510(k) Report

FDA applicant

Wilshire Technologies

San Diego, CA2 decisions1995–20020 recalls

FDA records 2 decisions for Wilshire Technologies (San Diego, CA) from 1995 to 2002: 2 510(k) clearances. All are in product code LZA (Polymer Patient Examination Glove). Its devices cite 8 predicates, 1 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 Wilshire Technologies’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Wilshire Technologies since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Wilshire Technologies 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?

  • LZAPolymer Patient Examination Glove2decisions

Whose devices does it build on?

Its devices cite 8 predicates; 1 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K950033PolydermWilshire Technologies · 19951cites it

What has FDA decided for it lately?

  • K022095Duraclean with Lycra Powder Free Polyurethane Medical Examination GloveWilshire Technologies · 2002
  • K950033PolydermWilshire Technologies · 1995

All 2 as Wilshire Technologies →

Other applicant names beginning “Wilshire”

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

Wilshire Medical Products 12