510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K012665Substantially Equivalent

Ultra Thin Male Latex Condom with Silicone Lubricant

Innolatex Sdn. Bhd, Shah Alam,Selangor Darul Ehsan, MY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K012665 is the FDA 510(k) clearance record for ULTRA THIN MALE LATEX CONDOM WITH SILICONE LUBRICANT, a class II device, cleared for Innolatex Sdn. Bhd on under FDA product code HIS (Condom). FDA records list 9 510(k) clearances for Innolatex Sdn. Bhd, from to . As of , FDA records show no recalls naming K012665.

Clearance record

Decision date
Received
(88 days to decision)
Product code
HIS Condom
Regulation
21 CFR 884.5300
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Innolatex Sdn. Bhd No 16, Jalan Bulan U5/5, Shah Alam,Selangor Darul Ehsan, MY
510(k) summary
Statement
Third party review
No

Clearances, product code HIS

Trailing 12 months
3 clearances under product code HIS in the twelve months to October 2026, November 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code HIS, trailing twelve months
MonthClearances
November 20251
December 20250
January 20260
February 20260
March 20260
April 20260
May 20261
June 20260
July 20260
August 20260
September 20261
October 20260