ALATECH LATEX CONDOM

K993887 · Alatech Healthcare, LLC · HIS · Dec 20, 1999 · Obstetrics/Gynecology

Device Facts

• Record ID: K993887
• Device Name: ALATECH LATEX CONDOM
• Applicant: Alatech Healthcare, LLC
• Product Code: HIS · Obstetrics/Gynecology
• Decision Date: Dec 20, 1999
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 884.5300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Alatech Condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases).

Device Story

The Alatech Lubricated Male Latex Condom is a barrier device designed for contraception and the prevention of sexually transmitted diseases. It is intended for over-the-counter use by individuals. The device functions as a physical barrier to prevent the exchange of bodily fluids during sexual intercourse. It is a single-use, disposable product.

Clinical Evidence

No clinical data provided; substantial equivalence is based on established device classification and intended use.

Technological Characteristics

Material: Natural latex rubber. Form factor: Male condom. Lubricated. Single-use. Non-sterile (implied by standard condom manufacturing).

Indications for Use

Indicated for contraception and prevention of pregnancy and sexually transmitted diseases in individuals seeking barrier protection.

Regulatory Classification

Identification

A condom is a sheath which completely covers the penis with a closely fitting membrane. The condom is used for contraceptive and for prophylactic purposes (preventing transmission of sexually transmitted infections). The device may also be used to collect semen to aid in the diagnosis of infertility.

Special Controls

*Classification.* (1) Class II (special controls) for condoms made of materials other than natural rubber latex, including natural membrane (skin) or synthetic.(2) Class II (special controls) for natural rubber latex condoms. The guidance document entitled “Class II Special Controls Guidance Document: Labeling for Natural Rubber Latex Condoms Classified Under 21 CFR 884.5300” will serve as the special control. See § 884.1(e) for the availability of this guidance document.

Submission Summary (Full Text)

{0}------------------------------------------------

Public Health Service

Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN" around the top half and ".USA" on the right side. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, represented by three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

GEC 2 0 1999

Mr. Wayne L. Gainey Vice President of Operations ALATECH, LLC 595 East Lawrence Harris Hwy. Slocomb, AL 36375

Re: K993887 ALATECH Lubricated Male Latex Condom Dated: November 15, 1999 Received: November 16, 1999 Regulatory Class: II 21 CFR 884.5300/Procode: 85 HIS

Dear Mr. Gainey:

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 legally marketed predicate 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 requlations 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 (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS 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 531 through 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 requlation 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/cdrh/dsma/dsmamain.html".

Sincerely yours,

CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{1}------------------------------------------------

## K993887

## VII. INDICATIONS FOR USE STATEMENT

510(K) Number: _ N/A

OR

Alatech Male Natural Latex Condom Device Name:

The Alatech Condom is used for contraception and for Indication for Use: prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases).

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Over-The -Counter Use

(vision Sign-Off)

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 93887 510(k) Number.