Cleared Special

Unscented menstrual three-piece applicator tampon

K252613 · Unibeauty (Hubei) Technology Co., Ltd. · Obstetrics & Gynecology

Sep 2025

Decision

31d

Days

Class 2

Risk

About This 510(k) Submission

K252613 is an FDA 510(k) clearance for the Unscented menstrual three-piece applicator tampon, 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 September 19, 2025, 31 days after receiving the submission on August 19, 2025. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.5470.

Submission Details

510(k) Number	K252613 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 19, 2025
Decision Date	September 19, 2025
Days to Decision	31 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.