K251033

Unscented menstrual long applicator tampon; Unscented menstrual Compact Applicator Tampon; Unscented menstrual Cardboard Applicator Tampon; Unscented menstrual Digital Tampons

510(k) number
K251033
Device name
Unscented menstrual long applicator tampon; Unscented menstrual Compact Applicator Tampon; Unscented menstrual Cardboard Applicator Tampon; Unscented menstrual Digital Tampons
Applicant
Unibeauty (Hubei) Technology Co., Ltd. CN
Product code
HEB — Tampon, Menstrual, Unscented
Decision date
2025-08-13
Date received
2025-04-03
Decision
Substantially Equivalent
Clearance type
Special
Advisory committee
Obstetrics/Gynecology
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain

Also available from FDA: K251033.pdf

Official FDA record: K251033
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.