The following data is part of a premarket notification filed by American Healthcare Products (m) Sdn Bhd with the FDA for Nitrile Powder-free Uniseal Gloves.
| Device ID | K982218 |
| 510k Number | K982218 |
| Device Name: | NITRILE POWDER-FREE UNISEAL GLOVES |
| Classification | Polymer Patient Examination Glove |
| Applicant | AMERICAN HEALTHCARE PRODUCTS (M) SDN BHD PT 7521 TAMAN SEMARAK II LIGHT INDUSTRIAL PARK Nilai, Negeri Sembilan 71800, MY 71800 |
| Contact | Tarani Devi |
| Correspondent | Tarani Devi AMERICAN HEALTHCARE PRODUCTS (M) SDN BHD PT 7521 TAMAN SEMARAK II LIGHT INDUSTRIAL PARK Nilai, Negeri Sembilan 71800, MY 71800 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-06-24 |
| Decision Date | 1998-11-30 |