Scented or Scented Deodorized Menstrual Pads
510(k) K880734
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK880734 | Date25 Apr 1988 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- HHI
- Device Class
- Class II
- Regulation
- 21 CFR Part 884.5070
- Advisory Committee
- Obstetrics/Gynecology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
This device is a scented or scented-deodorized menstrual pad, classified under 21 CFR 884.5425 as a disposable absorbent product designed to manage menstrual or vaginal discharge. Constructed from cellulosic or synthetic materials, it incorporates fragrance to neutralize odors while providing absorption and comfort during menstruation.
Intended for single-use, these pads are supplied in sterile or non-sterile packaging depending on the manufacturer’s specifications. They are regulated under 21 CFR 884.5070 and have received FDA 510(k) clearance as substantially equivalent to predicate devices. No MRI safety considerations apply, and sizes vary by brand and design. Storage should follow manufacturer instructions to maintain integrity.
Other devices from Personal Products Co.
Questions
AI-generated answers, 19 Sep 2026
Are these menstrual pads designed for reuse or are they intended for single-use only?
These scented or scented-deodorized menstrual pads are explicitly designed for single-use only, as stated in the device description. The manufacturer’s specifications indicate they are not intended to be reused, aligning with typical disposable absorbent product standards.
Do these pads come in sterile packaging, or should I expect non-sterile options?
The packaging for these pads can vary—some may be supplied in sterile packaging, while others may be non-sterile, depending on the manufacturer’s specifications. Always check the product labeling or manufacturer instructions to confirm sterility before use.
What sizes are available for these scented menstrual pads, and how do I know which one to choose?
The available sizes for these pads vary by brand and design, but no specific measurements are provided in the data. Typically, menstrual pads come in standard sizes like regular, overnight, or lightweight. To determine the right fit, refer to the manufacturer’s sizing guide or product packaging, as individual comfort and flow needs differ.
How should I store these pads to keep them in good condition before use?
Storage instructions are not detailed in the provided data, but the general recommendation for disposable menstrual pads is to keep them in a cool, dry place, away from direct sunlight or moisture. Always follow the manufacturer’s specific storage guidelines to maintain the pad’s integrity and effectiveness.
What regulatory pathway did these pads follow to gain market authorization, and which committee reviewed them?
These scented or scented-deodorized menstrual pads received FDA 510(k) clearance under the traditional review pathway, determined to be substantially equivalent to predicate devices. The review was conducted by the Obstetrics/Gynecology (OB) Advisory Committee, as noted in the advisory committee description and registration details.