510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K945145Substantially Equivalent

Ria Latex Condom, Nonoxynol-9

Mbf Personal Care Sdn. Bhd., Senai, Johor, MY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K945145 is the FDA 510(k) clearance record for RIA LATEX CONDOM, NONOXYNOL-9, a class II device, cleared for Mbf Personal Care Sdn. Bhd. on under FDA product code HIS (Condom). FDA records list 2 510(k) clearances for Mbf Personal Care Sdn. Bhd., from to . As of , FDA records show no recalls naming K945145.

Clearance record

Decision date
Received
(489 days to decision)
Product code
HIS Condom
Regulation
21 CFR 884.5300
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Mbf Personal Care Sdn. Bhd. Plo 22,Senai Industrial Estate, Senai, Johor, 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