Always Scented Pantiliners
by Procter & Gamble Mfg. Co. 510(k)
Active
510(k) K853000
Overview
The Always Scented Pantiliners are a type of menstrual pad designed to absorb menstrual flow while providing a deodorizing scent. Classified as a scented-deodorized menstrual pad, they are intended for use during menstruation to help manage odor and maintain comfort.
These pantiliners are supplied as single-use, non-sterile medical devices and are regulated under FDA 510(k) clearance (K853000) with a classification of Class II. They are distributed in various sizes and packaging formats, as indicated by the associated FEI numbers, and are intended for over-the-counter use in obstetrics/gynecology settings. No MRI safety information or reusable specifications are noted.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK853000 | Date6 Sep 1985 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- Full name
- Scented Always Pantiliners
- 510(k) Number
- FDA Product Code
- HHL
- Device Class
- Class II
- Regulation
- 21 CFR Part 884.5425
- Advisory Committee
- Obstetrics/Gynecology
- FDA Decision
- SESE Substantially Equivalent
Other devices from Procter & Gamble Co.
Questions
Are these pantiliners intended for use in clinical settings like hospitals or primarily for over-the-counter purchase by consumers during menstruation?
These Always Scented Pantiliners are designed for over-the-counter use, as indicated by their classification under FDA 510(k) clearance (K853000) and their intended use in obstetrics/gynecology settings. While they may be used clinically, they are not restricted to hospital or medical facility settings and are primarily marketed for consumer purchase during menstruation to manage odor and absorb menstrual flow.
What sizes or models are available for the Always Scented Pantiliners, and how do they differ?
The Always Scented Pantiliners come in multiple sizes and packaging formats, as evidenced by the associated FEI numbers (e.g., 3019469637, 3006710549, etc.). These variations likely correspond to different absorbency levels or designs, such as regular, overnight, or ultra-thin options, though the exact distinctions between models are not specified in the data. The product code (HHL) suggests they fall under a broader category of menstrual pads, which typically includes different sizes for varying flow needs.
Are these pantiliners reusable, or are they meant to be used once and then discarded?
The Always Scented Pantiliners are explicitly described as single-use, non-sterile medical devices. This means they are intended for one-time use and should be discarded after use, rather than being cleaned or reused. The lack of any mention of reusable specifications or cleaning instructions further supports this.
How should these pantiliners be stored, and are there any specific conditions they require?
While the data does not specify exact storage conditions, single-use, non-sterile medical devices like these pantiliners are generally recommended to be stored in a cool, dry place, away from direct sunlight and moisture. The packaging should remain intact until use to preserve freshness and effectiveness. Always check the packaging for any manufacturer-specific storage instructions.
Can these pantiliners be used safely in environments with MRI machines, or are there any restrictions?
The data does not provide any MRI safety information for the Always Scented Pantiliners. As a general precaution, non-metallic, single-use medical devices like these are typically considered safe for use in MRI environments, but it is always best to confirm with the manufacturer or MRI facility guidelines. Since no metal components or ferromagnetic materials are mentioned, they are unlikely to interfere with MRI procedures.