510(k) Report

FDA applicant

Rubbercare Protection Products Sdn Bhd

Seremban, Negeri Sembilan, MY2 decisions2011–20110 recalls

FDA records 2 decisions for Rubbercare Protection Products Sdn Bhd (Seremban, Negeri Sembilan, MY) in 2011: 2 510(k) clearances. Most are in product codes LYY (Latex Patient Examination Glove) and LZA (Polymer Patient Examination Glove). Its devices cite 1 predicate, 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 Rubbercare Protection Products Sdn Bhd’s devices, and how often a recall has named them.

FDA decisions per year

2in 2011

2011: 2
2011high 2 (2011) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2011.

FIG. 1 — Rubbercare Protection Products Sdn Bhd by year, 2011–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • LYYLatex Patient Examination Glove1decision
  • LZAPolymer Patient Examination Glove1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K102902Rubbercare Powder Free Latex Examination Glove, Blue ColorRubbercare Protection Products Sdn Bhd · 2011
  • K103661Rubbercare Powder Free Nitrile Examination GloveRubbercare Protection Products Sdn Bhd · 2011

All 2 as Rubbercare Protection Products Sdn Bhd →