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 |