Data / Medical devices / Malaysia / Matang MFG. Sdn. Bhd.
Matang MFG. Sdn. Bhd.: FDA-registered device maker in MERLIMAU Melaka, Malaysia, 6 510(k) clearances
Matang MFG. Sdn. Bhd. is registered with the FDA (registration 8041120) in MERLIMAU Melaka, Malaysia. It lists 3 device types. The FDA files 6 510(k) clearances under its listings, the newest dated October 17, 2012. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 8041120
- FEI number
- 3003602484
- Address
- Lot 10, Kawasan Perindustrian Serkam, Mukim Serkam, MERLIMAU Melaka, Malaysia, 77300
- Owner or operator
- MATANG MFG. SDN. BHD. (8041120)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- December 8, 2007
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| 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 |
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 17, 2012 | K122131 | POWDER FREE NITRILE EXAMINATION GLOVE-BLUE (CHEMOTHERAPY) | LZA | Substantially Equivalent | Matang Mfg. Sdn. Bhd. | accessdata.fda.gov |
| August 10, 2012 | K121368 | NITRILE EXAMINATION GLOVE, POWDER FREE (BLUE, BLACK OR WHITE) | LZA | Substantially Equivalent | Matang Mfg. Sdn. Bhd. | accessdata.fda.gov |
| April 15, 2008 | K072614 | MATANG BLACK, POWDER FREE AND POLYMER COATED LATEX EXAMINATION GLOVE | LYY | Substantially Equivalent | Matang Mfg. Sdn. Bhd. | accessdata.fda.gov |
| September 8, 2003 | K032549 | MATANG POWDER-FREE POLYCHLOROPRENE PATIENT EXAMINATION GLOVES | LZA | Substantially Equivalent | Matang Mfg. Sdn. Bhd. | accessdata.fda.gov |
| September 17, 2001 | K012558 | POWDER FREE LATEX PATIENT EXAMINATION GLOVES WITH ALOE VERA AND PROTEIN CONTENT LABELING CLAIM OF 50 MICROGRAMS OR LESS | LYY | Substantially Equivalent | Matang Mfg. Sdn. Bhd. | accessdata.fda.gov |
| November 30, 1998 | K982877 | MATANG POWDER-FREE LOW PROTEIN LATEX PATIENT EXAMINATION GLOVE | LYY | Substantially Equivalent | Matang Mfg. Sdn. Bhd. | accessdata.fda.gov |
Compare with other makers
- All makers of Medical Glove, Specialty
- All makers of Polymer Patient Examination Glove
- All makers of Latex Patient Examination Glove
Updated October 17, 2012. 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.