The following data is part of a premarket notification filed by Quality Gallant Sdn. Bhd. with the FDA for Powder Free Nitrile (blue And White) Examination Gloves.
| Device ID | K081592 |
| 510k Number | K081592 |
| Device Name: | POWDER FREE NITRILE (BLUE AND WHITE) EXAMINATION GLOVES |
| Classification | Polymer Patient Examination Glove |
| Applicant | QUALITY GALLANT SDN. BHD. LOT 1874, JALAN KAMPUNG DEW SIMPANG HALT Taiping, Perak, MY 34700 |
| Contact | Seah Bee Hoon |
| Correspondent | Seah Bee Hoon QUALITY GALLANT SDN. BHD. LOT 1874, JALAN KAMPUNG DEW SIMPANG HALT Taiping, Perak, MY 34700 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-06-06 |
| Decision Date | 2008-12-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10699320402051 | K081592 | 000 |
| 10075289130349 | K081592 | 000 |
| 10075289130332 | K081592 | 000 |
| 10075289130325 | K081592 | 000 |
| 10075289130318 | K081592 | 000 |
| 10075289130301 | K081592 | 000 |
| D79010240053 | K081592 | 000 |
| D79010240043 | K081592 | 000 |
| D79010240033 | K081592 | 000 |
| D79010240023 | K081592 | 000 |
| 10075289145114 | K081592 | 000 |
| 10075289145121 | K081592 | 000 |
| 10075289145138 | K081592 | 000 |
| 10699320402044 | K081592 | 000 |
| 10699320402037 | K081592 | 000 |
| 10699320402020 | K081592 | 000 |
| 10699320402013 | K081592 | 000 |
| 10699320492250 | K081592 | 000 |
| 10699320492243 | K081592 | 000 |
| 10699320492236 | K081592 | 000 |
| 10699320492229 | K081592 | 000 |
| 10075289145145 | K081592 | 000 |
| D79010240013 | K081592 | 000 |