The following data is part of a premarket notification filed by Matang Mfg. Sdn. Bhd. with the FDA for Nitrile Examination Glove, Powder Free (blue, Black Or White).
| Device ID | K121368 |
| 510k Number | K121368 |
| Device Name: | NITRILE EXAMINATION GLOVE, POWDER FREE (BLUE, BLACK OR WHITE) |
| Classification | Polymer Patient Examination Glove |
| Applicant | MATANG MFG. SDN. BHD. LOT 10, KAWASAN PERINDUSTRIAN SERKAM, MUKIM SERKAM Merlimau, Melaka, MY 77300 |
| Contact | Leslie Leong |
| Correspondent | Leslie Leong MATANG MFG. SDN. BHD. LOT 10, KAWASAN PERINDUSTRIAN SERKAM, MUKIM SERKAM Merlimau, Melaka, MY 77300 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-05-07 |
| Decision Date | 2012-08-10 |