510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K243967Substantially Equivalent

ONE Nitrile Condom

Global Protection Corp., Boston MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K243967 is the FDA 510(k) clearance record for ONE Nitrile Condom, a class II device, cleared for Global Protection Corp. on under FDA product code MOL (Condom, Synthetic). FDA records list 11 510(k) clearances for Global Protection Corp., from to . As of , FDA records show no recalls naming K243967.

Clearance record

Decision date
Received
(106 days to decision)
Product code
MOL Condom, Synthetic
Regulation
21 CFR 884.5300
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Global Protection Corp. 12 Channel St., Boston MA
510(k) summary
Statement
Third party review
No

Clearances, product code MOL

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