O.B. Tampon
FDA 510(k) K990536 · Personal Products Co.
510(k) numberK990536
Submission
- Device name
- O.B. Tampon
- Applicant
- Personal Products Co.
Skillman, NJ, US - Received
- February 19, 1999
- Decision date
- August 31, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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.
Other 510(k)s with product code HEB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252005 | Livi DeviceHEB · Traditional | Liviwell, Inc. | 03/20/2026SE |
| K253719 | Unscented Menstrual Long Applicator Tampon; Unscented Menstrual Cardboard Applicator…HEB · Special | Unibeauty (Hubei) Technology Co., Ltd. | 12/17/2025SE |
| K252939 | Cohitech Organic Cotton Compact Applicator TamponsHEB · Special | Cotton High Tech S.L. | 10/09/2025SE |
| K252613 | Unscented menstrual three-piece applicator tamponHEB · Special | Unibeauty (Hubei) Technology Co., Ltd. | 09/19/2025SE |
| K251033 | Unscented menstrual long applicator tampon; Unscented menstrual Compact Applicator…HEB · Special | Unibeauty (Hubei) Technology Co., Ltd. | 08/13/2025SE |
| K242105 | SABA TamponsHEB · Traditional | Essity Higiene Y Salud Mexico. S.A. DE C.V. | 04/01/2025SE |
| K241064 | Unscented TamponHEB · Traditional | Shandong Intco Hygiene Products Co., Ltd. | 01/10/2025SE |
| K240708 | Organic Cotton Tampon; Organic Cotton PESCVcord TamponHEB · Traditional | Suzhou Borage Medical Technology Co., Ltd. | 05/10/2024SE |
| K232060 | TOSAMA Reusable ApplicatorHEB · Traditional | Tosama, D.O.O. | 04/12/2024SE |
| K232598 | Unscented Menstrual TamponHEB · Traditional | Unibeauty (Hubei) Technology Co., Ltd. | 12/15/2023SE |
More from Unibeauty (Hubei) Technology Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K070545 | K-Y Brand Warming LiquidNUC · Special | 03/23/2007SE |
| K062796 | K-Y Brand IntrigueNUC · Traditional | 12/08/2006SE |
| K010365 | Ortho Control Female Urinary Control DeviceMNG · Traditional | 04/30/2001SE |
| K991118 | O.B. Applicator Tampons, O.B. TamponsHEB · Traditional | 06/29/1999SE |
| K974629 | O.B. Applicator and Non-Applicator TamponsHEB · Traditional | 02/10/1998SE |
| K971589 | Reach Antibacterial ToothbrushEFW · Traditional | 07/24/1997SE |
| K970954 | O.B. Applicator TamponsHEB · Traditional | 06/10/1997SE |
| K961119 | Carefree PantylinersHHL · Traditional | 04/17/1996SE |
| K953638 | O.B. Applicator TamponsHIL · Traditional | 10/20/1995SE |
| K941863 | O.B. TamponHEB · Traditional | 06/27/1994SE |
Questions and answers
When was O.B. Tampon cleared by the FDA?
O.B. Tampon (K990536) received a 510(k) decision of Substantially Equivalent on August 31, 1999, 193 days after the submission was received.
What is the product code of K990536?
The FDA product code is HEB – Tampon, Menstrual, Unscented, a Class II (moderate risk) device regulated under 21 CFR 884.5470.