Data / Medical devices / Malaysia / GX Corporation Sdn Bhd (Specialty Plant)
GX Corporation Sdn Bhd (Specialty Plant): FDA-registered device maker in Klang Selangor, Malaysia, 19 510(k) clearances
GX Corporation Sdn Bhd (Specialty Plant) is registered with the FDA (registration 3012441043) in Klang Selangor, Malaysia. It lists 5 device types. The FDA files 19 510(k) clearances under its listings, the newest dated July 9, 2021. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3012441043
- Address
- Plot 6497-A, Lorong Haji Abdul Manan 5 3/4 Milestone, Sementa. Jalan kapar, Klang Selangor, Malaysia, 42100
- Owner or operator
- GX CORPORATION SDN BHD (9095340)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- February 15, 2007
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Fentanyl And Other Opioid Protection Glove | QDO | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Latex Patient Examination Glove | LYY | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Medical Glove, Specialty | LZC | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Polymer Patient Examination Glove | LZA | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Surgeon'S Gloves | KGO | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 9, 2021 | K200915 | Powder Free White Sterilized Polyisoprene Surgical Gloves-Tested for Use with The Chemotherapy Drugs | KGO | Substantially Equivalent | Gx Corporation Sdn Bhd | accessdata.fda.gov |
| June 20, 2019 | K183354 | Powder Free Blue Nitrile Examination Gloves Tested for use with 32 Chemotherapy Drugs and Fentanyl Citrate | LZA | Substantially Equivalent | Gx Corporation Sdn Bhd | accessdata.fda.gov |
| July 15, 2011 | K111328 | POWDER FREE NITRILE EXAMINATION GLOVES | LZA | Substantially Equivalent | Gx Corporation Sdn Bhd | accessdata.fda.gov |
| November 2, 2010 | K102074 | POWDER FREE NITRILE EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGS, BLUE (SG) | LZA | Substantially Equivalent | Gx Corporation Sdn Bhd | accessdata.fda.gov |
| October 4, 2010 | K101828 | POWDER FREE LATEX EXAMINATION GLOVES (18 ML), BLUE TESTED FOR USE WITH CHEMOTHERAPY DRUGS | LYY | Substantially Equivalent | Gx Corporation Sdn Bhd | accessdata.fda.gov |
| February 19, 2010 | K093759 | MULTIPLE NAME MODEL MULTIPLE | LZA | Substantially Equivalent | Gx Corporation Sdn Bhd (Plant 1) | accessdata.fda.gov |
| December 28, 2009 | K091851 | STERILE, POWDER FREE NITRILE EXAMINATION GLOVE, BLUE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS | LZA | Substantially Equivalent | Gx Corporation Sdn Bhd | accessdata.fda.gov |
| November 4, 2009 | K092072 | POWDER FREE NITRILE EXAMINATION GLOVE, GRAPE SCENTED, BLUE | LZA | Substantially Equivalent | Gx Corporation Sdn Bhd | accessdata.fda.gov |
| November 2, 2009 | K091643 | POWDER FREE LATEX EXAMINATION GLOVES, BLUE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS | LZC | Substantially Equivalent | Gx Corporation Sdn Bhd | accessdata.fda.gov |
| September 16, 2009 | K092200 | POWDER FREE NITRILE EXAMINATION GLOVES, ORANGE (ORANGE SCENTED), WHITE (VANILLA SCENTED) | LZA | Substantially Equivalent | Gx Corporation Sdn Bhd | accessdata.fda.gov |
| June 1, 2009 | K091151 | POWDER FREE NITRILE EXAMINATION GLOVE, GREEN TEA SCENTED, GREEN | LZA | Substantially Equivalent | Gx Corporation Sdn Bhd | accessdata.fda.gov |
| June 1, 2009 | K090412 | POWDER FREE NITRILE EXAMINATION GLOVES (PINK, GREEN, ORANGE,WHITE). | LZA | Substantially Equivalent | Gx Corporation Sdn Bhd | accessdata.fda.gov |
| January 30, 2009 | K083717 | POWDER FREE NITRILE EXAMINATION GLOVES, BUBBLE GUM SCENTED, PINK | LZA | Substantially Equivalent | Gx Corporation Sdn Bhd | accessdata.fda.gov |
| August 11, 2008 | K081315 | POWDER FREE NITRILE EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGS (PINK, BLACK, GREY, AND BLUE PEPPERMENT) | LZA | Substantially Equivalent | Gx Corporation Sdn Bhd | accessdata.fda.gov |
| May 23, 2008 | K080937 | POWDER FREE NITRILE EXAMINATION GLOVE, ORANGE | LZA | Substantially Equivalent | Gx Corporation Sdn Bhd | accessdata.fda.gov |
| March 5, 2008 | K080066 | VFLEX POWDER FREE NITRILE EXAMINATION GLOVE (BLUE, WHITE, PINK, AND GRAY COLOR) | LZA | Substantially Equivalent | Gx Corporation Sdn Bhd | accessdata.fda.gov |
| July 24, 2007 | K071119 | POWDER FREE NITRILE EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGS (BLUE, WHITE) | LZA | Substantially Equivalent | Gx Corporation Sdn Bhd | accessdata.fda.gov |
| March 23, 2007 | K070097 | POWDER FREE NITRILE EXAMINATION GLOVES, PEPPERMINT SCENTED, BLUE COLOR | LZA | Substantially Equivalent | Gx Corporation Sdn Bhd | accessdata.fda.gov |
| March 14, 2007 | K070096 | POWDER FREE NITRILE EXAMINATION GLOVES, BLUE, WHITE, PINK, BLACK AND GRAY COLOR | LZA | Substantially Equivalent | Gx Corporation Sdn Bhd | accessdata.fda.gov |
Compare with other makers
- All makers of Polymer Patient Examination Glove
- All makers of Medical Glove, Specialty
- All makers of Fentanyl And Other Opioid Protection Glove
- All makers of Latex Patient Examination Glove
- All makers of Surgeon'S Gloves
Updated July 9, 2021. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.