510(k) Report

FDA applicant

Real Latex Pvt., Ltd.

Bombay, Maharashtra, IN2 decisions1989–19920 recalls

FDA records 2 decisions for Real Latex Pvt., Ltd. (Bombay, Maharashtra, IN) from 1989 to 1992: 2 510(k) clearances. Most are in product codes LYY (Latex Patient Examination Glove) and KGO (Surgeon'S Gloves). 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 Real Latex Pvt., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Real Latex Pvt., Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Real Latex 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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Other applicant names beginning “Real”

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