K-number	K250034
Device name	Natural rubber latex male condom
Applicant	Shaoguan Regenex Pharmaceuticals Co., Ltd.
Product code	HIS
Device class	Class II
Decision date	Jul 11, 2025
Decision	Substantially Equivalent
Regulation	884.5300

AI Summary extracted from FDA summary PDF · never regenerated

Intended use

This is a natural rubber latex male condom classified as a Class II medical device. It is intended for contraception and prophylactic purposes to help prevent pregnancy and transmission of sexually transmitted infections.

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

Researching this as a predicate?

Want a transparent AI-ranking score, AI-discovered related predicates, ongoing safety and warning-letter monitoring, full predicate chain lineage, and a drafted SE rationale — all saved to your own project? That's what an account adds.

Start free trial →

Natural rubber latex male condom

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