LATEX MALE CONDOM (SMOOTH SURFACE) LATEX MALE CONDOM (TEXTURED SURFACE)

K120555 · Medical-Latex (Dua) Sdn. Bhd · HIS · Nov 2, 2012 · Obstetrics/Gynecology

Device Facts

• Record ID: K120555
• Device Name: LATEX MALE CONDOM (SMOOTH SURFACE) LATEX MALE CONDOM (TEXTURED SURFACE)
• Applicant: Medical-Latex (Dua) Sdn. Bhd
• Product Code: HIS · Obstetrics/Gynecology
• Decision Date: Nov 2, 2012
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 884.5300
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Medical Latex (DUA) condom is used for contraceptive and prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases).

Device Story

CARE Condom is a latex barrier device designed for contraceptive and prophylactic use. Available in multiple variants including smooth (superthin, regular, retarding) and textured (ribbed, ribbed/dotted/flared) surfaces. Intended for over-the-counter use by individuals to prevent pregnancy and transmission of sexually transmitted diseases.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Latex material; barrier device; various surface textures (smooth, ribbed, dotted, flared).

Indications for Use

Indicated for individuals seeking contraception and protection against 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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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

Letter Date: November 2, 2012.

Medical-Latex (DUA) SDN. BHD % Ms. Uma Devi Assistant Manager - QA/ RA Plo 8 Senai Industrial Estate SENAI JOHOR MALAYSIA 81400

Re: K120555

Trade/Device Name: CARE Condom Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: HIS Dated: October 17, 2012 Received: October 22, 2012

Dear Ms. Devi:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Ms. Uma Devi

Please be advised that FDA's issuance of a substantial equivalence determination does not mean i lease of advisou that I be intent that your device complies with other requirements of the Act that I Dr Hab Intact and regulations administered by other Federal agencies. You must or any I catal statutes and regaranents, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical CI K Fart 607), aboning (21 CFR 803); good manufacturing practice requirements as set de rice-related daverse oreals) (1) OFF Part 820); and if applicable, the electronic form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please 11 you desire specific and to boutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please the Ocher for Doviets and And Andrew by reference to premarket notification" (21CFR Part now the regulation online of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the I va may of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

## Benjamin R. Fisher -S

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Beiersdorf

OUAL SON BHD Reg. No. 163948

Plo 8 Senai Industrial Esta 81400 Senai Johor Malaysia ([phone] Tel [phone] Fax E-mail Medical-Latexto Be

## Indications for Use

510(k) Number (K120555):

Device Name: CARE Condom

- Smooth Surface
- Superthin condom
- Regular condom
- Retarding condom
- 2. Textured surface
- a. Stimulating(ribbed) condom
- G-Pleasure(ribbed ,dotted and flared) condom

Indications For Use: The Medical Latex (DUA) condom is used for contraceptive and prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases).

AND/OR Over-The Counter Use 日 Prescription Use Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE

Benjamin R. Fisher -S 2012.11.02 14:34:20 -04'00'

Division Sign-Off) ion of Reproductive, Gastro-Renal, and Urological Devices