510(k) Report

FDA applicant

Fitco Dipped Products Pvt., Ltd.

Kerala, IN6 decisions1999–20000 recalls

FDA records 6 decisions for Fitco Dipped Products Pvt., Ltd. (Kerala, IN) from 1999 to 2000: 6 510(k) clearances. Most are in product codes LYY (Latex Patient Examination Glove) and KGO (Surgeon'S Gloves). 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 Fitco Dipped Products Pvt., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Fitco Dipped Products Pvt., Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Fitco Dipped Products Pvt., 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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