Whenever(R) Unscented Super Maxi Pad

FDA 510(k) K901690 · Marcal Paper Mills, Inc.

Substantially Equivalent

510(k) numberK901690

Submission

Device name
Whenever(R) Unscented Super Maxi Pad
Applicant
Marcal Paper Mills, Inc.
Elmwood Park, NJ, US
Received
April 10, 1990
Decision date
August 21, 1990
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
K861357Whenever Unscented Panty ShieldHHD · Traditional 04/23/1986SE
K861356Whenever Unscented Super Thin Maxi-PadsHHD · Traditional 04/23/1986SE
K861355Whenever Unscented Regular Thin Maxi-PadsHHD · Traditional 04/23/1986SE

Questions and answers

When was Whenever(R) Unscented Super Maxi Pad cleared by the FDA?

Whenever(R) Unscented Super Maxi Pad (K901690) received a 510(k) decision of Substantially Equivalent on August 21, 1990, 133 days after the submission was received.

What is the product code of K901690?

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