The following data is part of a premarket notification filed by Gx Corporation Sdn Bhd with the FDA for Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs (pink, Black, Grey, And Blue Pepperment).
| Device ID | K081315 |
| 510k Number | K081315 |
| Device Name: | POWDER FREE NITRILE EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGS (PINK, BLACK, GREY, AND BLUE PEPPERMENT) |
| 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 | 2008-05-09 |
| Decision Date | 2008-08-11 |