510(k) Report

FDA applicant

Assurguard Sdn. Bhd.

Selangor Darul Ehsan, MY2 decisions2013–20130 recalls

FDA records 2 decisions for Assurguard Sdn. Bhd. (Selangor Darul Ehsan, MY) in 2013: 2 510(k) clearances. Most are in product codes LZA (Polymer Patient Examination Glove) and LYY (Latex Patient Examination Glove). Its devices cite 2 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 Assurguard Sdn. Bhd.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2013

2013: 2
2013high 2 (2013) · low 0 (2014)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2013.

FIG. 1 — Assurguard Sdn. Bhd. by year, 2013–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • LZAPolymer Patient Examination Glove1decision
  • LYYLatex Patient Examination Glove1decision

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K123757Powder Free Latex Patient Examination Gloves, with Protein Content Labeling Claim, Natural ColorAssurguard Sdn. Bhd. · 2013
  • K123760Multiple NameAssurguard Sdn. Bhd. · 2013

All 2 as Assurguard Sdn. Bhd. →