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 (blue, White).
| Device ID | K071119 |
| 510k Number | K071119 |
| Device Name: | POWDER FREE NITRILE EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGS (BLUE, WHITE) |
| Classification | Polymer Patient Examination Glove |
| Applicant | GX CORPORATION SDN BHD LOT 6487, BATU 5 3/4, SEMENTA JALAN KAPAR Klang, Selangor Darul Ehsan, 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 Darul Ehsan, 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 | 2007-04-20 |
| Decision Date | 2007-07-24 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00612479241282 | K071119 | 000 |
| 00612479241251 | K071119 | 000 |
| 00612479241220 | K071119 | 000 |
| 00612479241183 | K071119 | 000 |
| 30744514101594 | K071119 | 000 |
| 30744514101587 | K071119 | 000 |
| 30744514101570 | K071119 | 000 |
| 30744514101563 | K071119 | 000 |
| 30744514101501 | K071119 | 000 |