Product Code: NRC FDA class 1 21 CFR 884.5425

Pad, Menstrual, Scented, Scented-Deodorized Made Of Common Cellulosic & Synthetic Material W/Established Safety Profile

Obstetrics/Gynecology

Scented or scented-deodorized menstrual pads are absorbent products made of common cellulosic or synthetic materials used to absorb menstrual or other vaginal discharge. These pads do not include products treated with antimicrobial agents. They are FDA Class 1 devices, meaning they are subject to general controls only and are exempt from premarket notification, regulated under 21 CFR 884.5425 in the Obstetrics/Gynecology specialty with product code NRC. These devices have an established safety profile and represent a low-risk category of personal care items. No implant or life-sustaining support flags apply.

510(k)s
0
FEI Numbers
84
Registration Numbers
85
Unique Applicants
0
Years Active

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Basic Information

Product Code
NRC
Device Class
FDA class 1
Regulation Number
884.5425
Medical Specialty
Obstetrics/Gynecology
Review Panel
OB
Submission Type
4

Device Characteristics

GMP Exempt
Implant
Life Sustain/Support
Third Party
Summary Malfunction Reporting

Definition

Scented or scented-deodorized menstrual pads used to absorb menstrual or other vaginal discharge, not intended as intralabial pads or reusable menstrual pads. These are made of common cellulosic or synthetic material with an established safety profile.

FEI Numbers

This FDA classification entry is associated with 84 FEI numbers. Click on an entry to view related FDA registrations.

Registration Numbers

This FDA classification entry is associated with 85 registration numbers. Click on an entry to view related FDA registrations.