The following data is part of a premarket notification filed by Gx Corporation Sdn Bhd with the FDA for Powder Free Latex Examination Gloves (18 Ml), Blue Tested For Use With Chemotherapy Drugs.
| Device ID | K101828 |
| 510k Number | K101828 |
| Device Name: | POWDER FREE LATEX EXAMINATION GLOVES (18 ML), BLUE TESTED FOR USE WITH CHEMOTHERAPY DRUGS |
| Classification | Latex Patient Examination Glove |
| Applicant | GX CORPORATION SDN BHD LOT 6487, BATU 5 3/4, SEMENTA JALAN KAPAR Klang, MY 42100 |
| Contact | Cho Sow Fong |
| Correspondent | Cho Sow Fong GX CORPORATION SDN BHD LOT 6487, BATU 5 3/4, SEMENTA JALAN KAPAR Klang, MY 42100 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-07-01 |
| Decision Date | 2010-10-04 |