M. DIOR BRAND

K083817 · Suzhou Colour-Way Enterprise Development Co., Ltd. · HIS · Sep 16, 2009 · Obstetrics/Gynecology

Device Facts

• Record ID: K083817
• Device Name: M. DIOR BRAND
• Applicant: Suzhou Colour-Way Enterprise Development Co., Ltd.
• Product Code: HIS · Obstetrics/Gynecology
• Decision Date: Sep 16, 2009
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 884.5300
• Device Class: Class 2

Intended Use

This latex condom has the same intended use as the predicate condom. The condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases.)

Device Story

Natural rubber latex sheath; straight-walled, nipple-end (SWNE) design; lubricated. Device covers penis to provide physical barrier. Used by individuals for contraception and prophylaxis against sexually transmitted infections. Over-the-counter availability.

Clinical Evidence

Bench testing only. Device conforms to ASTM D3492 and ISO 4074 standards for physical dimensions and material properties.

Technological Characteristics

Natural rubber latex material. Straight-walled, nipple-ended, lubricated form factor. Conforms to ASTM D3492 (min length 160mm, max width 54mm, min thickness 30µM) and ISO 4074 standards.

Indications for Use

Indicated for the prevention of pregnancy, HIV/AIDS, and other sexually transmitted infections. For over-the-counter use by the general population.

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.

Predicate Devices

• Latex Lubricated Condom (K071313)

Submission Summary (Full Text)

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## SEP 1 6 2009

## Section 7 510(k) Summary(rev.01)

[Refer to 21 CFR 807.92]

Submitted by:

Suzhou Colour-way Enterprise Development Co. Ltd QA Department Dongqiao Industrial Area, Suzhou, Jiangsu 215152.China,

Contact Person:

Date Prepared:

Proprietary Name:

Mr.Liu Songling

2009-08-20

m. Dior Brand or Private Label

Latex Condoms for Men

Latex Lubricated Condom

510(k) # K071313

Common Name:

Classification Name:

Condom (21 CFR 884.5300)

Predicate Device:

Description of the Device:

The condoms are made of a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. This condom is designed to conform to the standards including ASTM D3492 and ISO 4074. The condoms are smooth surface straight walled nipple-end (SWNE) style within ASTM standard specifications D-3492 Table 1 requirements, e.g., minimum length 160 mm, maximum width 54 mm, and minimum thickness of 30 µM.

Intended Use of the Device:

This latex condom has the same intended use as the predicate condom. The condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases.)

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Technological Characteristics: The 510(k) subject condom products have the same technological characteristics as the predicate condom products identified above. The design is in conformance with ASTM Latex Condom Standard D3492 and the condoms are made of natural rubber latex. both are straight-walled, nipple-ended, lubricated condoms and made using the same basic formulations of compounded natural rubber latex.

#### Indications for Use

M. Dior Brand Latex Condoms are intended to prevent pregnancy, HIV/AIDS, and other sexually transmitted infections.

The device is for over the counter use.

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Image /page/2/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with healthcare, with three parallel lines forming the staff and a winding shape at the bottom representing snakes. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular pattern around the caduceus.

### DEPARTMENT OF HEALTH & HUMAN SERVICES

#### Public Health Service

### SEP 1 6 2009

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002

Suzhou Colour-way Enterprise Development Co., Ltd. c/o Mr. Chu Xiaoan Beijing Easy-Link Company Room 1606, Bldg. 1, Jianxiang-Yuan No. 209 Bei Si Huan Zhong Road Haidian District, Beijing 100083 P. R. CHINA

Re: K083817

Trade/Device Name: M. Dior" Brand Male Latex Condom Regulation Number: 21 CFR §884.5300 Regulation Name: Condom Regulatory Class: II Product Code: HIS Dated: August 28, 2009 Received: September 1, 2009

Dear Mr. Xiaoan:

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. Iisting 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 (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.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical

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Page 2 .

device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting 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 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/MedicalDevices/Resourcesfor You/Industry/default.htm.

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Janine M. Morris

Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Section 8 Indications for Use Statement(rev01)

INDICATIONS FOR USE STATEMENT

510(k) Number:

K083817

Device Name:

m. Dior Brand Male Natural Rubber Latex Condom

Indications For Use:

m. Dior Brand Latex Condoms are intended to prevent pregnancy, HIV/AIDS, and other sexually transmitted infections.

The device is for over the counter use.

(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)

OR

Over-The-Counter Use_

X

Hublenn

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