FDA applicant

Safeskin Corp.

San Diego, CA24 decisions1988–20000 recalls

FDA records 24 decisions for Safeskin Corp. (San Diego, CA) from 1988 to 2000: 24 510(k) clearances. Most are in product codes LYY (Latex Patient Examination Glove) and KGO (Surgeon'S Gloves). Its devices cite 1 predicate, 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 Safeskin Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Safeskin Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Safeskin Corp. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Safeskin Corp.’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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Other applicant names beginning “Safeskin”

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

Safeskin Retailing (Hk) Limited 4

Safeskin Corp.

Which product codes does it file in?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Safeskin”