FDA applicant

Glove Seal Sdn Bhd

Kuala Lumpur, MY2 decisions1989–19990 recalls

FDA records 2 decisions for Glove Seal Sdn Bhd (Kuala Lumpur, MY) from 1989 to 1999: 2 510(k) clearances. All are in product code LYY (Latex 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 Glove Seal Sdn Bhd’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Glove Seal Sdn Bhd since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Glove Seal Sdn Bhd’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 “Glove”

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

Glove India Private, Ltd. 2 Glove India Pvt., Ltd. 2 Glove Lines Private, Ltd. 1 Glove Source, Inc. 1 Glove One, LLC 1 The Glove Outlet, Inc. 1

Glove Seal Sdn Bhd

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Glove”