Data / Medical devices / Malaysia / Tekmedic (M) Sdn Bhd
Tekmedic (M) Sdn Bhd: FDA-registered device maker in Melaka, Malaysia, 9 510(k) clearances
Tekmedic (M) Sdn Bhd is registered with the FDA (registration 9681163) in Melaka, Malaysia. It lists 3 device types. The FDA files 9 510(k) clearances under its listings, the newest dated January 18, 2013. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 9681163
- FEI number
- 3005680067
- Address
- Lot 4, Kaw.perindustrian Tanjung Kling Tanjung Bruas Jetty, Melaka, Malaysia, 76400
- Owner or operator
- TEKMEDIC (M) SDN BHD (9010436)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- November 20, 2007
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Latex Patient Examination Glove | LYY | 1 | 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 |
|---|---|---|---|---|---|---|
| January 18, 2013 | K121592 | POWDER FREE BLUE NITRILE EXAMINATION GLOVE TESTED WITH CHEMOTHERAPY DRUGS | LZA | Substantially Equivalent | Tekmedic (M) Sdn Bhd | accessdata.fda.gov |
| October 25, 2012 | K121594 | COLORED POWDER FREE LATEX EXAMINATION GLOVE (WHITE AND BLUE) | LYY | Substantially Equivalent | Tekmedic (M) Sdn Bhd | accessdata.fda.gov |
| October 11, 2012 | K121591 | FLAVORED POWDER FREE AND POLYMER COATED EXAMINATION GLOVE (VANLLA, GRAPE AND STRAWBERRY) | LYY | Substantially Equivalent | Tekmedic (M) Sdn Bhd | accessdata.fda.gov |
| August 3, 2012 | K121192 | NITRILE EXAMINATION GLOVES (WHITE, BLUE AND BLACK) | LZA | Substantially Equivalent | Tekmedic (M) Sdn Bhd | accessdata.fda.gov |
| June 25, 2010 | K100694 | COLORED POWDER FREE AND POLYMER COATED EXAMINATION GLOVE (BLUE, BLACK AND PINK) WITH A PROTEIN CLAIM OF LESS THAN | LYY | Substantially Equivalent | Tekmedic (M) Sdn Bhd | accessdata.fda.gov |
| December 17, 2001 | K013317 | TEKMEDIC POWDER-FREE WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS) | LYY | Substantially Equivalent | Tekmedic (M) Sdn Bhd | accessdata.fda.gov |
| February 7, 2000 | K994250 | TEKMEDIC POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) | LYY | Substantially Equivalent | Tekmedic (M) Sdn Bhd | accessdata.fda.gov |
| July 28, 1997 | K971949 | POWDER-FREE PATIENT EXAMINATION GLOVES | LYY | Substantially Equivalent | Tekmedic (M) Sdn Bhd | accessdata.fda.gov |
| September 29, 1993 | K930602 | LATEX EXAMINATION GLOVES, POWDER FREE | LYY | Substantially Equivalent | Tekmedic (M) Sdn Bhd | accessdata.fda.gov |
Compare with other makers
- All makers of Latex Patient Examination Glove
- All makers of Polymer Patient Examination Glove
- All makers of Medical Glove, Specialty
Updated January 18, 2013. 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.