Playtex Flushable Tampons Regular, Super, Super +
by Playtex Family Products, Inc.
510(k) K924279
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK924279 | Date21 May 1993 | StatusActive |
Recalls
No FDA recalls found in the data synced 5 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- HIL
- Device Class
- Class II
- Regulation
- 21 CFR Part 884.5460
- Advisory Committee
- Obstetrics/Gynecology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Playtex Flushable Tampons Regular, Super, and Super + are classified as menstrual tampons, designed for internal menstrual absorption. These disposable, single-use devices are inserted into the vagina to absorb menstrual flow, providing protection during menstruation. The product line includes varying absorbency levels to accommodate different flow intensities, ensuring comfort and reliability for users.
These tampons are supplied in sterile packaging for single-use and are intended for home use. They are classified as Class II medical devices under FDA regulations and have received 510(k) clearance through the Obstetrics/Gynecology advisory committee. The devices are not intended for MRI use and must be disposed of properly after use, as they are not designed for flushing. Each tampon is individually packaged for hygiene and convenience.
Other devices from Playtex Family Products, Inc.
Questions
AI-generated answers, 1 Oct 2026
What are Playtex Flushable Tampons Regular, Super, and Super+ used for?
These tampons are designed for internal menstrual absorption during menstruation. They are inserted into the vagina to absorb menstrual flow, providing protection and comfort for users with different flow intensities. The varying absorbency levels (Regular, Super, Super+) cater to light, moderate, and heavy menstrual flow, ensuring reliable protection throughout the menstrual cycle.
Are Playtex Flushable Tampons supplied sterile and for single-use only?
Yes, these tampons are supplied in sterile packaging, ensuring hygiene and safety for single-use only. Each tampon is individually wrapped to maintain sterility and prevent contamination before use. This design aligns with medical-grade standards for menstrual hygiene products.
Can Playtex Flushable Tampons be reused or flushed?
No, these tampons are intended for single-use only and must not be reused or flushed down toilets. They are not designed for flushing and improper disposal can cause plumbing issues. After use, they should be disposed of in a sealed trash receptacle following local waste disposal guidelines.
What absorbency levels are available, and how do they differ?
Playtex Flushable Tampons come in three absorbency levels: Regular (for light flow), Super (for moderate flow), and Super+ (for heavy flow). The absorbency levels are determined by the material and construction of the tampon, allowing users to select the appropriate size based on their menstrual flow intensity for optimal comfort and protection.
Are these tampons suitable for MRI use?
No, these tampons are not intended for use during MRI scans. The materials used in their construction may interfere with MRI imaging or pose a risk to the user. If an MRI is required, users should remove the tampon beforehand and consult their healthcare provider for guidance on alternative protection methods.