The following data is part of a premarket notification filed by Supermax Sdn Bhd with the FDA for Supergloves, Polymer Coated Powder Free Latex Examination Gloves.
| Device ID | K991415 |
| 510k Number | K991415 |
| Device Name: | SUPERGLOVES, POLYMER COATED POWDER FREE LATEX EXAMINATION GLOVES |
| Classification | Latex 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 | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-04-23 |
| Decision Date | 1999-05-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 19555002101593 | K991415 | 000 |
| 19555002101418 | K991415 | 000 |
| 19555002101425 | K991415 | 000 |
| 19555002101432 | K991415 | 000 |
| 19555002101449 | K991415 | 000 |
| 19555002101555 | K991415 | 000 |
| 19555002101562 | K991415 | 000 |
| 19555002101579 | K991415 | 000 |
| 19555002101586 | K991415 | 000 |
| 19555002101401 | K991415 | 000 |