The following data is part of a premarket notification filed by Supermax Glove Manufacturing Sdn Bhd with the FDA for Chlorinated Powder Free Latex Medical Examination Gloves With Aloe Vera.
| Device ID | K013589 |
| 510k Number | K013589 |
| Device Name: | CHLORINATED POWDER FREE LATEX MEDICAL EXAMINATION GLOVES WITH ALOE VERA |
| Classification | Latex 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 | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-10-30 |
| Decision Date | 2002-01-08 |