The following data is part of a premarket notification filed by Gx Corporation Sdn Bhd with the FDA for Powder Free Nitrile Examination Glove, Green Tea Scented, Green.
Device ID | K091151 |
510k Number | K091151 |
Device Name: | POWDER FREE NITRILE EXAMINATION GLOVE, GREEN TEA SCENTED, GREEN |
Classification | Polymer Patient Examination Glove |
Applicant | GX CORPORATION SDN BHD LOT 6487, BATU 5 3/4, SEMENTA JALAN KAPAR Klang, MY 42100 |
Contact | Foo K Pu |
Correspondent | Foo K Pu GX 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 | 2009-04-20 |
Decision Date | 2009-06-01 |