Medical Device Manufacturer · US , Avondale , AZ

Suretex, Ltd. - FDA 510(k) Cleared Devices

5 submissions · 5 cleared · Since 1991

5

Total

5

Cleared

0

Denied

FDA 510(k) Regulatory Record - Suretex, Ltd. Obstetrics & Gynecology ✕

5 devices

1-5 of 5

Cleared Apr 17, 2003

LIFESTYLES, CONTEMPO OR PRIVATE LABEL-MALE LATEX CONDOM WITH DESENSITIZING...

Obstetrics & Gynecology · 90d

Cleared Apr 27, 2001

LIFESTYLES, CONTEMPO OR PRIVATE LABEL, MALE LATEX CONDOM WITH GLYCERINE...

Obstetrics & Gynecology · 79d

Cleared Dec 06, 1995

Obstetrics & Gynecology · 630d

Cleared May 18, 1995

LATEX CONDOMS W/SPERMICIDAL LUBRICANT (NONOXYNOL-9)

Obstetrics & Gynecology · 428d

Cleared Jun 04, 1991

CONDOMS (RUBBER CONTRACEPTIVES)

Obstetrics & Gynecology · 132d