Tekmedic (M) Sdn Bhd: FDA filings under this applicant name
FDA lists 11 510(k) clearances under the applicant name “Tekmedic (M) Sdn Bhd” (first 1989, latest 2013), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 106 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 3 | 133 |
| 2013 | 1 | 232 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LYY | Latex Patient Examination Glove | 9 | 9 |
| LZA | Polymer Patient Examination Glove | 2 | 2 |
Review panels
- General Hospital (11)
Most recent Tekmedic (M) Sdn Bhd 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K121592 | POWDER FREE BLUE NITRILE EXAMINATION GLOVE TESTED WITH CHEMOTHERAPY DRUGS | LZA | 2013-01-18 | 232 |
| K121594 | COLORED POWDER FREE LATEX EXAMINATION GLOVE (WHITE AND BLUE) | LYY | 2012-10-25 | 147 |
| K121591 | FLAVORED POWDER FREE AND POLYMER COATED EXAMINATION GLOVE (VANLLA, GRAPE AND STRAWBERRY) | LYY | 2012-10-11 | 133 |
| K121192 | NITRILE EXAMINATION GLOVES (WHITE, BLUE AND BLACK) | LZA | 2012-08-03 | 106 |
| K100694 | COLORED POWDER FREE AND POLYMER COATED EXAMINATION GLOVE (BLUE, BLACK AND PINK) WITH A PROTEIN CLAIM OF LESS THAN | LYY | 2010-06-25 | 106 |
| K013317 | TEKMEDIC POWDER-FREE WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS) | LYY | 2001-12-17 | 74 |
| K000555 | TEKMEDIC POWDERED SINGLE-USE LATEX PATIENT EXAMINATION GLOVES WITH PROTEIN & POWDER LABEL CLAIM CONTAINS 70MGM OR LESS O | LYY | 2000-04-12 | 54 |
| K994250 | TEKMEDIC POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) | LYY | 2000-02-07 | 53 |
| K971949 | POWDER-FREE PATIENT EXAMINATION GLOVES | LYY | 1997-07-28 | 61 |
| K930602 | LATEX EXAMINATION GLOVES, POWDER FREE | LYY | 1993-09-29 | 239 |
1 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Tekmedic (M) Sdn Bhd.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Tekmedic (M) Sdn Bhd?
FDA lists 11 510(k) clearances under the applicant name “Tekmedic (M) Sdn Bhd” (first 1989, latest 2013), across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Tekmedic (M) Sdn Bhd?
The median time from FDA receipt to decision across 510(k)s cleared under the name Tekmedic (M) Sdn Bhd is 106 days.
Which FDA product codes appear under Tekmedic (M) Sdn Bhd?
The most frequent FDA product codes under this applicant name are LYY (Latex Patient Examination Glove, 9); LZA (Polymer Patient Examination Glove, 2).
Next steps
- See all 11 Tekmedic (M) Sdn Bhd clearances with predicates and recalls
- Run predicate analysis for product code LYY, Tekmedic (M) Sdn Bhd's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.