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510(k) DEN210034

ONE Male Condom by Global Protection Corp. — Product Code QRZ

DEN210034 is an FDA 510(k) premarket notification submitted by Global Protection Corp. for the device "ONE Male Condom". The FDA issued a decision of De Novo Granted on February 23, 2022. The device falls under product code QRZ (External Condom For Anal Intercourse Or Vaginal Intercourse), a Class II device regulated under 21 CFR 884.5305. Global Protection Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
DENG (De Novo Granted)
Decision Date
February 23, 2022
Date Received
August 26, 2021
Clearance Type
Direct
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
External Condom For Anal Intercourse Or Vaginal Intercourse
Device Class
Class II
Regulation Number
884.5305
Review Panel
OB
Submission Type

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) and for contraception (when used for vaginal intercourse). This classification does not include condoms intended for vaginal intercourse only.

Other clearances by Global Protection Corp.

  • K243972 — Plain Water-based Lubricant (August 8, 2025)
  • K250142 — Water-based Lubricant (August 8, 2025)
  • K243967 — ONE Nitrile Condom (April 8, 2025)
  • K240896 — ONE Nitrile Condom (August 23, 2024)
  • K223214 — Powder-Free Nitrile Examination Gloves (September 21, 2023)
  • K213087 — Natural Rubber Latex Ultrasound Transducer Probe Covers (June 7, 2022)
  • K203536 — Male Latex Condom (September 3, 2021)
  • K193578 — Non-spermicidal Lubricated Male Latex Condom (August 20, 2020)
  • K024324 — LATEX CONDOM AND LATEX CONDOM LUBRICATED WITH NONOXYNOL-9 (March 25, 2003)
  • K960552 — KNIGHT LIGHT NONLUBRICATED CONDOM (November 20, 1997)

FDA data resources