Unscented Menstrual Pads

FDA 510(k) K823477 · Procter & Gamble Mfg. Co.

Substantially Equivalent

510(k) numberK823477

Submission

Device name
Unscented Menstrual Pads
Applicant
Procter & Gamble Mfg. Co.
Mchenry, IL, US
Received
November 23, 1982
Decision date
January 18, 1983
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
HHD – Pad, Menstrual, Unscented
Device class
Class I (low risk)
Regulation
21 CFR 884.5435
Specialty
Obstetrics/Gynecology

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.

Other 510(k)s with product code HHD

510(k)DeviceApplicantDecision
K071827Always Menstrual PadsHHD · Traditional Procter & Gamble, Inc.09/20/2007SE
K012629Always DuetsHHD · Traditional Procter & Gamble Co.10/05/2001SE
K003843Envive MiniformsHHD · Traditional Procter & Gamble Co.02/08/2001SE
K993870Unscented Interlabial Menstrual PadHHD · Traditional Procter & Gamble Co.01/18/2000SE
K980395Gladrags Cotton Menstrual PadHHD · Traditional Keepers!, Inc.04/16/1998SE
K953470Flushies Flushable/Biodegradable Menstrual Pads/Napkins (Ultra Thins)HHD · Traditional Mediquip, Inc.11/21/1995SE
K953668Unscented Ultrathin Maxi PadHHD · Traditional Paragon Trade Brands, Inc.11/01/1995SE
K953667Unscented Curved Ultrathin Maxi PadsHHD · Traditional Paragon Trade Brands, Inc.11/01/1995SE
K953633Unscented Menstrual PadHHD · Traditional Tendasoft, Inc.11/01/1995SE
K953553Unscented Menstral PadHHD · Traditional Paragon Trade Brands, Inc.10/27/1995SE

More from Paragon Trade Brands, Inc.

510(k)DeviceDecision
K873457Scented or Scented Deodorized Menstrual PadsHIL · Traditional 01/19/1988SE
K873036Attends Incontinent BriefEYQ · Traditional 01/19/1988SE
K864673Unscented Menstrual PadHHL · Traditional 01/21/1987SE
K861863Modified Protective GarmentEYQ · Traditional 08/11/1986SE
K862348Single-Use Patient UnderpadKME · Traditional 07/02/1986SE
K860598Modified Protective Garment for IncontinentsEYQ · Traditional 03/05/1986SE
K853880Attends Dispos. UnderpadKME · Traditional 10/16/1985SE
K853000Scented Always PantilinersHHL · Traditional 09/06/1985SE
K852985Unscented Always PantilinersHHD · Traditional 08/29/1985SE
K850956Always Maxipads - ScentedHHL · Traditional 05/14/1985SE

Questions and answers

When was Unscented Menstrual Pads cleared by the FDA?

Unscented Menstrual Pads (K823477) received a 510(k) decision of Substantially Equivalent on January 18, 1983, 56 days after the submission was received.

What is the product code of K823477?

The FDA product code is HHD – Pad, Menstrual, Unscented, a Class I (low risk) device regulated under 21 CFR 884.5435.