FDA applicant

Great Glove Sdn Bhd

Kapar, Selangor D.E., MY4 decisions1999–20060 recalls

FDA records 4 decisions for Great Glove Sdn Bhd (Kapar, Selangor D.E., MY) from 1999 to 2006: 4 510(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 Great Glove Sdn Bhd’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Great Glove Sdn Bhd since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Great Glove 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 “Great”

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

Great Lakes Orthodontics, Ltd. 13 Great Batch Medical 11 Great Basin Scientific, Inc. 4 Great Glove (China), Inc. 2 Great Eastern Lumber Co., Inc. 2 Great Glove (Thailand) Co., Ltd. 2 Great Field Industries Co., Ltd. 1 Great Eco Glove Sdn. Bhd. 1 Great Future Works, Ltd. 1 Great Lakes Intl. 1 Great West Medical Equipment, Inc. 1 Great Bay Medical Products, Inc. 1

Great Glove Sdn Bhd

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Great”