The following data is part of a premarket notification filed by Gx Corporation Sdn Bhd with the FDA for Powder Free Blue Nitrile Examination Gloves Tested For Use With 32 Chemotherapy Drugs And Fentanyl Citrate.
| Device ID | K183354 |
| 510k Number | K183354 |
| Device Name: | Powder Free Blue Nitrile Examination Gloves Tested For Use With 32 Chemotherapy Drugs And Fentanyl Citrate |
| Classification | Polymer Patient Examination Glove |
| Applicant | GX Corporation SDN BHD LOT 6491, Batu 5 3/4, Sementa, Jalan Kapar Klang, MY 42100 |
| Contact | Khon Pu Foo |
| Correspondent | Foo Khon Pu GX Corporation SDN BHD LOT 6491, Batu 5 3/4, Sementa, Jalan Kapar Klang, MY 42100 |
| Product Code | LZA |
| Subsequent Product Code | LZC |
| Subsequent Product Code | QDO |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-12-03 |
| Decision Date | 2019-06-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30851253007732 | K183354 | 000 |
| 30851253007725 | K183354 | 000 |
| 30851253007718 | K183354 | 000 |
| 30851253007701 | K183354 | 000 |
| 50885380174306 | K183354 | 000 |
| 50885380174290 | K183354 | 000 |
| 50885380174283 | K183354 | 000 |
| 50885380174276 | K183354 | 000 |