K-number	K241617
Device name	Durex Polyisoprene Condom
Applicant	Rb Health (Us), LLC
Product code	MOL
Device class	Class II
Decision date	Feb 28, 2025
Decision	Substantially Equivalent
Regulation	884.5300

AI Summary extracted from FDA summary PDF · never regenerated

Intended use

The Durex Polyisoprene Condom is a contraceptive device used to help reduce the risk of pregnancy and transmission of sexually transmitted infections (STIs). It is marketed for over-the-counter use.

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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Durex Polyisoprene Condom

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