FDA applicant

Glovco (M) Sdn. Bhd.

Klang, Selangor D.E., MY9 decisions1999–20050 recalls

FDA records 9 decisions for Glovco (M) Sdn. Bhd. (Klang, Selangor D.E., MY) from 1999 to 2005: 9 510(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 Glovco (M) Sdn. Bhd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Glovco (M) Sdn. Bhd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Glovco (M) Sdn. Bhd. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Glovco (M) Sdn. Bhd.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Other applicant names beginning “Glovco”

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

Glovco Malaysia Sdn Bhd 3

Glovco (M) Sdn. Bhd.

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Glovco”