The following data is part of a premarket notification filed by American Healthcare Products (m) Sdn Bhd with the FDA for Uniseal Powder-free Latex Examination Gloves (blue & Green Colored).
| Device ID | K983614 |
| 510k Number | K983614 |
| Device Name: | UNISEAL POWDER-FREE LATEX EXAMINATION GLOVES (BLUE & GREEN COLORED) |
| Classification | Latex Patient Examination Glove |
| Applicant | AMERICAN HEALTHCARE PRODUCTS (M) SDN BHD SERULING 59, TAMAN KLANG JAYA Klang, MY |
| Contact | Tarani Devi |
| Correspondent | Tarani Devi AMERICAN HEALTHCARE PRODUCTS (M) SDN BHD SERULING 59, TAMAN KLANG JAYA Klang, MY |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-10-14 |
| Decision Date | 1999-02-04 |