510(k) Report

FDA applicant

Ksg Medicare Sdn. Bhd.

Tangkak, MY3 decisions2022–20240 recalls

FDA records 3 decisions for Ksg Medicare Sdn. Bhd. (Tangkak, MY) from 2022 to 2024: 3 510(k) clearances. All are in product code LZA (Polymer Patient Examination Glove). Since 2016 its 510(k)s took a median of 75 days from receipt to decision, against 111 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 Ksg Medicare Sdn. Bhd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2022: 22024: 1
2022high 2 (2022) · low 0 (2023)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2022.

FIG. 1 — Ksg Medicare Sdn. Bhd. by year, 2022–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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

See the 510(k) Report

Which product codes does it file in?

  • LZAPolymer Patient Examination Glove3decisions

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 75 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 111 days; 3 of its 3 were faster than that.

What has FDA decided for it lately?

  • K241745Powder Free Nitrile Examination Glove, Non-sterile, Tested for Use with 46 Chemotherapy Drugs, the Opioid…Ksg Medicare Sdn. Bhd. · 2024
  • K220209Powder Free Nitrile Examination Glove, Non-sterile (Blue)Ksg Medicare Sdn. Bhd. · 2022
  • K220215Powder Free Nitrile Examination Glove, Non-sterile, Tested for Use with Chemotherapy Drugs, and the Opioid…Ksg Medicare Sdn. Bhd. · 2022

All 3 as Ksg Medicare Sdn. Bhd. →