The following data is part of a premarket notification filed by Smart Glove Corporation Sdn. Bhd. with the FDA for Powderfree White Blue Sterilized Nitrile Copolymer Examination Gloves Tested For Use With Chemotherapy Drugs.
| Device ID | K183280 |
| 510k Number | K183280 |
| Device Name: | PowderFree White Blue Sterilized Nitrile Copolymer Examination Gloves Tested For Use With Chemotherapy Drugs |
| Classification | Polymer Patient Examination Glove |
| 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 | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-11-23 |
| Decision Date | 2019-07-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10075289715379 | K183280 | 000 |
| 10075289715362 | K183280 | 000 |
| 10075289715355 | K183280 | 000 |
| 10075289715348 | K183280 | 000 |
| 10075289715331 | K183280 | 000 |
| 10075289715324 | K183280 | 000 |
| 10075289715317 | K183280 | 000 |