510(k) Report

FDA applicant

Onetexx Sdn Bhd

Kamunting, MY7 decisions2021–20220 recalls

FDA records 7 decisions for Onetexx Sdn Bhd (Kamunting, MY) from 2021 to 2022: 7 510(k) clearances. All are in product code LZA (Polymer Patient Examination Glove). Since 2016 its 510(k)s took a median of 88 days from receipt to decision, against 111 for FDA’s reviews in the same codes and years. Its devices cite 4 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 Onetexx Sdn Bhd’s devices, and how often a recall has named them.

FDA decisions per year

3in 2022

2021: 42022: 3
2021high 4 (2021) · low 0 (2023)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2021.

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

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

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Which product codes does it file in?

  • LZAPolymer Patient Examination Glove7decisions

How long do its 510(k) reviews take?

Since 2016, its 7 510(k)s took a median of 88 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 111 days; 5 of its 7 were faster than that.

Whose devices does it build on?

Its devices cite 4 predicates; 0 are its own earlier devices. The firms it cites most:

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.

  • K210366Blue Nitrile Powder Free Patient Examination Glove, Non SterileOnetexx Sdn Bhd · 20211cites it

What has FDA decided for it lately?

  • K222298Violet Nitrile Powder Free Patient Examination Glove, Non-Sterile, Tested for Use With Chemotherapy Drugs…Onetexx Sdn Bhd · 2022
  • K222294Black Nitrile Powder Free Patient Examination Glove, Non-Sterile, Tested for Use With Chemotherapy Drugs…Onetexx Sdn Bhd · 2022
  • K221773Blue Nitrile Powder Free Patient Examination Glove, Non-Sterile, Tested For Use With the Opioid Fentanyl…Onetexx Sdn Bhd · 2022
  • K210588Black Nitrile Powder Free Patient Examination Glove, Non SterileOnetexx Sdn Bhd · 2021
  • K210587Violet Nitrile Powder Free Patient Examination Glove, Non SterileOnetexx Sdn Bhd · 2021
  • K210775White Nitrile Powder Free Patient Examination Glove, Non SterileOnetexx Sdn Bhd · 2021
  • K210366Blue Nitrile Powder Free Patient Examination Glove, Non SterileOnetexx Sdn Bhd · 2021

All 7 as Onetexx Sdn Bhd →