510(k) Report

FDA applicant

Sinochem Ningbo Imp & Exp Corp.

Green Valley, AZ1 decision1996–19960 recalls

FDA records 1 decision for Sinochem Ningbo Imp & Exp Corp. (Green Valley, AZ) in 1996: 1 510(k) clearance. All are in product code LYY (Latex 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 Sinochem Ningbo Imp & Exp Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Sinochem Ningbo Imp & Exp Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Sinochem Ningbo Imp & Exp 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?

  • LYYLatex Patient Examination Glove1decision

Who builds on its devices?

Later devices cite its devices 1 time; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K955918Sinochem Ningbo Latex Examination Glove, Powder FreeSinochem Ningbo Imp & Exp Corp. · 19961cites it

What has FDA decided for it lately?

  • K955918Sinochem Ningbo Latex Examination Glove, Powder FreeSinochem Ningbo Imp & Exp Corp. · 1996

The one decision as Sinochem Ningbo Imp & Exp Corp. →

Other applicant names beginning “Sinochem”

FDA records each applicant name separately; these may or may not be the same firm.

Sinochem (Usa), Inc. 14Sinochem Ningbo Latex Gloves Factory 1