510(k) Report

FDA applicant

Vietglove Corporation

Bau Bang Province, VN4 decisions2016–20210 recalls

FDA records 4 decisions for Vietglove Corporation (Bau Bang Province, VN) from 2016 to 2021: 4 510(k) clearances. Most are in product codes LYY (Latex Patient Examination Glove) and LZA (Polymer Patient Examination Glove). Since 2016 its 510(k)s took a median of 137 days from receipt to decision, against 157 for FDA’s reviews in the same codes and years. Its devices cite 1 predicate, 1 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 Vietglove Corporation’s devices, and how often a recall has named them.

FDA decisions per year

1in 2021

2016: 22017: 12021: 1
2016high 2 (2016) · low 0 (2018)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2016.

FIG. 1 — Vietglove Corporation by year, 2016–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Vietglove Corporation’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?

  • LYYLatex Patient Examination Glove2decisions
  • LZAPolymer Patient Examination Glove2decisions

How long do its 510(k) reviews take?

Since 2016, its 4 510(k)s took a median of 137 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 157 days; 3 of its 4 were faster than that.

Who builds on its devices?

Later devices cite its devices 4 times; 1 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.

  • K153562Powder Free Blue Nitrile Examination GloveVietglove Corporation · 20163cite it
  • K201428Powder Free Black Nitrile Examination GloveVietglove Corporation · 20211cites it

What has FDA decided for it lately?

  • K201428Powder Free Black Nitrile Examination GloveVietglove Corporation · 2021
  • K170094Powder Free Latex Examination Glove, Polymer CoatedVietglove Corporation · 2017
  • K162175Powder Free Latex Examination Glove with Protein Labeling Claim of 50ug/dm2 or lessVietglove Corporation · 2016
  • K153562Powder Free Blue Nitrile Examination GloveVietglove Corporation · 2016

All 4 as Vietglove Corporation →