The following data is part of a premarket notification filed by Smart Glove Corporation Sdn.bhd with the FDA for Powder Free White, Green Sterilized Polychloroprene Copolymer Surgical Gloves - Tested For Use With Chemotherapy Drugs.
| Device ID | K180221 |
| 510k Number | K180221 |
| Device Name: | Powder Free White, Green Sterilized Polychloroprene Copolymer Surgical Gloves - Tested For Use With Chemotherapy Drugs |
| Classification | Surgeon's Gloves |
| Applicant | Smart Glove Corporation Sdn.Bhd Lot 6487, Batu 5 3/4, Sementa, Jalan Kapar, Klang, MY 42100 |
| Contact | Foo Khon Pu |
| Correspondent | Foo Khon Pu Smart Glove Corporation Sdn.Bhd Lot 6487, 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 | 2018-01-25 |
| Decision Date | 2018-08-08 |