The following data is part of a premarket notification filed by Supermax Sdn Bhd with the FDA for Supergloves, Powder Free Nitrile Examination Gloves.
| Device ID | K993258 |
| 510k Number | K993258 |
| Device Name: | SUPERGLOVES, POWDER FREE NITRILE EXAMINATION GLOVES |
| Classification | Polymer Patient Examination Glove |
| Applicant | SUPERMAX SDN BHD LOT 42, JALAN BRP 9/2, BUKIT RAHMAN PUTRA,PUTRA INDUSTRIAL 47000 Sungai Buloh-selangor, MY |
| Contact | Stanley Thai |
| Correspondent | Stanley Thai SUPERMAX SDN BHD LOT 42, JALAN BRP 9/2, BUKIT RAHMAN PUTRA,PUTRA INDUSTRIAL 47000 Sungai Buloh-selangor, MY |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-09-29 |
| Decision Date | 1999-10-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 19555002110236 | K993258 | 000 |
| 19555002102811 | K993258 | 000 |
| 19555002102804 | K993258 | 000 |
| 19555002102736 | K993258 | 000 |
| 19555002102729 | K993258 | 000 |
| 19555002102712 | K993258 | 000 |
| 19555002102705 | K993258 | 000 |
| 19555002102699 | K993258 | 000 |
| 19555002102347 | K993258 | 000 |
| 19555002102330 | K993258 | 000 |
| 19555002102323 | K993258 | 000 |
| 19555002102316 | K993258 | 000 |
| 19555002102309 | K993258 | 000 |
| 19555002102248 | K993258 | 000 |
| 19555002102231 | K993258 | 000 |
| 19555002102224 | K993258 | 000 |
| 19555002102217 | K993258 | 000 |
| 19555002102828 | K993258 | 000 |
| 19555002102835 | K993258 | 000 |
| 19555002110229 | K993258 | 000 |
| 19555002110212 | K993258 | 000 |
| 19555002110205 | K993258 | 000 |
| 19555002105607 | K993258 | 000 |
| 19555002105591 | K993258 | 000 |
| 19555002105584 | K993258 | 000 |
| 19555002105577 | K993258 | 000 |
| 19555002105560 | K993258 | 000 |
| 19555002105348 | K993258 | 000 |
| 19555002105232 | K993258 | 000 |
| 19555002105225 | K993258 | 000 |
| 19555002105218 | K993258 | 000 |
| 19555002105201 | K993258 | 000 |
| 19555002105195 | K993258 | 000 |
| 19555002102989 | K993258 | 000 |
| 19555002102842 | K993258 | 000 |
| 19555002102200 | K993258 | 000 |