K252935

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

510(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. CN
Product code: NUC — Lubricant, Personal
Decision date: 2025-12-15
Date received: 2025-09-15
Decision: Substantially Equivalent
Clearance type: Traditional
Advisory committee: Obstetrics/Gynecology

This submission filed a 510(k) Statement rather than a Summary; no public summary is available from FDA.

Official FDA record: K252935

Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.