510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K070511Substantially Equivalent

Richter Male Latex Condom

Richter Rubber Technology Sbn Bhd, Durham NC / Abbreviated, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K070511 is the FDA 510(k) clearance record for RICHTER MALE LATEX CONDOM, a class II device, cleared for Richter Rubber Technology Sbn Bhd on under FDA product code HIS (Condom). FDA records list one 510(k) clearance for Richter Rubber Technology Sbn Bhd. As of , FDA records show no recalls naming K070511.

Clearance record

Decision date
Received
(326 days to decision)
Product code
HIS Condom
Regulation
21 CFR 884.5300
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Richter Rubber Technology Sbn Bhd P.O. Box 12139, Durham NC
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