510(k) Report

FDA applicant

Pentavest Holdings Sdn Bhd

Batu, MY2 decisions2021–20220 recalls

FDA records 2 decisions for Pentavest Holdings Sdn Bhd (Batu, MY) from 2021 to 2022: 2 510(k) clearances. Most are in product codes LZA (Polymer Patient Examination Glove) and KGO (Surgeon'S Gloves). Its devices cite 2 predicates, 0 of them its own earlier devices. 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 Pentavest Holdings Sdn Bhd’s devices, and how often a recall has named them.

FDA decisions per year

1in 2022

2021: 12022: 1
2021high 1 (2021) · low 0 (2023)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2021.

FIG. 1 — Pentavest Holdings Sdn Bhd by year, 2021–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Pentavest Holdings 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 Glove1decision
  • KGOSurgeon'S Gloves1decision

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 times; 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.

  • K212848Sterile Latex Surgical Gloves Powder FreePentavest Holdings Sdn Bhd · 20212cite it

What has FDA decided for it lately?

  • K212847Penta GlovePentavest Holdings Sdn Bhd · 2022
  • K212848Sterile Latex Surgical Gloves Powder FreePentavest Holdings Sdn Bhd · 2021

All 2 as Pentavest Holdings Sdn Bhd →