DeviceClearance

Product code HHL— Obstetrics/Gynecology

SCENTED MENSTRUAL PADS

Classification name
Pad, Menstrual, Scented, Scented-Deodorized
Device class
Class 2
Regulation
21 CFR 884.5425
Advisory panel
Obstetrics/Gynecology
Total cleared
57
First cleared
Most recent

FDA classification 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).”

— U.S. Food and Drug Administration, device classification record for product code HHL under 21 CFR 884.5425, via openFDA

Market context for product code HHL

FDA has cleared 57 devices under product code HHL between 1976 and 1996, filed by 16 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

last 15 years

Top applicants under product code HHL

Recent clearances under product code HHL

Data sourced from openFDA. This site is unofficial and independent of the FDA.