The following data is part of a premarket notification filed by Gallant Quality Sdn. Bhd. with the FDA for Powder Free Nitrile (black) Examination Gloves.
| Device ID | K151528 |
| 510k Number | K151528 |
| Device Name: | Powder Free Nitrile (Black) Examination Gloves |
| Classification | Polymer Patient Examination Glove |
| Applicant | GALLANT QUALITY SDN. BHD. LOT 1874, JALAN KAMPUNG DEW Taiping, MY 34700 |
| Contact | Sumathi Saravana Sami |
| Correspondent | Sumathi Saravana Sami GALLANT QUALITY SDN. BHD. LOT 1874, JALAN KAMPUNG DEW Taiping, 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 | 2015-06-08 |
| Decision Date | 2015-10-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10075289145107 | K151528 | 000 |
| 10787081126849 | K151528 | 000 |
| 10787081126832 | K151528 | 000 |
| 10787081126825 | K151528 | 000 |
| 06531950022834 | K151528 | 000 |
| 06531950022520 | K151528 | 000 |
| 06531950022216 | K151528 | 000 |
| 10075289222853 | K151528 | 000 |
| 10075289222846 | K151528 | 000 |
| 10075289222839 | K151528 | 000 |
| 10075289222822 | K151528 | 000 |
| 10787081126856 | K151528 | 000 |
| 10787081126863 | K151528 | 000 |
| 10075289145091 | K151528 | 000 |
| 10075289145084 | K151528 | 000 |
| 10075289145077 | K151528 | 000 |
| 10075289145060 | K151528 | 000 |
| 10075289145053 | K151528 | 000 |
| 10075289145046 | K151528 | 000 |
| 10075289145022 | K151528 | 000 |
| 10075289145015 | K151528 | 000 |
| 10075289145008 | K151528 | 000 |
| 06531950022698 | K151528 | 000 |
| 06531950022070 | K151528 | 000 |