510(k) Report

FDA applicant

Shanghai Super Gloves Co., Ltd.

Great Neck,, NY2 decisions1997–19970 recalls

FDA records 2 decisions for Shanghai Super Gloves Co., Ltd. (Great Neck,, NY) in 1997: 2 510(k) clearances. All are in product code LYZ (Vinyl Patient Examination Glove). Its devices cite 4 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 Super Gloves Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Shanghai Super Gloves Co., Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Shanghai Super Gloves Co., Ltd. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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

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Which product codes does it file in?

  • LYZVinyl Patient Examination Glove2decisions

Whose devices does it build on?

Its devices cite 4 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 8 times; 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.

  • K974151Vinyl Patient Examination Gloves (Powdered)Shanghai Super Gloves Co., Ltd. · 19976cite it
  • K974120Powder-Free Vinyl Patient Examination GlovesShanghai Super Gloves Co., Ltd. · 19972cite it

What has FDA decided for it lately?

  • K974151Vinyl Patient Examination Gloves (Powdered)Shanghai Super Gloves Co., Ltd. · 1997
  • K974120Powder-Free Vinyl Patient Examination GlovesShanghai Super Gloves Co., Ltd. · 1997

All 2 as Shanghai Super Gloves Co., Ltd. →