510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN210034Unknown

ONE Male Condom

Global Protection Corp., Boston MA / Direct, Unknown
FDA source (opens on fda.gov)

DEN210034 is the FDA 510(k) clearance record for ONE Male Condom, a class II device, cleared for Global Protection Corp. on under FDA product code QRZ (External Condom For Anal Intercourse Or Vaginal Intercourse). FDA's definition for product code QRZ reads: "An external condom for anal intercourse or vaginal intercourse is a barrier device which covers the penis and is used to prevent the transmission of sexually transmitted infections (when used for anal intercourse or vaginal intercourse)...". FDA records list 11 510(k) clearances for Global Protection Corp., from to . As of , FDA records show no recalls naming DEN210034.

Clearance record

Decision date
Received
(181 days to decision)
Product code
QRZ External Condom For Anal Intercourse Or Vaginal Intercourse
Regulation
21 CFR 884.5305
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Global Protection Corp. 12 Channel St., Boston MA
Third party review
No

Clearances, product code QRZ

Trailing 12 months

FDA records hold no clearances under product code QRZ in the trailing twelve months.

FDA records show no clearances under product code QRZ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code QRZ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260