K-number	K243967
Device name	ONE Nitrile Condom
Applicant	Global Protection Corp.
Product code	MOL
Device class	Class II
Decision date	Apr 8, 2025
Decision	Substantially Equivalent
Regulation	884.5300

AI Summary extracted from FDA summary PDF · never regenerated

Intended use

The ONE Nitrile Condom is a Class II medical device used for contraception and to help reduce the risk of pregnancy and transmission of sexually transmitted infections. It is marketed over-the-counter to consumers.

Technological characteristics

Not stated in this summary.

Test standards cited

Not stated in this summary.

Substantial equivalence argument

Not stated in this summary.

Extracted by AI from the official FDA summary PDF →

Source

View the full FDA submission: accessdata.fda.gov

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ONE Nitrile Condom

Everything you need for a 510(k) submission. Nothing you don't.