510(k) Report

FDA applicant

Supergrade Healthcare Products Sdn. Bhd.

Sparks, NV3 decisions1989–20020 recalls

FDA records 3 decisions for Supergrade Healthcare Products Sdn. Bhd. (Sparks, NV) from 1989 to 2002: 3 510(k) clearances. Most are in product codes LYY (Latex Patient Examination Glove) and FMC (Patient Examination Glove). 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 Supergrade Healthcare Products Sdn. Bhd.’s devices, and how often a recall has named them.

FDA decisions per year

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

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Supergrade 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 Glove2decisions
  • FMCPatient Examination Glove1decision

Who builds on its devices?

Later devices cite its devices 2 times; 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.

  • K014134Powder-Free Latex Exam Gloves with Protein Labeling (<50UG/G)Supergrade Healthcare Products Sdn. Bhd. · 20022cite it

What has FDA decided for it lately?

  • K014134Powder-Free Latex Exam Gloves with Protein Labeling (<50UG/G)Supergrade Healthcare Products Sdn. Bhd. · 2002
  • K934133Patient Examination Gloves (Powder Free Gloves)Supergrade Healthcare Products Sdn. Bhd. · 1994
  • K891232Patient Examination GlovesSupergrade Healthcare Products Sdn. Bhd. · 1989

All 3 as Supergrade Healthcare Products Sdn. Bhd. →