| Decision Date | 1989-04-06 |