The following data is part of a premarket notification filed by Tg Medical Sdn Bhd with the FDA for Tg Medical Powder-free Latex Examination Glove Protein Labeling Claim (50 Micrograms Or Less).
| Device ID | K982872 |
| 510k Number | K982872 |
| Device Name: | TG MEDICAL POWDER-FREE LATEX EXAMINATION GLOVE PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS) |
| Classification | Latex Patient Examination Glove |
| Applicant | TG MEDICAL SDN BHD LOT 5091, JALAN TERATAI, BT 5, OFF JLN MERU Klang, Selangor D.e., MY 41050 |
| Contact | W.c. Lim |
| Correspondent | W.c. Lim TG MEDICAL SDN BHD LOT 5091, JALAN TERATAI, BT 5, OFF JLN MERU Klang, Selangor D.e., MY 41050 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-08-14 |
| Decision Date | 1998-10-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B3408628L1 | K982872 | 000 |
| B3408622XL1 | K982872 | 000 |
| B3408622S1 | K982872 | 000 |
| B3408622M1 | K982872 | 000 |
| B3408622L1 | K982872 | 000 |
| B340791965XL1 | K982872 | 000 |
| B340791960L1 | K982872 | 000 |
| B340791955M1 | K982872 | 000 |
| B340791950S1 | K982872 | 000 |