510(k) Report

FDA applicant

Profit Point Manufacturing Sdn Bhd

Kluang, Johor, MY2 decisions2010–20120 recalls

FDA records 2 decisions for Profit Point Manufacturing Sdn Bhd (Kluang, Johor, MY) from 2010 to 2012: 2 510(k) clearances. All are in product code LZA (Polymer 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 Profit Point Manufacturing Sdn Bhd’s devices, and how often a recall has named them.

FDA decisions per year

1in 2012

2010: 12012: 1
2010high 1 (2010) · low 0 (2011)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2010.

FIG. 1 — Profit Point Manufacturing 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?

  • LZAPolymer Patient Examination Glove2decisions

What has FDA decided for it lately?

  • K120110Elegant Nitrile Powder Free Examination Glove Blue VioletProfit Point Manufacturing Sdn Bhd · 2012
  • K101760Elegant Blue, White, Pink Powder Free, Nitrile Examination GlovesProfit Point Manufacturing Sdn Bhd · 2010

All 2 as Profit Point Manufacturing Sdn Bhd →