Medical Device Manufacturer · MY , Shah Alam,Selangor Darul Ehsan

Innolatex Sdn. Bhd - FDA 510(k) Cleared Devices

9 submissions · 9 cleared · Since 2000

Recent clearances: MALE NATURAL RUBBER LATEX CONDOM, INNOLATEX MALE LATEX CONDOMS COLORED AND SCENTED, ULTRA THICK MALE LATEX CONDOM WITH SILICONE LUBRICANT

View 9 510(k) Devices ↓
9
Total
9
Cleared
0
Denied

FDA 510(k) Regulatory Record - Innolatex Sdn. Bhd Obstetrics & Gynecology ✕

9 devices
1-9 of 9
Cleared Feb 21, 2006
MALE NATURAL RUBBER LATEX CONDOM
K053367 · HIS
Obstetrics & Gynecology · 78d
Cleared Sep 24, 2004
INNOLATEX MALE LATEX CONDOMS COLORED AND SCENTED
K041837 · HIS
Obstetrics & Gynecology · 79d
Cleared Nov 09, 2001
ULTRA THICK MALE LATEX CONDOM WITH SILICONE LUBRICANT
K012664 · HIS
Obstetrics & Gynecology · 88d
Cleared Nov 09, 2001
ULTRA THIN MALE LATEX CONDOM WITH SILICONE LUBRICANT
K012665 · HIS
Obstetrics & Gynecology · 88d
Cleared Nov 09, 2001
DOTTED CONDOM, MALE NATURAL RUBBER LATEX CONDOM
K012962 · HIS
Obstetrics & Gynecology · 66d
Cleared Nov 09, 2001
56MM CONDOM,MALE NATURAL RUBBER LATEX CONDOM
K012964 · HIS
Obstetrics & Gynecology · 66d
Cleared Jun 15, 2001
MALE NATURAL RUBBER LATEX CONDOM
K010919 · HIS
Obstetrics & Gynecology · 80d
Cleared Apr 27, 2001
SPERMICIDAL LUBRICATED MALE LATEX CONDOM
K010178 · LTZ
Obstetrics & Gynecology · 98d
Cleared Dec 19, 2000
NON-SPERMICIDAL LUBRICATED MALE LATEX CONDOM
K002393 · HIS
Obstetrics & Gynecology · 134d
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