HHL · Class II — Moderate Risk (510(k) clearance required) · Obstetrics/Gynecology · 21 CFR 884.5425
Classification
FDA Product Code
HHL
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 884.5425
Review panel
OB
Medical specialty
Obstetrics/Gynecology
Submission type
4
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
Definition
Scented or scented-deodorized menstrual pads used to absorb menstrual or other vaginal discharge, including those intended as intralabial pads or reusable menstrual pads. These are made with materials that do not meet the requirements for Class 1 per 21 CFR 884.5425(b).