510(k) Report

FDA applicant

Nb Medical Co., Ltd.

Thai Binh Province, VN2 decisions2022–20240 recalls

FDA records 2 decisions for Nb Medical Co., Ltd. (Thai Binh Province, VN) from 2022 to 2024: 2 510(k) clearances. All are in product code LZA (Polymer Patient Examination Glove). Its devices cite 2 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Nb Medical 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 Nb Medical Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2022: 12024: 1
2022high 1 (2022) · low 0 (2023)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2022.

FIG. 1 — Nb Medical Co., Ltd. by year, 2022–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Nb Medical Co., Ltd.’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 Glove2decisions

Whose devices does it build on?

Its devices cite 2 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.

  • K220343Nitrile Examination GlovesNb Medical Co., Ltd. · 20221cites it

What has FDA decided for it lately?

  • K242812NITRILE EXAMINATION GLOVES (Tested For Use With Chemotherapy Drugs)Nb Medical Company Limited · 2024
  • K220343Nitrile Examination GlovesNb Medical Co., Ltd. · 2022

The one decision as Nb Medical Co., Ltd. →The one decision as Nb Medical Company Limited →