510(k) Report

FDA applicant

Gmp Medicare Sdn Bhd (F25)

Klang, MY3 decisions2016–20190 recalls

FDA records 3 decisions for Gmp Medicare Sdn Bhd (F25) (Klang, MY) from 2016 to 2019: 3 510(k) clearances. Most are in product codes LZC (Medical Glove, Specialty) and LZA (Polymer Patient Examination Glove). Since 2016 its 510(k)s took a median of 258 days from receipt to decision, against 200 for FDA’s reviews in the same codes and years. No 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 Gmp Medicare Sdn Bhd (F25)’s devices, and how often a recall has named them.

FDA decisions per year

1in 2019

2016: 12018: 12019: 1
2016high 1 (2016) · low 0 (2017)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2016.

FIG. 1 — Gmp Medicare Sdn Bhd (F25) by year, 2016–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Gmp Medicare Sdn Bhd (F25)’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?

  • LZCMedical Glove, Specialty2decisions
  • LZAPolymer Patient Examination Glove1decision

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 258 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 200 days; 0 of its 3 were faster than that.

Who builds on its devices?

Later devices cite its devices 1 time; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K172867Nitrile Examination Powder Free Glove, Black, Nitrile Examination Powder Free Glove, OrangeGmp Medicare Sdn Bhd (F25) · 20181cites it

What has FDA decided for it lately?

  • K182382Nitrile Examination Powder Free Glove, Aloe Vera, Blue, Nitrile Examination Powder Free Glove, Aloe Vera, PinkGmp Medicare Sdn Bhd (F25) · 2019
  • K172867Nitrile Examination Powder Free Glove, Black, Nitrile Examination Powder Free Glove, OrangeGmp Medicare Sdn Bhd (F25) · 2018
  • K152222NITRILE BLUE POWDER FREE EXAMINATION GLOVES tested for use with Chemotheraphy DrugsGmp Medicare Sdn Bhd (F25) · 2016

All 3 as Gmp Medicare Sdn Bhd (F25) →