HHD — Pad, Menstrual, Unscented Class I

FDA Device Classification

FDA product code HHD covers "Pad, Menstrual, Unscented", a Class I medical device regulated under 21 CFR 884.5435. Submissions are reviewed by the Obstetrics/Gynecology panel. At least 20 recent 510(k) clearances have been granted under this product code.

Classification details

Product Code
HHD
Device Class
Class I
Regulation Number
884.5435
Submission Type
510(k) Exempt
Review Panel
OB
Medical Specialty
Obstetrics/Gynecology
Implant
No

Definition

An unscented menstrual pad which is used to absorb menstrual fluid or other vaginal discharge and is made of common cellulosic and synthetic material with an established safety profile.

Recent 510(k) clearances

K-NumberApplicantDevice NameDate
K071827Procter And GambleALWAYS MENSTRUAL PADSSep 20, 2007
K012629Procter And GambleALWAYS DUETSOct 5, 2001
K003843Procter And GambleENVIVE MINIFORMSFeb 8, 2001
K993870Procter And GambleUNSCENTED INTERLABIAL MENSTRUAL PADJan 18, 2000
K980395Keepers!GLADRAGS COTTON MENSTRUAL PADApr 16, 1998
K953470MediquipFLUSHIES FLUSHABLE/BIODEGRADABLE MENSTRUAL PADS/NAPKINS (ULTRA THINS)Nov 21, 1995
K953668Paragon Trade BrandsUNSCENTED ULTRATHIN MAXI PADNov 1, 1995
K953633TendasoftUNSCENTED MENSTRUAL PADNov 1, 1995
K953667Paragon Trade BrandsUNSCENTED CURVED ULTRATHIN MAXI PADSNov 1, 1995
K953553Paragon Trade BrandsUNSCENTED MENSTRAL PADOct 27, 1995
K953517Paragon Trade BrandsUNSCENTED MENSTRUAL PADOct 26, 1995
K953700Paragon Trade BrandsUNSCENTED CURVED MAXI PADSep 27, 1995
K953666Paragon Trade BrandsUNSCENTED MENSTRAL PAD WITH WINGSSep 27, 1995
K953488Paragon Trade BrandsUNSCENTED MENSTRUAL LINERAug 9, 1995
K953487Paragon Trade BrandsUNSCENTED MENSTRUAL SHIELDAug 9, 1995
K951693Sterling U.S.ACARESS SANITARY NAPKINJul 25, 1995
K924502Keema AndREUSABLE MENSTRUAL PADNov 30, 1994
K942814Kegan And KeganSELF SUPER MAXI SNAITARY NAPKINSAug 5, 1994
K940468B.A. WholesaleFEMININE MAXI PADSMay 26, 1994
K922911Feminine OptionsOPTIONS COMFORT CURVES CLOTH MENSTRUAL PAD SYSTEMApr 22, 1994

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.