510(k) Report

FDA applicant

Nitrilist Gloves Manufacturing Sdn Bhd

Kuala Pilah, MY2 decisions2012–20130 recalls

FDA records 2 decisions for Nitrilist Gloves Manufacturing Sdn Bhd (Kuala Pilah, MY) from 2012 to 2013: 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 Nitrilist Gloves Manufacturing Sdn Bhd’s devices, and how often a recall has named them.

FDA decisions per year

1in 2013

2012: 12013: 1
2012high 1 (2012) · low 0 (2014)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2012.

FIG. 1 — Nitrilist Gloves Manufacturing Sdn Bhd by year, 2012–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Nitrilist Gloves Manufacturing Sdn Bhd’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • LZAPolymer Patient Examination Glove2decisions

What has FDA decided for it lately?

  • K123328Powder Free Nitrile Examination Gloves, Blue and BlackNitrilist Gloves Manufacturing Sdn Bhd · 2013
  • K122874Powdered Nitrile Examination Gloves, Blue and WhiteNitrilist Gloves Manufacturing Sdn Bhd · 2012

All 2 as Nitrilist Gloves Manufacturing Sdn Bhd →