510(k) Report

FDA applicant

Evergrade Healthcare Products Sdn Bhd

Muar Johor, MY3 decisions1994–19980 recalls

FDA records 3 decisions for Evergrade Healthcare Products Sdn Bhd (Muar Johor, MY) from 1994 to 1998: 3 510(k) clearances. All are in product code LYY (Latex 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 Evergrade Healthcare Products Sdn Bhd’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Evergrade Healthcare Products Sdn Bhd since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Evergrade Healthcare Products Sdn Bhd by year, 2007–2026Sources: 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 Glove3decisions

Whose devices does it build on?

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

Who builds on its devices?

Later devices cite its devices 1 time; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K973664Latex Exam Glove, Powder-Free W/Protein & Hypoallergenic LabelingEvergrade Healthcare Products Sdn Bhd · 19981cites it

What has FDA decided for it lately?

  • K973664Latex Exam Glove, Powder-Free W/Protein & Hypoallergenic LabelingEvergrade Healthcare Products Sdn Bhd · 1998
  • K942855Non-Chlorinated Powder Free Latex Examination GlovesEvergrade Healthcare Products Sdn Bhd · 1995
  • K932116Patient Examination Gloves (Powder Free)Evergrade Healthcare Products Sdn Bhd · 1994

All 3 as Evergrade Healthcare Products Sdn Bhd →