510(k) Report

FDA applicant

Best Putra Gloves Sdn Bhd

Sg Choh Rawang, Selangor, MY4 decisions2010–20100 recalls

FDA records 4 decisions for Best Putra Gloves Sdn Bhd (Sg Choh Rawang, Selangor, MY) in 2010: 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 Best Putra Gloves Sdn Bhd’s devices, and how often a recall has named them.

FDA decisions per year

4in 2010

2010: 4
2010high 4 (2010) · low 0 (2011)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2010.

FIG. 1 — Best Putra Gloves Sdn Bhd by year, 2010–2026Sources: 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?

  • K101105Powder-Free, Natural Color, Latex Examination Glove Model: MEPF1Best Putra Gloves Sdn Bhd · 2010
  • K101106Powdered, Natural Color, Latex Examination Glove Model: MEP1Best Putra Gloves Sdn Bhd · 2010
  • K101103Powdered, Natural Color, Latex Surgical Glove, Sterile Model: MSP1Best Putra Gloves Sdn Bhd · 2010
  • K101102Powder-Free, Natural Color, Latex Surgical Glove, SterileBest Putra Gloves Sdn Bhd · 2010

All 4 as Best Putra Gloves Sdn Bhd →