K-number	K243972
Device name	Plain Water-based Lubricant
Applicant	Global Protection Corp.
Product code	NUC
Device class	Class II
Decision date	Aug 8, 2025
Decision	Substantially Equivalent
Regulation	884.5300

AI Summary extracted from FDA summary PDF · never regenerated

Intended use

Plain water-based lubricant is a water-based product intended for penile, vaginal, and/or anal application to moisturize, lubricate, and enhance comfort during intimate sexual activity. It supplements the body's natural lubrication and is compatible with natural rubber latex and polyisoprene condoms, but not polyurethane condoms.

Technological characteristics

Not stated in this summary.

Test standards cited

Not stated in this summary.

Substantial equivalence argument

Not stated in this summary. The document confirms substantial equivalence was determined for the indications for use but does not disclose the predicate device, comparative testing data, or the specific reasoning used to establish equivalence.

Extracted by AI from the official FDA summary PDF →

Source

View the full FDA submission: accessdata.fda.gov

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Plain Water-based Lubricant

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