The following data is part of a premarket notification filed by Tg Medical Sdn Bhd with the FDA for Powder Free Black Nitrile Examination Gloves.
| Device ID | K113393 |
| 510k Number | K113393 |
| Device Name: | POWDER FREE BLACK NITRILE EXAMINATION GLOVES |
| Classification | Polymer Patient Examination Glove |
| Applicant | TG MEDICAL SDN BHD LOT 5091, JALAN TERATAI, BT 5, OFF JALAN MERU Klang, Selangor, MY 41050 |
| Contact | Noor A Saidin |
| Correspondent | Noor A Saidin TG MEDICAL SDN BHD LOT 5091, JALAN TERATAI, BT 5, OFF JALAN MERU Klang, Selangor, MY 41050 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-11-17 |
| Decision Date | 2012-09-11 |