510(k) Report

FDA applicant

W.A. Rubbermate Co., Ltd.

Scottsdale, AZ4 decisions1997–20240 recalls

FDA records 4 decisions for W.A. Rubbermate Co., Ltd. (Scottsdale, AZ) from 1997 to 2024: 4 510(k) clearances. Most are in product codes LYY (Latex Patient Examination Glove) and LZA (Polymer 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 W.A. Rubbermate Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2011: 12024: 1
2007high 1 (2011) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like W.A. Rubbermate 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?

  • LYYLatex Patient Examination Glove2decisions
  • LZAPolymer Patient Examination Glove2decisions

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?

  • K233740Black Nitrile Powder Free Patient Examination Glove, Non SterileW.A. Rubbermate Co., Ltd. · 2024
  • K110418Powder Free Nitrile Examination GlovesW.A. Rubbermate Co., Ltd. · 2011
  • K021041WA Rubbermate Latex Powder-Free Exam GlovesW.A. Rubbermate Co., Ltd. · 2002
  • K971200W.A.W.A. Rubbermate Co., Ltd. · 1997

All 4 as W.A. Rubbermate Co., Ltd. →