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 (sg).
| Device ID | K102074 |
| 510k Number | K102074 |
| Device Name: | POWDER FREE NITRILE EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGS, BLUE (SG) |
| Classification | Polymer Patient Examination Glove |
| Applicant | GX CORPORATION SDN BHD LOT 6487A, BATU 5 3/4, SEMENTA JALAN KAPAR Klang, Selangor Darul Ehsan, MY 42100 |
| Contact | Cho S Fong |
| Correspondent | Cho S Fong GX CORPORATION SDN BHD LOT 6487A, 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 | 2010-07-26 |
| Decision Date | 2010-11-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10304040040307 | K102074 | 000 |
| 10304040040291 | K102074 | 000 |
| 10304040040284 | K102074 | 000 |
| 10304040040277 | K102074 | 000 |
| 10304040040260 | K102074 | 000 |
| 09551005270000 | K102074 | 000 |