510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K070830Substantially Equivalent

Male Natural Rubber Latex Condom (with Coloring and Flavoring)

Karex Industries Sdn Bhd, Pontian Kecil, Jalan Johor, MY / Abbreviated, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K070830 is the FDA 510(k) clearance record for MALE NATURAL RUBBER LATEX CONDOM (WITH COLORING AND FLAVORING), a class II device, cleared for Karex Industries Sdn. Bhd. on under FDA product code HIS (Condom). FDA records list 8 510(k) clearances for Karex Industries Sdn. Bhd., from to . As of , FDA records show no recalls naming K070830.

Clearance record

Decision date
Received
(43 days to decision)
Product code
HIS Condom
Regulation
21 CFR 884.5300
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Karex Industries Sdn. Bhd. Ptd. 7906/7907, Taman Pontian, Pontian Kecil, Jalan Johor, MY
510(k) summary
Summary PDF
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