510(k) Report

FDA applicant

Vrg Khai Hoan Joint Stock Company

Ben Cat District,, VN1 decision2015–20151 recall

FDA records 1 decision for Vrg Khai Hoan Joint Stock Company (Ben Cat District,, VN) in 2015: 1 510(k) clearance. All are in product code LZA (Polymer Patient Examination Glove). 1 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 Vrg Khai Hoan Joint Stock Company’s devices, and how often a recall has named them.

FDA decisions per year

1in 2015

2015: 1
2015high 1 (2015) · low 0 (2016)2026

2026 so far, outlined.

Recalls per year

1in 2020

2020: 1
2015high 1 (2020) · low 0 (2015)2026

Class I Class II/III not classified

FIG. 1 — Vrg Khai Hoan Joint Stock Company by year, 2015–2026Sources: 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 Glove1decision

What has FDA decided for it lately?

  • K151208Powder Free Nitrile Examination GloveVrg Khai Hoan Joint Stock Company · 20151 recall

The one decision as Vrg Khai Hoan Joint Stock Company →

What has been recalled?

1 recall linked to its devices; the latest:

  • K151208VGlove NITRILE *** Protect Your Life 100 Patient examination glovesOct 23, 2020Class II