The following data is part of a premarket notification filed by American Intl. Health Industries P.r., Inc. with the FDA for Latex Dental & Examination Gloves.
| Device ID | K896881 |
| 510k Number | K896881 |
| Device Name: | LATEX DENTAL & EXAMINATION GLOVES |
| Classification | Latex Patient Examination Glove |
| Applicant | AMERICAN INTL. HEALTH INDUSTRIES P.R., INC. P.O. BOX 1680 Canovanas, PR 00629 |
| Contact | Mike Gomez |
| Correspondent | Mike Gomez AMERICAN INTL. HEALTH INDUSTRIES P.R., INC. P.O. BOX 1680 Canovanas, PR 00629 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-12-08 |
| Decision Date | 1990-04-25 |