510(k) Report

FDA applicant

Hl Rubber Industries Sdn Bhd

Kuala Pilah, Negeri Sembilan, MY7 decisions2007–20220 recalls

FDA records 7 decisions for Hl Rubber Industries Sdn Bhd (Kuala Pilah, Negeri Sembilan, MY) from 2007 to 2022: 7 510(k) clearances. Most are in product codes LZA (Polymer Patient Examination Glove) and LZC (Medical Glove, Specialty). 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 Hl Rubber Industries Sdn Bhd’s devices, and how often a recall has named them.

FDA decisions per year

1in 2022

2007: 22010: 12013: 12014: 22022: 1
2007high 2 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Hl Rubber Industries 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?

  • LZAPolymer Patient Examination Glove6decisions
  • LZCMedical Glove, Specialty1decision

Who builds on its devices?

Later devices cite its devices 1 time; 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.

  • K063522Powder Nitrile Examination Glove (White and Blue Color)Hl Rubber Industries Sdn Bhd · 20071cites it

What has FDA decided for it lately?

  • K220545Powder Free Nitrile Examination Gloves, Blue, Tested for use with Chemotherapy DrugsHl Rubber Industries Sdn Bhd · 2022
  • K141021Powder-Free Nitrile Examination Gloves, Orange, ColorHl Rubber Industries Sdn Bhd · 2014
  • K140316Examination GlovesHl Rubber Industries Sdn Bhd · 2014
  • K130038Powder-Free Nitrile Examination Gloves, BlueHl Rubber Industries Sdn Bhd · 2013
  • K100369Powder-Free Nitrile Gloves, BlackHl Rubber Industries Sdn Bhd · 2010
  • K063522Powder Nitrile Examination Glove (White and Blue Color)Hl Rubber Industries Sdn Bhd · 2007
  • K063524Powder Free Nitrile Examination Gloves (White and Blue Color)Hl Rubber Industries Sdn Bhd · 2007

All 7 as Hl Rubber Industries Sdn Bhd →