Tekmedic (M) Sdn Bhd
Melaka, MY
TEKMEDIC (M) SDN BHD appears in FDA device records in Melaka, MY. FDA records list 11 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 11 510(k) clearances for Tekmedic (M) Sdn Bhd between 1989 and 2013. The busiest year on record is 2012, with 3. The most recent is 2013, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1989 | 1 |
| 1993 | 1 |
| 1997 | 1 |
| 2000 | 2 |
| 2001 | 1 |
| 2010 | 1 |
| 2012 | 3 |
| 2013 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K121592 | POWDER FREE BLUE NITRILE EXAMINATION GLOVE TESTED WITH CHEMOTHERAPY DRUGS | LZA | Substantially Equivalent | |
| K121594 | COLORED POWDER FREE LATEX EXAMINATION GLOVE (WHITE AND BLUE) | LYY | Substantially Equivalent | |
| K121591 | FLAVORED POWDER FREE AND POLYMER COATED EXAMINATION GLOVE (VANLLA, GRAPE AND STRAWBERRY) | LYY | Substantially Equivalent | |
| K121192 | NITRILE EXAMINATION GLOVES (WHITE, BLUE AND BLACK) | LZA | Substantially Equivalent | |
| K100694 | COLORED POWDER FREE AND POLYMER COATED EXAMINATION GLOVE (BLUE, BLACK AND PINK) WITH A PROTEIN CLAIM OF LESS THAN | LYY | Substantially Equivalent | |
| K013317 | TEKMEDIC POWDER-FREE WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS) | LYY | Substantially Equivalent | |
| K000555 | TEKMEDIC POWDERED SINGLE-USE LATEX PATIENT EXAMINATION GLOVES WITH PROTEIN & POWDER LABEL CLAIM CONTAINS 70MGM OR LESS O | LYY | Substantially Equivalent | |
| K994250 | TEKMEDIC POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) | LYY | Substantially Equivalent | |
| K971949 | POWDER-FREE PATIENT EXAMINATION GLOVES | LYY | Substantially Equivalent | |
| K930602 | LATEX EXAMINATION GLOVES, POWDER FREE | LYY | Substantially Equivalent | |
| K892094 | PATIENT EXAMINATION GLOVES (LATEX) | LYY | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 9681163 | 3005680067 | TEKMEDIC (M) SDN BHD | LOT 4, KAW.PERINDUSTRIAN TANJUNG KLING, MELAKA 76400 MY | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
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