510(k) Report

FDA applicant

Kanglongda Vietnam Protection Technology Company Limited

Thua Thien Hue, VN3 decisions2021–20260 recalls

FDA records 3 decisions for Kanglongda Vietnam Protection Technology Company Limited (Thua Thien Hue, VN) from 2021 to 2026: 3 510(k) clearances. All are in product code LZA (Polymer Patient Examination Glove). Since 2016 its 510(k)s took a median of 195 days from receipt to decision, against 103 for FDA’s reviews in the same codes and years. Its devices cite 3 predicates, 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 Kanglongda Vietnam Protection Technology Company Limited’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2021: 12024: 12026 (partial year): 1
2021high 1 (2021) · low 0 (2022)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2021.

FIG. 1 — Kanglongda Vietnam Protection Technology Company Limited by year, 2021–2026Sources: 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 Glove3decisions

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 195 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 103 days; 1 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 3 predicates; 1 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K202356Powder free Nitrile Examination Gloves (Blue, Violet Blue, White, Cobalt Blue)Kanglongda Vietnam Protection Technology Company Limited · 20211cites it

What has FDA decided for it lately?

  • K253824Powder Free Nitrile Examination Gloves Non-Sterile BlackKanglongda Vietnam Protection Technology Company Limited · 2026
  • K241970Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate…Kanglongda Vietnam Protection Technology Company Limited · 2024
  • K202356Powder free Nitrile Examination Gloves (Blue, Violet Blue, White, Cobalt Blue)Kanglongda Vietnam Protection Technology Company Limited · 2021

All 3 as Kanglongda Vietnam Protection Technology Company Limited →