The following data is part of a premarket notification filed by American Healthcare Products, Inc. with the FDA for Uniseal Gloves (low Protein,powder Free).
| Device ID | K963211 |
| 510k Number | K963211 |
| Device Name: | UNISEAL GLOVES (LOW PROTEIN,POWDER FREE) |
| Classification | Latex Patient Examination Glove |
| Applicant | AMERICAN HEALTHCARE PRODUCTS, INC. 4923 HASKELL AVE. Encino, CA 91436 |
| Contact | Tony Djie |
| Correspondent | Tony Djie AMERICAN HEALTHCARE PRODUCTS, INC. 4923 HASKELL AVE. Encino, CA 91436 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-08-16 |
| Decision Date | 1996-11-22 |