The following data is part of a premarket notification filed by Tg Medical Sdn. Bhd. with the FDA for Sterile Polyisoprene Surgical Powder Free Glove Tested For Use With Chemotherapy Drugs.
| Device ID | K171276 |
| 510k Number | K171276 |
| Device Name: | Sterile Polyisoprene Surgical Powder Free Glove Tested For Use With Chemotherapy Drugs |
| Classification | Surgeon's Gloves |
| Applicant | TG Medical SDN. BHD. Lot 5091, Jalan Teratai Batu 5, Off Jalan Meru Klang, MY 41050 |
| Contact | Fatima Wati Bt Mohamad |
| Correspondent | Fatima Wati Bt Mohamad TG Medical SDN. BHD. Lot 5091, Jalan Teratai Batu 5, Off Jalan Meru Klang, 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 | 2017-05-01 |
| Decision Date | 2017-08-21 |