The following data is part of a premarket notification filed by Supermax Sdn Bhd with the FDA for Supergloves Powdered Nitrile.
| Device ID | K980966 |
| 510k Number | K980966 |
| Device Name: | SUPERGLOVES POWDERED NITRILE |
| Classification | Polymer Patient Examination Glove |
| Applicant | SUPERMAX SDN BHD LOT 42, PUTRA INDUSTRIAL PARK BUKIT RAHMAN PUTRA Sungai Pelong, Selangor, MY 47500 |
| Contact | Stanley Thai |
| Correspondent | Stanley Thai SUPERMAX SDN BHD LOT 42, PUTRA INDUSTRIAL PARK BUKIT RAHMAN PUTRA Sungai Pelong, Selangor, MY 47500 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-03-16 |
| Decision Date | 1998-07-22 |