510(k) Report

FDA applicant

Ningbo Tianshun Rubber Products Co., Ltd.

Sparks, NV1 decision2002–20020 recalls

FDA records 1 decision for Ningbo Tianshun Rubber Products Co., Ltd. (Sparks, NV) in 2002: 1 510(k) clearance. All are in product code LZA (Polymer Patient Examination Glove). Its devices cite 2 predicates, 0 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 Ningbo Tianshun Rubber Products Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Ningbo Tianshun Rubber Products Co., Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Ningbo Tianshun Rubber Products Co., Ltd. by year, 2007–2026Sources: 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

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K023702Powder-Free Nitrile Exam Gloves, Color: BlueNingbo Tianshun Rubber Products Co., Ltd. · 2002

The one decision as Ningbo Tianshun Rubber Products Co., Ltd. →