GLADRAGS COTTON MENSTRUAL PAD

K980395 · Keepers!, Inc. · HHD · Apr 16, 1998 · Obstetrics/Gynecology

Device Facts

• Record ID: K980395
• Device Name: GLADRAGS COTTON MENSTRUAL PAD
• Applicant: Keepers!, Inc.
• Product Code: HHD · Obstetrics/Gynecology
• Decision Date: Apr 16, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5435
• Device Class: Class 1

Indications for Use

GladRags Cotton Menstrual Pads are washable and reusable. They are meant for personal use (use by only one person) to collect menstrual flow and are designed for external use.

Device Story

GladRags Cotton Menstrual Pads are reusable, washable external devices for menstrual flow collection. Intended for personal use by a single individual. Device functions as a physical barrier/absorbent pad worn externally to manage menstruation. No electronic, software, or complex mechanical components involved.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Cotton-based menstrual pad; washable and reusable; external form factor; non-sterile; no energy source; no software.

Indications for Use

Indicated for personal use by individuals to collect menstrual flow. Designed for external use only. Reusable and washable.

Regulatory Classification

Identification

An unscented menstrual pad is a device that is a pad made of cellulosic or synthetic material which is used to absorb menstrual or other vaginal discharge. This generic type of device includes sterile unscented menstrual pads used for medically indicated conditions, but does not include menstrual pads treated with scent (i.e., fragrance materials) or those with added antimicrobial agents or other drugs.

Submission Summary (Full Text)

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Public Health Service

APR 1 6 1998

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Brenda Mallory President Keepers! Inc. P.O. Box 12648 Portland. OR 97212 Re: K980395 GladRags Cotton Menstrual Pad Dated: January 28, 1998 Received: February 2, 1998 Regulatory Class: I 21 CFR 884.5435/Procode: 85 HHD

Dear Ms. Mallory:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its Internet address "http://www.fda.gov/cdrb/dsmaldsmamain.html".

Sincerely yours

Lillian Yin, Ph.D.

Director, Division of Reproductive, Abdominal, Ear, Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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| K | 980395 |
|---|--------|
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Keepers! Inc. PO Box 12648 Portland OR 97212 503.282.0436 FAX [phone] ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

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Device Name: GladRags Cotton Menstrual Pads

Statement of Indications for Use

GladRags Cotton Menstrual Pads are washable and reusable. They are meant for personal use (use by only one person) to collect menstrual flow and are designed for external use.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Rolar D. Ratliff

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K980395

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use X

(Optional Format 1-2-96)