Data / Medical devices / Malaysia / Gallant Quality Sdn. Bhd.
Gallant Quality Sdn. Bhd.: FDA-registered device maker in Taiping, Perak, Malaysia, 4 510(k) clearances
Gallant Quality Sdn. Bhd. is registered with the FDA (registration 9613998) in Taiping, Perak, Malaysia. It lists 4 device types. The FDA files 4 510(k) clearances under its listings, the newest dated October 9, 2015. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 9613998
- FEI number
- 3006581410
- Address
- Lot 1874, Jalan Kampung Dew, Taiping, Perak, Malaysia, 34700
- Owner or operator
- GALLANT QUALITY SDN BHD (9103901)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- March 19, 1998
- Registered through
- 2026
- Brand names listed
- Black Colored, Powder Free Nitrile Examination Gloves, Non-sterile, Tested for Use with Chemotherapy Drugs and Fentanyl, Blue Colored, Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate, NITRILE EXAMINATION GLOVES, Nitrile Examination Gloves, Olivia Claire Health, PATIENT PF LATEX EXAMINATION GLOVES, Powder Free Nitrile (Black) Examination Gloves, Powder Free Nitrile (Orange) Examination Gloves and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Fentanyl And Other Opioid Protection Glove | QDO | 1 | Contract manufacturer | accessdata.fda.gov |
| Latex Patient Examination Glove | LYY | 1 | Manufacturer | accessdata.fda.gov |
| Medical Glove, Specialty | LZC | 1 | Contract manufacturer | accessdata.fda.gov |
| Polymer Patient Examination Glove | LZA | 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 |
|---|---|---|---|---|---|---|
| October 9, 2015 | K151528 | Powder Free Nitrile (Black) Examination Gloves | LZA | Substantially Equivalent | Gallant Quality Sdn. Bhd. | accessdata.fda.gov |
| June 22, 2010 | K092874 | POWDER FREE NITRILE (DARK BLUE) EXAMINATION GLOVES | LZA | Substantially Equivalent | Quality Gallant Sdn. Bhd. | accessdata.fda.gov |
| December 3, 2008 | K081592 | POWDER FREE NITRILE (BLUE AND WHITE) EXAMINATION GLOVES | LZA | Substantially Equivalent | Quality Gallant Sdn. Bhd. | accessdata.fda.gov |
| July 13, 2007 | K071322 | POWDER FREE LATEX EXAMINATION GLOVES | LYY | Substantially Equivalent | Quality Gallant 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
Updated October 9, 2015. 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.