The following data is part of a premarket notification filed by Tg Medical Sdn Bhd with the FDA for Powder Free Blue Nitrile Glove.
| Device ID | K990668 |
| 510k Number | K990668 |
| Device Name: | POWDER FREE BLUE NITRILE GLOVE |
| Classification | Polymer Patient Examination Glove |
| Applicant | TG MEDICAL SDN BHD LOT 5091, JALAN TERATAI, BT 5, OFF JLN MERU Klang, Selangor D.e., MY 41050 |
| Contact | Lim Wee Chai |
| Correspondent | Lim Wee Chai TG MEDICAL SDN BHD LOT 5091, JALAN TERATAI, BT 5, OFF JLN MERU Klang, Selangor D.e., 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 | 1999-03-02 |
| Decision Date | 1999-06-03 |