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

Aladan Corp. — Predicate Candidate Screening

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

43 daysmedian FDA review time

262 days90th percentile

18clearances measured

K-number	Device	Applicant	Decided	Review days
K960590	TRI-CLEAN 110/TRI-CLEAN PLUS GLOVE	Aladan Corp.	1996-10-31	262
K952404	SAFETEX SUPER HYPERALLERGENIC POWDERFREE LATEX MEDICAL GLOVE	Aladan Corp.	1995-07-20	59
K952556	SAFETEX SUPER HYPOALLERGENIC POWDERED LATEX EXAMINATION GLOV	Aladan Corp.	1995-06-26	24
K943933	SAXON GOLD ULTRA SPERMICIDAL RAINBOW CONDOM	Aladan Corp.	1995-06-22	314
K951839	ALADAN HYPOALLERGENIC LATEX MEDICAL EXAMINATION GLOVES	Aladan Corp.	1995-06-15	56
K943883	SAXON GOLD ULTRA SPERMICIDAL RAINBOW CONDOM	Aladan Corp.	1995-04-14	248
K942758	HYPOALLERGEN NON-STER POWDERFREE LATEX PAT EXAM GLOVE	Aladan Corp.	1994-07-08	25
K940873	SAFETEX HYPOALLERGENIC POWDERFREE LATEX EXAMINATION GLOVE	Aladan Corp.	1994-04-22	56
K911774	ALADAN LATEX MEDICAL GLOVE	Aladan Corp.	1991-05-03	14
K911447	LATEX EXAMINATION GLOVES (HYPOALLERGENIC)	Aladan Corp.	1991-04-16	39
K905279	CONDOM (RUBBER) CONTRACEPTIVE	Aladan Corp.	1991-02-19	88
K905678	ALADERM	Aladan Corp.	1991-01-18	30
K902565	ALADAN TRI-CLEAN 110 POWDERLESS LATEX GLOVE	Aladan Corp.	1990-07-03	22
K901416	CONDOM (RUBBER) CONTRACEPTIVE	Aladan Corp.	1990-06-04	70
K902181	MODIFIED NON-STERILE LATEX EXAMINATION GLOVES	Aladan Corp.	1990-06-01	30
K902182	MODIFIED STERILE LATEX EXAMINATION GLOVES	Aladan Corp.	1990-06-01	30
K890880	ALADAN STERILE LATEX MEDICAL GLOVE	Aladan Corp.	1989-03-29	36
K890627	UNSTERILE PATIENT EXAMINATION GLOVE	Aladan Corp.	1989-03-23	43

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