The following data is part of a premarket notification filed by Tg Medical Sdn Bhd with the FDA for Powder Free Latex Sterile Surgical Gloves.
| Device ID | K993562 |
| 510k Number | K993562 |
| Device Name: | POWDER FREE LATEX STERILE SURGICAL GLOVES |
| Classification | Surgeon's Gloves |
| Applicant | TG MEDICAL SDN BHD LOT 5091, JALAN TERATAI, BT 5, OFF JLN MERU Klang, Selangor D.e., MY 41050 |
| Contact | T.s. Puon |
| Correspondent | T.s. Puon TG MEDICAL SDN BHD LOT 5091, JALAN TERATAI, BT 5, OFF JLN MERU Klang, Selangor D.e., MY 41050 |
| Product Code | KGO |
| CFR Regulation Number | 878.4460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-10-21 |
| Decision Date | 1999-12-29 |