FDA applicant

Platinum Glove Industries Sdn. Bhd.

Kuala Lumpur, MY6 decisions2005–20190 recalls

FDA records 6 decisions for Platinum Glove Industries Sdn. Bhd. (Kuala Lumpur, MY) from 2005 to 2019: 6 510(k) clearances. All are in product code 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 Platinum Glove Industries Sdn. Bhd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2019

2007high 1 (2008) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Platinum Glove Industries 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 “Platinum”

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

Platinum Services, Inc. 2 Platinum Team Co., Ltd. 1

Platinum Glove Industries Sdn. Bhd.

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Platinum”