The following data is part of a premarket notification filed by Matang Mfg. Sdn. Bhd. with the FDA for Matang Black, Powder Free And Polymer Coated Latex Examination Glove.
| Device ID | K072614 |
| 510k Number | K072614 |
| Device Name: | MATANG BLACK, POWDER FREE AND POLYMER COATED LATEX EXAMINATION GLOVE |
| Classification | Latex 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 | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-09-17 |
| Decision Date | 2008-04-15 |