FDA applicant
Comfort Rubber Gloves Industries Sdn. Bhd.
FDA records 15 decisions for Comfort Rubber Gloves Industries Sdn. Bhd. (Matang, MY) from 1994 to 2025: 15 510(k) clearances. Most are in product codes LZA (Polymer Patient Examination Glove) and LYY (Latex Patient Examination Glove). Since 2016 its 510(k)s took a median of 140 days from receipt to decision, against 103 for FDA’s reviews in the same codes and years. Its devices cite 9 predicates, 2 of them its own earlier devices. 1 recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Comfort Rubber Gloves Industries Sdn. Bhd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2025
2026 so far, outlined.
Recalls per year
1in 2020
Class I Class II/III not classified
Planning a device like Comfort Rubber Gloves Industries Sdn.…’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) ReportOther applicant names beginning “Comfort”
FDA records each applicant name separately; these may or may not be the same firm.