FDA applicant

Polar Latex, Ltd.

Julian, CA1 decision1996–19960 recalls

FDA records 1 decision for Polar Latex, Ltd. (Julian, CA) in 1996: 1 510(k) clearance. All are in product code HIS (Condom). 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, obstetrics and gynecology panel, where it files most

How often FDA has decided Polar Latex, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Polar Latex, Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Polar”

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

Polar Wrap, LLC 1

Polar Latex, Ltd.

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Polar”