The following data is part of a premarket notification filed by Tg Medical Sdn Bhd with the FDA for Tg Medical Powdered Nitrile Blue Examination Gloves.
| Device ID | K992841 |
| 510k Number | K992841 |
| Device Name: | TG MEDICAL POWDERED NITRILE BLUE EXAMINATION GLOVES |
| 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 | Wee-chai Lim |
| Correspondent | Wee-chai Lim 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 | 1999-08-24 |
| Decision Date | 1999-10-29 |