Ansell, Inc.

Dothan, AL, US

Ansell, Inc. appears in FDA device records in Dothan, AL. FDA records list 30 510(k) clearances between 1980-12-11 and 1999-07-21, no PMA records and no registered establishments. As of 2026-09-10, FDA records show no recalls for this company.

510(k) clearances: 30
PMA records: 0
Recall records: 0
Registered establishments: 0

510(k) clearance history

FDA records hold 30 510(k) clearances for Ansell, Inc. between 1980 and 1999. The busiest year on record is 1990, with 6. The most recent is 1999, with 2.

Clearances by year, as a table

510(k) clearance decisions for Ansell, Inc., by decision year
Year	Clearances
1980	1
1982	2
1983	3
1985	1
1987	2
1988	1
1989	4
1990	6
1992	1
1993	1
1995	6
1999	2

510(k) clearances on record, most recent first
K number	Device	Product code	Decision	Decision date
K984392	ANSELL CONDOMS	HIS	Substantially Equivalent	1999-07-21
K983518	LIFESTYLES XTRA PLEASURE	HIS	Substantially Equivalent	1999-07-06
K940047	SPERMICIDALLY LUBRICATED CONDOM	HIS	Substantially Equivalent	1995-12-19
K953379	HYPOALLERGENIC POWDERED AMBIDEXTROUS COAGULATN DIPPED LATEX EXAMINATION GLOVE	LYY	Substantially Equivalent	1995-09-27
K945766	HYPOALLERGENIC POWDERED AMBIDEXTROUS PATIENT EXAMINATION GLOVES	LYY	Substantially Equivalent	1995-08-07
K945767	POWDER FREE, HYPOALLERGENIC AMBIDEXTROUS PATIENT EXAMINATION GLOVES	LYY	Substantially Equivalent	1995-03-02
K940046	NON-LUBRICATED CONDOM	HIS	Substantially Equivalent	1995-01-30
K940045	CONDOM	HIS	Substantially Equivalent	1995-01-30
K913766	ANSELL NO POWDER AMBI PATIENT EXAMINATION GLOVES	LYY	Substantially Equivalent	1993-03-11
K914760	LATEX EXAMINATION GLOVES	LYY	Substantially Equivalent	1992-01-17
K903108	PATIENT EXAM GLOVES (FINISH W/USP STARCH POWDER)	LYY	Substantially Equivalent	1990-08-29
K903107	PATIENT EXAM GLOVES (DUSTED W/USP STARCH POWDER)	LYY	Substantially Equivalent	1990-08-29
K901112	G.S.A. COLORED CONDOMS	HIS	Substantially Equivalent	1990-03-27
K901111	NUDA (CURRENTLY CALLED ULTRA SENSITIVE)	HIS	Substantially Equivalent	1990-03-27
K897081	ANSELL CONFORM GREEN EXAMINATION GLOVES	LYZ	Substantially Equivalent	1990-03-26
K895660	ANSELL DENTA GLOVES	LYY	Substantially Equivalent	1990-01-02
K892289	PATIENT EXAMINATION GLOVES (LATEX)	LYY	Substantially Equivalent	1989-06-23
K892288	PATIENT EXAMINATION GLOVES (LATEX)	LYY	Substantially Equivalent	1989-06-09
K892325	NON-STERILE EXAM GLOVES	LYY	Substantially Equivalent	1989-05-31
K892106	STERILE EXAM GLOVES	LYY	Substantially Equivalent	1989-05-31
K882389	KISS OF MINT(TM) NON-LUBRICATED CONDOM	HIS	Substantially Equivalent	1988-10-20
K871304	LIFESTYLES EXTRA STRENGTH CONDOMS W/NONOXYNOL-9	HIS	Substantially Equivalent	1987-06-11
K864400	EXTRA STRONG CONDOM	HIS	Substantially Equivalent	1987-02-02
K850635	ANSELL NO POWDER SURGEON'S GLOVES	KGO	Substantially Equivalent	1985-06-26
K831565	MICRO-THIN SURGICAL GLOVE	KGO	Substantially Equivalent	1983-07-19
K831564	ORTHOPEDIC SURGICAL GLOVE	FMC	Substantially Equivalent	1983-07-12
K830691	PRIME	HIS	Substantially Equivalent	1983-03-31
K822792	NUDA-PLUS CONDOM W/SPERMICIDAL LUBRICANT	HIS	Substantially Equivalent	1982-09-30
K820665	DERMA PRENE	KGO	Substantially Equivalent	1982-05-03
K802641	GAMMEX SURGICAL GLOVES	KGO	Substantially Equivalent	1980-12-11

Registered establishments

No FDA establishment registrations recorded against this company.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

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What MDM checks, and what it does not

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Data as of 2026-09-28, FDA export datePage updated 2026-09-05Source: openFDA, public domain