510(k) Report

FDA applicant

Ssn Gloves (M) Sdn Bhd

Petaling Jaya, Selangor, MY4 decisions1999–20010 recalls

FDA records 4 decisions for Ssn Gloves (M) Sdn Bhd (Petaling Jaya, Selangor, MY) from 1999 to 2001: 4 510(k) clearances. Most are in product codes KGO (Surgeon'S Gloves) and LYY (Latex 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 and plastic surgery panel, where it files most

How often FDA has decided Ssn Gloves (M) Sdn Bhd’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Ssn Gloves (M) Sdn Bhd since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Ssn Gloves (M) 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?

  • KGOSurgeon'S Gloves2decisions
  • LYYLatex Patient Examination Glove2decisions

What has FDA decided for it lately?

  • K012896Sterile Powdered Latex Surgical Gloves with Protein Labeling Claim (200 Micrograms or Less)Ssn Gloves (M) Sdn Bhd · 2001
  • K012880Sterile Powder-Free Latex Surgical Gloves (50 Micrograms or Less)Ssn Gloves (M) Sdn Bhd · 2001
  • K990527Kleenhands Powdered Latex Examination GlovesSsn Gloves (M) Sdn Bhd · 1999
  • K990526Kleenhands Powderfree Latex Examination Gloves with Protein Labeling ClaimSsn Gloves (M) Sdn Bhd · 1999

All 4 as Ssn Gloves (M) Sdn Bhd →