The following data is part of a premarket notification filed by Smart Glove Corporation Sdn.bhd. with the FDA for Powder Free White, Blue Sterilized Nitrile Copolymer Surgical Gloves Tested For Use With Chemotherapy Drugs.
| Device ID | K181047 |
| 510k Number | K181047 |
| Device Name: | Powder Free White, Blue Sterilized Nitrile 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 | Khon Pu Foo |
| Correspondent | Khon Pu Foo 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 | 2018-04-19 |
| Decision Date | 2019-01-09 |