Cleared Special

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

K251033 · Unibeauty (Hubei) Technology Co., Ltd. · Obstetrics & Gynecology

Aug 2025

Decision

132d

Days

Class 2

Risk

About This 510(k) Submission

K251033 is an FDA 510(k) clearance for the Unscented menstrual long applicator tampon; Unscented menstrual Compact Applicator Tampon; Unscented menstrual Cardboard Applicator Tampon; Unscented menstrual Digital Tampons, a Tampon, Menstrual, Unscented (Class II — Special Controls, product code HEB), submitted by Unibeauty (Hubei) Technology Co., Ltd. (Xiantao, CN). The FDA issued a Cleared decision on August 13, 2025, 132 days after receiving the submission on April 3, 2025. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.5470.

Submission Details

510(k) Number	K251033 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 03, 2025
Decision Date	August 13, 2025
Days to Decision	132 days
Submission Type	Special
Review Panel	Obstetrics & Gynecology (OB)
Summary	Summary PDF

Device Classification

Product Code	HEB — Tampon, Menstrual, Unscented
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 884.5470
Definition	An Unscented Menstrual Tampon Is A Plug Made Of Cellulosic Or Synthetic Material That Is Inserted Into The Vagina And Used To Absorb Menstrual Fluid Or Other Vaginal Discharge.