ULTRA THIN MALE LATEX CONDOM WITH SILICONE LUBRICANT

K012665 · Innolatex Sdn. Bhd · HIS · Nov 9, 2001 · Obstetrics/Gynecology

Device Facts

• Record ID: K012665
• Device Name: ULTRA THIN MALE LATEX CONDOM WITH SILICONE LUBRICANT
• Applicant: Innolatex Sdn. Bhd
• Product Code: HIS · Obstetrics/Gynecology
• Decision Date: Nov 9, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5300
• Device Class: Class 2

Intended Use

The [No particular brand name] condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases).

Device Story

The device is a natural rubber latex condom with silicone lubricant. It acts as a physical barrier to prevent pregnancy and the transmission of sexually transmitted diseases. It is intended for over-the-counter use by individuals. The device functions as a mechanical barrier; no electronic, software, or algorithmic components are involved.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on the established nature of the device type and compliance with regulatory requirements for latex condoms, including expiration dating and labeling standards.

Technological Characteristics

Natural rubber latex condom with silicone lubricant. Physical barrier device. No electronic components, software, or energy sources. Complies with 21 CFR 884.5300 and 21 CFR 801.435 labeling and expiration dating requirements.

Indications for Use

Indicated for use by males for contraception and to help prevent pregnancy and the transmission of sexually transmitted diseases.

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)

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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined snakes and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 0 9 2001

Mr. Chang Ah-Kau Managing Director INNOLATEX SDN. BHD. No 16, Jalan Bulan U5/5, Bandar Pinggiran Subang, Shah Alam, Selangor Darul Ehsan, MALAYSIA

Re: K012665

Trade/Device Name: Ultra Thin Latex Condom with Silicone Lubricant Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: 85 HIS Dated: August 10, 2001 Received: August 13, 2001

Dear Mr. Ah-Kau:

We have reviewed your Section 510(k) notification of intent to market the device referenced we have 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 Costicions of the Act. The general controls provisions of the Act include requirements for provisions of the read "The 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 (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.

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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 oungation you might 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) prematket notification. The FDA finding of substantial equivalence of your device to a legally marketed notheation. The I Driving of vasion for your device and thus, permits your device to proceed to the market.

Please be advised that, as of March 25, 1998, labeling for latex condoms (21 CFR §884.5300 and I loase be advinced analy with Use Labeling for Latex Condoms: Expiration Dating, 21 CFR \$801.435. Therefore, an expiration date, supported by test data developed under the 21 CF N 9001.435. Therefore, an inprint be displayed prominently and legibly on condom conditions specifical in 9001.455(d), mass of the effective shelf life of the spermicide must be compared with the shelf life of the condom and labeled with the earlier of the wood in 1066 dates. Although supporting data is not to be provided in your 510(k) submission, §801.435(j) uates. Andough supporting data and that it be available for inspection by FDA. Furthermore, 1001.435(e) requires that if your real-time test data fails to confirm the shelf life estimated by the methods in §801.435(d), then you must relabel all product to reflect the actual shelf life. medious in you i 193 (4), and your an expiration date that gives a shelf life more than five years.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please 11 you don't openite at [phone]. Additionally, for questions on the promotion connact also of your device, please contact the Office of Compliance at [phone]. Also, and advertising of your do rees, presso isbranding by reference to premarket notification"(21 CFR S807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone],or at its Internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Marcy Brogdon

Nancy C. Brogdon Director. Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

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K012665

## INDICATIONS FOR USE STATEMENT

NOV 0 9 2001

510(k) Number: K012665

Male Natural Rubber Latex Condom [No particular brand name] Device Name:

The [No particular brand name] condom is used for Indications For Use: contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases).

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR § 801.109) OR

Over-The-Counter Use

Counter Use

Nancy C. Hogdon
Division Sign-on

"sion of Reproduct · Radiological Devi . . (K) Number