510(k) Report

FDA applicant

Tekmedic (M) Sdn Bhd

Jetty, Tanjung Kling, Malacca, MY11 decisions1989–20131 recall

FDA records 11 decisions for Tekmedic (M) Sdn Bhd (Jetty, Tanjung Kling, Malacca, MY) from 1989 to 2013: 11 510(k) clearances. Most are in product codes LYY (Latex Patient Examination Glove) and LZA (Polymer Patient Examination Glove). 1 recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general hospital panel, where it files most

How often FDA has decided Tekmedic (M) Sdn Bhd’s devices, and how often a recall has named them.

FDA decisions per year

1in 2013

2010: 12012: 32013: 1
2007high 3 (2012) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2011

2011: 1
2007high 1 (2011) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Tekmedic (M) Sdn Bhd by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Tekmedic (M) Sdn Bhd’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • LYYLatex Patient Examination Glove9decisions
  • LZAPolymer Patient Examination Glove2decisions

What has FDA decided for it lately?

  • K121592Powder Free Blue Nitrile Examination Glove Tested with Chemotherapy DrugsTekmedic (M) Sdn Bhd · 2013
  • K121594Colored Powder Free Latex Examination Glove (White and Blue)Tekmedic (M) Sdn Bhd · 2012
  • K121591Flavored Powder Free and Polymer Coated Examination Glove (Vanlla, Grape and Strawberry)Tekmedic (M) Sdn Bhd · 2012
  • K121192Nitrile Examination Gloves (White, Blue and Black)Tekmedic (M) Sdn Bhd · 2012
  • K100694Colored Powder Free and Polymer Coated Examination Glove (Blue, Black and Pink) with a Protein Claim of Less…Tekmedic (M) Sdn Bhd · 20101 recall
  • K013317Tekmedic Powder-Free with Protein Labeling Claim (50 Micrograms or Less)Tekmedic (M) Sdn Bhd · 2001
  • K000555Tekmedic Powdered Single-Use Latex Patient Examination Gloves with Protein & Powder Label Claim Contains…Tekmedic (M) Sdn Bhd · 2000
  • K994250Tekmedic Powder-Free Latex Examination Gloves with Protein Content Labeling Claim (50 Micrograms or Less)Tekmedic (M) Sdn Bhd · 2000

All 11 as Tekmedic (M) Sdn Bhd →

What has been recalled?

1 recall linked to its devices; the latest:

  • K100694Phantom-brand Black Latex Powder Free Examination Gloves, 100 gloves by weight, size…Dec 22, 2011