The following data is part of a premarket notification filed by Supermax Glove Manufacturing Sdn Bhd with the FDA for Green Powder Free Nitrile Medical Examination Gloves With Peppermint Flavor.
| Device ID | K024083 |
| 510k Number | K024083 |
| Device Name: | GREEN POWDER FREE NITRILE MEDICAL EXAMINATION GLOVES WITH PEPPERMINT FLAVOR |
| Classification | Polymer Patient Examination Glove |
| Applicant | SUPERMAX GLOVE MANUFACTURING SDN BHD LOT 42, PUTRA INDUSTRIAL PARK BUKIT RAHMAN PUTRA Sungai Buloh, Selangor, MY 47000 |
| Contact | Stanley Thai |
| Correspondent | Stanley Thai SUPERMAX GLOVE MANUFACTURING SDN BHD LOT 42, PUTRA INDUSTRIAL PARK BUKIT RAHMAN PUTRA Sungai Buloh, Selangor, MY 47000 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-12-11 |
| Decision Date | 2003-01-10 |