Innolatex Sdn. Bhd

FDA Regulatory Profile

Innolatex Sdn. Bhd appears in FDA public data with 0 recalls, 9 510(k) clearances, 4 FDA inspections, and 1 compliance action on record. Its most recent 510(k) clearance was granted on February 21, 2006.

Summary

Total Recalls
0
510(k) Clearances
9
Inspections
4
Compliance Actions
1

Recent 510(k) Clearances

K-NumberDeviceDate
K053367MALE NATURAL RUBBER LATEX CONDOMFebruary 21, 2006
K041837INNOLATEX MALE LATEX CONDOMS COLORED AND SCENTEDSeptember 24, 2004
K012664ULTRA THICK MALE LATEX CONDOM WITH SILICONE LUBRICANTNovember 9, 2001
K01296456MM CONDOM,MALE NATURAL RUBBER LATEX CONDOMNovember 9, 2001
K012962DOTTED CONDOM, MALE NATURAL RUBBER LATEX CONDOMNovember 9, 2001
K012665ULTRA THIN MALE LATEX CONDOM WITH SILICONE LUBRICANTNovember 9, 2001
K010919MALE NATURAL RUBBER LATEX CONDOMJune 15, 2001
K010178SPERMICIDAL LUBRICATED MALE LATEX CONDOMApril 27, 2001
K002393NON-SPERMICIDAL LUBRICATED MALE LATEX CONDOMDecember 19, 2000