Interlude and private label Unscented 3-piece compact applicator tampon

FDA 510(k) K173225 · Albaad Fem

Substantially Equivalent

510(k) numberK173225

Submission

Device name
Interlude and private label Unscented 3-piece compact applicator tampon
Applicant
Albaad Fem
Caesarea Ind. Park, IL
Received
October 3, 2017
Decision date
June 15, 2018
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
HEB – Tampon, Menstrual, Unscented
Device class
Class II (moderate risk)
Regulation
21 CFR 884.5470
Specialty
Obstetrics/Gynecology

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.

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K242105SABA TamponsHEB · Traditional Essity Higiene Y Salud Mexico. S.A. DE C.V.04/01/2025SE
K241064Unscented TamponHEB · Traditional Shandong Intco Hygiene Products Co., Ltd.01/10/2025SE
K240708Organic Cotton Tampon; Organic Cotton PESCVcord TamponHEB · Traditional Suzhou Borage Medical Technology Co., Ltd.05/10/2024SE
K232060TOSAMA Reusable ApplicatorHEB · Traditional Tosama, D.O.O.04/12/2024SE
K232598Unscented Menstrual TamponHEB · Traditional Unibeauty (Hubei) Technology Co., Ltd.12/15/2023SE

More from Unibeauty (Hubei) Technology Co., Ltd.

510(k)DeviceDecision
K191431Interlude Rolled Tampons in Plastic ApplicatorHEB · Traditional 10/07/2019SE
K181911Interlude 100% Cotton TamponHEB · Traditional 11/02/2018SE

Questions and answers

When was Interlude and private label Unscented 3-piece compact applicator tampon cleared by the FDA?

Interlude and private label Unscented 3-piece compact applicator tampon (K173225) received a 510(k) decision of Substantially Equivalent on June 15, 2018, 255 days after the submission was received.

What is the product code of K173225?

The FDA product code is HEB – Tampon, Menstrual, Unscented, a Class II (moderate risk) device regulated under 21 CFR 884.5470.