The following data is part of a premarket notification filed by Gx Corporation Sdn Bhd with the FDA for Vflex Powder Free Nitrile Examination Glove (blue, White, Pink, And Gray Color).
| Device ID | K080066 |
| 510k Number | K080066 |
| Device Name: | VFLEX POWDER FREE NITRILE EXAMINATION GLOVE (BLUE, WHITE, PINK, AND GRAY COLOR) |
| Classification | Polymer Patient Examination Glove |
| Applicant | GX CORPORATION SDN BHD LOT 6487, BATU 5 3/4, SEMENTA JALAN KAPAR Klang, Selangor, MY 42100 |
| Contact | Foo Khon Pu |
| Correspondent | Foo Khon Pu GX CORPORATION SDN BHD LOT 6487, BATU 5 3/4, SEMENTA JALAN KAPAR Klang, Selangor, 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 | 2008-01-10 |
| Decision Date | 2008-03-05 |