510(k) Report

FDA applicant

Premier Medical Gloves Factory

Weifang, Shandong, CN1 decision2011–20110 recalls

FDA records 1 decision for Premier Medical Gloves Factory (Weifang, Shandong, CN) in 2011: 1 510(k) clearance. All are in product code LYZ (Vinyl Patient Examination Glove). 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 Premier Medical Gloves Factory’s devices, and how often a recall has named them.

FDA decisions per year

1in 2011

2011: 1
2011high 1 (2011) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2011.

FIG. 1 — Premier Medical Gloves Factory by year, 2011–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • LYZVinyl Patient Examination Glove1decision

What has FDA decided for it lately?

  • K111297Synthetic Vinyl Examination Gloves, Powder Free (and Multiple Labels)Premier Medical Gloves Factory · 2011

The one decision as Premier Medical Gloves Factory →