Pad, Menstrual, Reusable
The Reusable Menstrual Pad is a washable absorbent product made of cellulosic or synthetic material used to absorb menstrual fluid or other vaginal discharge, designed for multiple uses following laundering. It is an FDA Class 1 device regulated under 21 CFR 884.5435 in the Obstetrics/Gynecology specialty, with product code NUQ, and is exempt from premarket notification under submission type 4. It does not carry implant or life-sustaining support designations.
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Basic Information
- Product Code
- NUQ
- Device Class
- FDA class 1
- Regulation Number
- 884.5435
- Medical Specialty
- Obstetrics/Gynecology
- Review Panel
- OB
- Submission Type
- 4
Device Characteristics
Definition
A reusable, unscented menstrual pad which is used to absorb menstrual fluid or other vaginal discharge and is made of common cellulosic or synthetic material with an established safety profile.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K010986 | LUNAPADS | Jun 13, 2001 | Substantially Equivalent | Lunapads International Products, Ltd. |
FEI Numbers
This FDA classification entry is associated with 81 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 81 registration numbers. Click on an entry to view related FDA registrations.