510(k) Report

FDA applicant

Shanghai Cosmos Corp.

Great Neck,, NY2 decisions1999–19990 recalls

FDA records 2 decisions for Shanghai Cosmos Corp. (Great Neck,, NY) in 1999: 2 510(k) clearances. All are in product code LYZ (Vinyl 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 Shanghai Cosmos Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Shanghai Cosmos Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Shanghai Cosmos Corp. 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?

  • LYZVinyl Patient Examination Glove2decisions

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?

  • K992271Pre-Powdered Vinyl Patient Examination GlovesShanghai Cosmos Corp. · 1999
  • K992272Powder-Free Vinyl Patient Examination GlovesShanghai Cosmos Corp. · 1999

All 2 as Shanghai Cosmos Corp. →