510(k) Report

FDA applicant

Iconic Medicare Sdn Bhd

Batu Kawan, MY3 decisions2021–20230 recalls

FDA records 3 decisions for Iconic Medicare Sdn Bhd (Batu Kawan, MY) from 2021 to 2023: 3 510(k) clearances. Most are in product codes LZA (Polymer Patient Examination Glove) and LYY (Latex Patient Examination Glove). Since 2016 its 510(k)s took a median of 151 days from receipt to decision, against 111 for FDA’s reviews in the same codes and years. Its devices cite 3 predicates, 0 of them its own earlier devices. 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 Iconic Medicare Sdn Bhd’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2021: 12022: 12023: 1
2021high 1 (2021) · low 0 (2024)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2021.

FIG. 1 — Iconic Medicare Sdn Bhd by year, 2021–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Iconic 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.

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Which product codes does it file in?

  • LZAPolymer Patient Examination Glove2decisions
  • LYYLatex Patient Examination Glove1decision

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 151 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; 1 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 3 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K222181Iconic Blue Nitrile Glove - Tested for use with Chemotherapy Drugs & Fentanyl CitrateIconic Medicare Sdn Bhd · 2023
  • K221648Iconic Latex GloveIconic Medicare Sdn Bhd · 2022
  • K212182Iconic Nitrile GloveIconic Medicare Sdn Bhd · 2021

All 3 as Iconic Medicare Sdn Bhd →

Other applicant names beginning “Iconic”

FDA records each applicant name separately; these may or may not be the same firm.

Iconic Solutions by Murcia, SL 1