510(k) Report

FDA applicant

Contract Latex Dippers Sdn Bhd

Kuala Lumpur, MY5 decisions1994–20010 recalls

FDA records 5 decisions for Contract Latex Dippers Sdn Bhd (Kuala Lumpur, MY) from 1994 to 2001: 5 510(k) clearances. Most are in product codes LYY (Latex Patient Examination Glove) and LZA (Polymer Patient Examination Glove). 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 Contract Latex Dippers Sdn Bhd’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Contract Latex Dippers Sdn Bhd since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Contract”

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