Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Pan-Century Rubber Products Sdn. Bhd. — Predicate Candidate Screening

9 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

28 daysmedian FDA review time

195 days90th percentile

9clearances measured

K-number	Device	Applicant	Decided	Review days
K993183	POWDER FREE GLOVES (POLYMER COATED)	Pan-Century Rubber Products Sdn. Bhd.	1999-11-19	57
K993287	POWDER FREE (SILICON COATED) LATEX EXAMINATION GLOVES WITH P	Pan-Century Rubber Products Sdn. Bhd.	1999-10-29	28
K981164	POWDER FREE CHLORINATED GLOVES-(TEXTURED)	Pan-Century Rubber Products Sdn. Bhd.	1998-04-23	23
K955241	HIGH RISK GLOVES	Pan-Century Rubber Products Sdn. Bhd.	1996-05-28	195
K924633	HYPOALLERGENIC LATEX GLOVES	Pan-Century Rubber Products Sdn. Bhd.	1993-01-27	141
K910045	PATIENT EXAMINATION GLOVES-POWDER FREED	Pan-Century Rubber Products Sdn. Bhd.	1991-01-15	11
K910046	PATIENT EXAMINATION GLOVES-ANATOMICAL GLOVES	Pan-Century Rubber Products Sdn. Bhd.	1991-01-15	11
K910047	PATIENT EXAMINATION GLOVES-TEXTURED GLOVES	Pan-Century Rubber Products Sdn. Bhd.	1991-01-15	11
K894375	PATIENT EXAMINATION GLOVES	Pan-Century Rubber Products Sdn. Bhd.	1989-09-21	66

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda