Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Unscented Menstrual Long Applicator Tampon; Unscented Menstrual Cardboard Applicator Tampon; Unscented Menstrual Digital Tampons

K-Number: K253719 · 2025-12-17

ApplicantUnibeauty (Hubei) Technology Co., Ltd.
Decision Date2025-12-17
Product CodeHEB
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Unscented Menstrual Long Applicator Tampon; Unscented Menstrual Cardboard Applicator Tampon; Unscented Menstrual Digital Tampons is a medical device manufactured by Unibeauty (Hubei) Technology Co., Ltd.. It received FDA 510(k) clearance on 2025-12-17 under approval number K253719. The device is classified under product code HEB. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Unscented Menstrual Long Applicator Tampon; Unscented Menstrual Cardboard Applicator Tampon; Unscented Menstrual Digital Tampons?

Unscented Menstrual Long Applicator Tampon; Unscented Menstrual Cardboard Applicator Tampon; Unscented Menstrual Digital Tampons is a medical device that received FDA 510(k) clearance on 2025-12-17. It is manufactured by Unibeauty (Hubei) Technology Co., Ltd.. The 510(k) number is K253719.

When was Unscented Menstrual Long Applicator Tampon; Unscented Menstrual Cardboard Applicator Tampon; Unscented Menstrual Digital Tampons approved by the FDA?

Unscented Menstrual Long Applicator Tampon; Unscented Menstrual Cardboard Applicator Tampon; Unscented Menstrual Digital Tampons received FDA 510(k) clearance on 2025-12-17, under approval number K253719.

What company makes Unscented Menstrual Long Applicator Tampon; Unscented Menstrual Cardboard Applicator Tampon; Unscented Menstrual Digital Tampons?

Unscented Menstrual Long Applicator Tampon; Unscented Menstrual Cardboard Applicator Tampon; Unscented Menstrual Digital Tampons is manufactured by Unibeauty (Hubei) Technology Co., Ltd..

What is the FDA product code for Unscented Menstrual Long Applicator Tampon; Unscented Menstrual Cardboard Applicator Tampon; Unscented Menstrual Digital Tampons?

The FDA product code for Unscented Menstrual Long Applicator Tampon; Unscented Menstrual Cardboard Applicator Tampon; Unscented Menstrual Digital Tampons is HEB.

Related Clinical Trials

NCT07561905 Tampon Safety-in-Use Study RECRUITING

Other Devices by Unibeauty (Hubei) Technology Co., Ltd.

K232598Unscented Menstrual Tampon K252613Unscented menstrual three-piece applicator tampon K251033Unscented menstrual long applicator tampon; Unscented menstrual Compact Applicator Tampon; Unscented menstrual Cardboard Applicator Tampon; Unscented menstrual Digital Tampons

Related Devices (Code: HEB)

K161877Opal by Femtex Pull & Snap and Private Label Unscented Compact Applicator Tampon, RegularOpal by Femtex Pull & Snap and Private Label Unscented Compact Applicator Tampon, Super, Opal by Femtex Pull & Snap and Private Label Unscented Compact Applicator Tampon, Super PlFirst Quality Hygienic, Inc. K172118U by Kotex Click Unscented Menstrual TamponsKimberly-Clark Corporation K162746Ontex and other proprietary namesOntex Bvba K181911Interlude 100% Cotton TamponAlbaad Fem K180850re.t.a Reuseable Tampon ApplicatorThinx, Inc. K173225Interlude and private label Unscented 3-piece compact applicator tamponAlbaad Fem

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑