510(k) Report

FDA applicant

New Era Medicare Sdn. Bhd.

Teluk Intan, MY3 decisions2022–20230 recalls

FDA records 3 decisions for New Era Medicare Sdn. Bhd. (Teluk Intan, MY) from 2022 to 2023: 3 510(k) clearances. Most are in product codes LZA (Polymer Patient Examination Glove) and KGO (Surgeon'S Gloves). Since 2016 its 510(k)s took a median of 191 days from receipt to decision, against 150 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 New Era Medicare Sdn. Bhd.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2023

2022: 12023: 2
2022high 2 (2023) · low 0 (2024)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2022.

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

Planning a device like New Era 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 Glove1decision
  • KGOSurgeon'S Gloves1decision
  • LYYLatex Patient Examination Glove1decision

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 191 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 150 days; 1 of its 3 were faster than that.

What has FDA decided for it lately?

  • K230314Sterile Powder Free Nitrile Examination Gloves (Blue, Black &White Colors)New Era Medicare Sdn. Bhd. · 2023
  • K221424Sterile Surgical Powder Free Latex GloveNew Era Medicare Sdn. Bhd. · 2023
  • K221667Non Sterile Powder Free Latex Examination GloveNew Era Medicare Sdn. Bhd. · 2022

All 3 as New Era Medicare Sdn. Bhd. →