510(k) Report

FDA applicant

Sri Trang Gloves (Thailand) Public Company Limited

Hatyai, TH8 decisions2020–20240 recalls

FDA records 8 decisions for Sri Trang Gloves (Thailand) Public Company Limited (Hatyai, TH) from 2020 to 2024: 8 510(k) clearances. Most are in product codes LZA (Polymer Patient Examination Glove) and LYY (Latex Patient Examination Glove). Since 2016 its 510(k)s took a median of 212 days from receipt to decision, against 101 for FDA’s reviews in the same codes and years. Its devices cite 1 predicate, 0 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Sri Trang Gloves Thailand (Public Company Limited)”.

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 Sri Trang Gloves (Thailand) Public Company Limited’s devices, and how often a recall has named them.

FDA decisions per year

3in 2024

2020: 22022: 32024: 3
2020high 3 (2022) · low 0 (2021)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2020.

FIG. 1 — Sri Trang Gloves (Thailand) Public Company Limited by year, 2020–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Sri Trang Gloves (Thailand) Public…’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 Glove5decisions
  • LYYLatex Patient Examination Glove3decisions

How long do its 510(k) reviews take?

Since 2016, its 7 510(k)s took a median of 212 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 101 days; 2 of its 7 were faster than that.

Whose devices does it build on?

Its devices cite 1 predicate; 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.

  • K193581Non-Sterile, Powder Free Nitrile Exam Glove Tested for use with Chemotherapy Drugs - Lilac, Non-Sterile…Sri Trang Gloves (Thailand) Public Company Limited · 20201cites it

What has FDA decided for it lately?

  • K240266Latex Examination Glove Powder Free (Ocean Blue and Natural White)Sri Trang Gloves (Thailand) Public Company Limited · 2024
  • K240930Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with 55 Chemotherapy Drugs and Fentanyl-…Sri Trang Gloves Thailand (Public Company Limited) · 2024
  • K232614Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with Chemotherapy Drugs and Fentanyl…Sri Trang Gloves (Thailand) Public Company Limited · 2024
  • K221165Non-Sterile, Powder-Free Nitrile Examination Glove Violet Blue Tested for use with Chemotherapy Drugs and…Sri Trang Gloves (Thailand) Public Company Limited · 2022
  • K212482Non-sterile, Powder-Free Latex Examination Glove Ocean Blue, Violet Blue, Black and Natural WhiteSri Trang Gloves (Thailand) Public Company Limited · 2022
  • K212309Non-sterile, Powder-Free Latex Examination GloveSri Trang Gloves (Thailand) Public Company Limited · 2022
  • K200539Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with Chemotherapy Drugs and FentanylSri Trang Gloves (Thailand) Public Company Limited · 2020
  • K193581Non-Sterile, Powder Free Nitrile Exam Glove Tested for use with Chemotherapy Drugs - Lilac, Non-Sterile…Sri Trang Gloves (Thailand) Public Company Limited · 2020

All 7 as Sri Trang Gloves (Thailand) Public Company Limited →The one decision as Sri Trang Gloves Thailand (Public Company Limited) →