Gx Corporation Sdn Bhd
Klang, Selangor, MY
Gx Corporation Sdn Bhd appears in FDA device records in Klang, Selangor, MY. FDA records list 18 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 18
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 18 510(k) clearances for Gx Corporation Sdn Bhd between 2007 and 2021. The busiest year on record is 2009, with 7. The most recent is 2021, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2007 | 3 |
| 2008 | 3 |
| 2009 | 7 |
| 2010 | 2 |
| 2011 | 1 |
| 2019 | 1 |
| 2021 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K200915 | Powder Free White Sterilized Polyisoprene Surgical Gloves-Tested for Use with The Chemotherapy Drugs | KGO | Substantially Equivalent | |
| K183354 | Powder Free Blue Nitrile Examination Gloves Tested for use with 32 Chemotherapy Drugs and Fentanyl Citrate | LZA | Substantially Equivalent | |
| K111328 | POWDER FREE NITRILE EXAMINATION GLOVES | LZA | Substantially Equivalent | |
| K102074 | POWDER FREE NITRILE EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGS, BLUE (SG) | LZA | Substantially Equivalent | |
| K101828 | POWDER FREE LATEX EXAMINATION GLOVES (18 ML), BLUE TESTED FOR USE WITH CHEMOTHERAPY DRUGS | LYY | Substantially Equivalent | |
| K091851 | STERILE, POWDER FREE NITRILE EXAMINATION GLOVE, BLUE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS | LZA | Substantially Equivalent | |
| K092072 | POWDER FREE NITRILE EXAMINATION GLOVE, GRAPE SCENTED, BLUE | LZA | Substantially Equivalent | |
| K091643 | POWDER FREE LATEX EXAMINATION GLOVES, BLUE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS | LZC | Substantially Equivalent | |
| K092200 | POWDER FREE NITRILE EXAMINATION GLOVES, ORANGE (ORANGE SCENTED), WHITE (VANILLA SCENTED) | LZA | Substantially Equivalent | |
| K091151 | POWDER FREE NITRILE EXAMINATION GLOVE, GREEN TEA SCENTED, GREEN | LZA | Substantially Equivalent | |
| K090412 | POWDER FREE NITRILE EXAMINATION GLOVES (PINK, GREEN, ORANGE,WHITE). | LZA | Substantially Equivalent | |
| K083717 | POWDER FREE NITRILE EXAMINATION GLOVES, BUBBLE GUM SCENTED, PINK | LZA | Substantially Equivalent | |
| K081315 | POWDER FREE NITRILE EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGS (PINK, BLACK, GREY, AND BLUE PEPPERMENT) | LZA | Substantially Equivalent | |
| K080937 | POWDER FREE NITRILE EXAMINATION GLOVE, ORANGE | LZA | Substantially Equivalent | |
| K080066 | VFLEX POWDER FREE NITRILE EXAMINATION GLOVE (BLUE, WHITE, PINK, AND GRAY COLOR) | LZA | Substantially Equivalent | |
| K071119 | POWDER FREE NITRILE EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGS (BLUE, WHITE) | LZA | Substantially Equivalent | |
| K070097 | POWDER FREE NITRILE EXAMINATION GLOVES, PEPPERMINT SCENTED, BLUE COLOR | LZA | Substantially Equivalent | |
| K070096 | POWDER FREE NITRILE EXAMINATION GLOVES, BLUE, WHITE, PINK, BLACK AND GRAY COLOR | LZA | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
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Data as of , FDA export datePage updated Source: openFDA, public domain