The following data is part of a premarket notification filed by Gx Corporation Sdn Bhd with the FDA for Powder Free White Sterilized Polyisoprene Surgical Gloves-tested For Use With The Chemotherapy Drugs.
| Device ID | K200915 |
| 510k Number | K200915 |
| Device Name: | Powder Free White Sterilized Polyisoprene Surgical Gloves-Tested For Use With The Chemotherapy Drugs |
| Classification | Surgeon's Gloves |
| Applicant | GX Corporation Sdn Bhd Lot 6491 Batu 5 3/4, Sementa Jalan Kapar Klang, MY 42100 |
| Contact | Khon Pu Foo |
| Correspondent | Khon Pu Foo GX Corporation Sdn Bhd Lot 6491 Batu 5 3/4, Sementa Jalan Kapar Klang, MY 42100 |
| Product Code | KGO |
| CFR Regulation Number | 878.4460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-04-06 |
| Decision Date | 2021-07-09 |