K-number	K252935
Device name	Hybrid personal lubricant (water&silicone) (5ml, 8ml, 10ml, 12ml, 15ml, 20ml, 30ml, 50ml, 60ml, 75ml, 90ml, 100ml, 120ml, 150ml, 180ml, 200ml, 250ml, 300ml, 500ml)
Applicant	Foshan Pingchuang Medical Technology Co., Ltd.
Product code	NUC
Device class	Class II
Decision date	Dec 15, 2025
Decision	Substantially Equivalent
Regulation	884.5300

AI Summary extracted from FDA summary PDF · never regenerated

Intended use

This is a hybrid personal lubricant containing both water and silicone in multiple bottle sizes (5ml to 500ml). It is intended for penile, anal, and/or vaginal application to moisturize, lubricate, and enhance comfort during intimate sexual activity while supplementing natural lubrication. The product 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.

Extracted by AI from the official FDA summary PDF →

Source

View the full FDA submission: accessdata.fda.gov

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Hybrid personal lubricant (water&silicone) (5ml, 8ml, 10ml, 12ml, 15ml, 20ml, 30ml, 50ml, 60ml, 75ml, 90ml, 100ml, 120ml, 150ml, 180ml, 200ml, 250ml, 300ml, 500ml)

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