← Back to catalogue

Non-spermicidal Lubricated Male Latex Condom

FDA 510(k)

Class II (US FDA 510(k))

510(k) K193578

by Global Protection Corp.

Identifiers

510(k) Number
K193578 FDA 510(k)
FDA Product Code
HIS FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 884.5300 FDA 510(k)
Regulation Number
884.5300 FDA 510(k)
Advisory Committee
Obstetrics/Gynecology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

A non-spermicidal lubricated male latex condom is a physical barrier device intended for over-the-counter use to prevent pregnancy and sexually transmitted infections, including HIV/AIDS. It functions as a mechanical barrier during sexual intercourse and contains no electronic, software, or algorithmic components.

The device is supplied as a single-use product and is classified as a Class II medical device under product code HIS. It received FDA 510(k) clearance (K193578) on August 20, 2020, following submission by Global Protection Corp. in Boston, Massachusetts. The clearance was granted under regulation number 884.5300 with an abbreviated review process.

Frequently asked questions

What is the intended use of this non-spermicidal lubricated male latex condom?

It is intended as a physical barrier device for over-the-counter use to prevent pregnancy and sexually transmitted infections, including HIV/AIDS, by functioning as a mechanical barrier during sexual intercourse.

Is this condom designed for single-use or reuse?

The device is supplied as a single-use product, meaning it is intended for one-time use only and should not be reused to ensure effectiveness and safety.

What regulatory pathway was used for this condom's clearance?

It received FDA 510(k) clearance (K193578) on August 20, 2020, following submission by Global Protection Corp., and was granted under regulation number 884.5300 with an abbreviated review process.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Non-spermicidal Lubricated Male Latex Condom (K193578 ... - fda ..., Non-spermicidal Lubricated Male Latex Condom — FDA K193578, K193578 - Non-spermicidal Lubricated Male Latex C...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Global Protection Corp.

Sources (1)

  • FDA 510(k) K193578 24 fields · synced Sep 25, 2026