HEB · Tampon, Menstrual, Unscented
Obstetrics/Gynecology · 21 CFR 884.5470 · Class 2
Overview
| Product Code | HEB |
|---|---|
| Device Name | Tampon, Menstrual, Unscented |
| Regulation | 21 CFR 884.5470 |
| Device Class | Class 2 |
| Review Panel | Obstetrics/Gynecology |
| 3rd-Party Reviewable | Yes |
Identification
An unscented menstrual tampon is a device that is a plug made of cellulosic or synthetic material that is inserted into the vagina and used to absorb menstrual or other vaginal discharge. This generic type of device does not include menstrual tampons treated with scent (i.e., fragrance materials) or those with added antimicrobial agents or other drugs.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 189)
Showing 20 most recent of 189 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K252005 | Livi Device | Liviwell, Inc. | Mar 20, 2026 | SESE |
| K253719 | Unscented Menstrual Long Applicator Tampon; Unscented Menstrual Cardboard Applicator Tampon; Unscented Menstrual Digital Tampons | Unibeauty (Hubei) Technology Co., Ltd. | Dec 17, 2025 | SESE |
| K252939 | COHITECH ORGANIC COTTON COMPACT APPLICATOR TAMPONS | Cotton High Tech S.L. | Oct 9, 2025 | SESE |
| K252613 | Unscented menstrual three-piece applicator tampon | Unibeauty (Hubei) Technology Co., Ltd. | Sep 19, 2025 | SESE |
| K251033 | Unscented menstrual long applicator tampon; Unscented menstrual Compact Applicator Tampon; Unscented menstrual Cardboard Applicator Tampon; Unscented menstrual Digital Tampons | Unibeauty (Hubei) Technology Co., Ltd. | Aug 13, 2025 | SESE |
| K242105 | SABA Tampons | Essity Higiene Y Salud Mexico. S.A. DE C.V. | Apr 1, 2025 | SESE |
| K241064 | Unscented Tampon | Shandong Intco Hygiene Products Co., Ltd. | Jan 10, 2025 | SESE |
| K240708 | Organic Cotton Tampon; Organic Cotton PESCVcord Tampon | Suzhou Borage Medical Technology Co., Ltd. | May 10, 2024 | SESE |
| K232060 | TOSAMA Reusable Applicator | Tosama, D.O.O. | Apr 12, 2024 | SESE |
| K232598 | Unscented Menstrual Tampon | Unibeauty (Hubei) Technology Co., Ltd. | Dec 15, 2023 | SESE |
| K223883 | Daye Tampon | Annes Daye, Ltd. | Aug 18, 2023 | SESE |
| K231341 | Organic cotton tampon, Viscose tampon | Zhejiang Tianqing Manufacturing Technology Group Co., Ltd. | Aug 14, 2023 | SESE |
| K230419 | Sequel Tampon with Plastic Applicator | Tampro, Inc. | Aug 3, 2023 | SESE |
| K223749 | U by Kotex® Click® Unscented Menstrual Tampons | Kimberly-Clark Corporation | Jan 6, 2023 | SESE |
| K222046 | Unscented Menstrual Tampon | Suzhou Borage Medical Technology Co., Ltd. | Sep 30, 2022 | SESE |
| K212277 | Tempo Tampon | Dong-A Pharmaceutical Co., Ltd. | Apr 21, 2022 | SESE |
| K220238 | Cohitech Cottonlock Tampons with Reusable Applicator | Cotton High Tech S.L. | Feb 25, 2022 | SESE |
| K211775 | Cohitech Organic Cotton Non-Applicator Cottonlock Tampons | Cotton High Tech S.L. | Oct 22, 2021 | SESE |
| K212479 | Cohitech Reusable Tampon Applicator | Cotton High Tech S.L. | Oct 8, 2021 | SESE |
| K212272 | Tempo Natural Tampon | Dong-A Pharmaceutical Co., Ltd. | Sep 17, 2021 | SESE |
Top Applicants
- Tambrands, Inc. — 34 clearances
- Personal Products Co. — 14 clearances
- Kimberly-Clark Corp. — 12 clearances
- First Quality Hygienic, Inc. — 8 clearances
- Cotton High Tech S.L. — 7 clearances
