The following data is part of a premarket notification filed by Supermax Sdn Bhd with the FDA for Chlorinated Powder Free Nitrile Medical Examination Gloves With Aloe Vera.
| Device ID | K013774 |
| 510k Number | K013774 |
| Device Name: | CHLORINATED POWDER FREE NITRILE MEDICAL EXAMINATION GLOVES WITH ALOE VERA |
| Classification | Polymer Patient Examination Glove |
| Applicant | SUPERMAX SDN BHD LOT 42, PUTRA INDUSTRIAL PARK BUKIT RAHMAN PUTRA Sungai Pelong, Selangor, MY 47500 |
| Contact | Priscilla Wee |
| Correspondent | Priscilla Wee 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 | 2001-11-13 |
| Decision Date | 2002-03-05 |