510(k) Report

FDA applicant

Shanghai Changzheng Latex Factory

Sparks, NV1 decision1999–19990 recalls

FDA records 1 decision for Shanghai Changzheng Latex Factory (Sparks, NV) in 1999: 1 510(k) clearance. All are in product code LYY (Latex Patient Examination Glove). Its devices cite 1 predicate, 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 Shanghai Changzheng Latex Factory’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Shanghai Changzheng Latex Factory since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Shanghai Changzheng Latex Factory by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Shanghai Changzheng Latex Factory’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • LYYLatex Patient Examination Glove1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K992031Latex Examination Glove Powder Free, with Protein Labeling Claim (50 Micrograms or Less Total Water Soluble…Shanghai Changzheng Latex Factory · 1999

The one decision as Shanghai Changzheng Latex Factory →