FDA applicant

Comfort Rubber Gloves Ind. Sdn. Bhd.

Taiping, Perak, MY2 decisions2009–20090 recalls

FDA records 2 decisions for Comfort Rubber Gloves Ind. Sdn. Bhd. (Taiping, Perak, MY) in 2009: 2 510(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 Comfort Rubber Gloves Ind. Sdn. Bhd.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2009

2009high 2 (2009) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2009.

FIG. 1 — Comfort Rubber Gloves Ind. Sdn. Bhd. by year, 2009–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Comfort Rubber Gloves Ind. 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 “Comfort”

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

Comfort Rubber Gloves Industries Sdn. Bhd. 15 Comfort Orthopedic Co., Ltd. 13 Comfort Acrylics Co. 3 Comfort Strap Co. 1 Comfort and Flexible Systems 1

Comfort Rubber Gloves Ind. Sdn. Bhd.

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Comfort”