TULIP CONDOM

K050360 · Shanghai Latex Factory · HIS · Mar 1, 2005 · Obstetrics/Gynecology

Device Facts

• Record ID: K050360
• Device Name: TULIP CONDOM
• Applicant: Shanghai Latex Factory
• Product Code: HIS · Obstetrics/Gynecology
• Decision Date: Mar 1, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5300
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Indications for Use

The condom is used for contraception and for prophylactic purposes to help prevent pregnancy and the transmission of sexually transmitted diseases. If used properly, latex condoms will help to reduce the risk of transmission of HIV infection (AIDS) and many other sexually transmitted diseases including chlamydia infections, genital herpes, genital warts, gonorrhea, hepatitis B, and syohilis. In addition, this condom will help to reduce the risk of transmission of HIV infection (AIDS) and many other sexually transmitted diseases.

Device Story

Tulip Condom is a natural rubber latex sheath designed to cover the penis. Features include straight-walled geometry, reservoir tip, 180mm length, 52mm width, and 0.05mm thickness. Lubricated with silicone and dressed with cornstarch. Used by individuals for contraception and prevention of sexually transmitted diseases. Device acts as a physical barrier to prevent exchange of bodily fluids during intercourse. Conforms to ASTM D3492 and ISO 4074 standards.

Clinical Evidence

Bench testing only. Device performance verified against ASTM D3492 and ISO 4074 standards, including air burst pressure (2.3 kPa) and air burst volume (38.5 dm³).

Technological Characteristics

Natural rubber latex sheath; straight-walled with reservoir tip; 180mm length, 52mm width, 0.05mm thickness; silicone lubricant; cornstarch dressing. Conforms to ASTM D3492-02 and ISO 4074-1-1996 standards.

Indications for Use

Indicated for contraception and prophylaxis to prevent pregnancy and transmission of sexually transmitted diseases (including HIV/AIDS, chlamydia, genital herpes, genital warts, gonorrhea, hepatitis B, and syphilis) 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.

Predicate Devices

• Latex Condom (K994118)

Submission Summary (Full Text)

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MAR 1 - 2005

Image /page/0/Picture/1 description: The image shows a sequence of handwritten alphanumeric characters. The characters appear to be "K050360D". The characters are written in a cursive style, and the image is in black and white.

# SHANGHAI LATEX FACTORY

Abbreviated 510(k) for Male Latex Condoms

#K_

#### 510(k) SUMMARY 川 .

| Submitted By: | Shanghai Latex Factory<br>1700, Huangxing road, Shanghai, China, 200433<br>Telephone: [phone]<br>Fax: [phone] | | |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|
| Contact Person: | Mr. Lou Ji | | |
| Date Prepared: | December 20, 2004 | | |
| Proprietary Name: | Tulip Condom | | |
| Common Name: | Latex Male Condom | | |
| Classification Name: | Condom (21 CFR 884.5300) | | |
| Predicate Device: | Latex Condom<br>510(k) #K[994118] | | |
| Description of Device: | This condom is made of a natural latex sheath, which completely covers the penis with a closely fitted membrane. This condom is straight-walled with a reservoir tip, nominal length 180mm, nominal width 52mm, and nominal thickness 0.05mm. It is lubricated with silicon, with cornstarch as a dressing material. The condom is offered in natural latex color and is designed to conform to established American and international voluntary standards including ASTM D3492-02 and ISO 4074-1-1996 | | |

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### Abbreviated 510(k) for Male Latex Condoms

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This lates condom has the same intended use as the predicate Intended Use of the Device: The condom is used for contraception and for condom. prophylactic purposes to help prevent pregnancy and the transmission of sexually transmitted diseases. If used properly, latex condoms will help to reduce the risk of transmission of HIV infection (AIDS) and many other sexually transmitted diseases including chlamydia infections, genital herpes, genital warts, gonorrhea, hepatitis B, and syohilis. In addition, this condom will help to reduce the risk of transmission of HIV infection (AIDS) and many other sexually transmitted diseases.

Technological Characteristics: This condom has the same technological characteristics as the identified predicate condom above. The design İs 1 (1 conformance with ASTM Latex Condom Standard 03492 and that the condom is made of natural rubber latex. Accordingly, when compared to the predicate device, the tulip condom intended to be introduced does not incorporate any significant changes in the intended use, method of operation, materials, or design that could affect safety and effectiveness.

| Feature | Tulip Condom | Predicate Device |
|-------------------------|--------------|------------------|
| Length (mm) | 180 | 180 |
| Width (mm) | 52 | 52 |
| Thickness (mm) | 0.05 | 0.05 |
| Air Burst Pressure(kPa) | 2.3 | 2.4 |
| Air Burst Volume (dm³) | 38.5 | 36 |
| Lubricant System | Silicone | Silicone |
| Reservoir Tip | Yes | Yes |

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Shanghai Latex Factory % Ms. Laura L. Danielson Responsible Third Party Official 510(k) Program Manager TÜV Product Service 1775 Old Highway 8 NEW BRIGHTON MN 55112-1891 Re: K050360

MAR 1 - 2005

Trade/Device Name: Tulip Condom Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: 85 HIS Dated: February 11, 2005 Received: February 14, 2005

Dear Ms. Danielson:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced we have 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 the cherosate) to regulary ment date of the Medical Device Amendments, or to devices that have been recy 20, 1770, the chance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that recrassmod in accordal of a premarket approval application (PMA). You may, therefore, market the do not require 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 . In addition, 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the clectronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to begin marketing of substantial equivalence of your device to a legally premarket notification. The FDA Inding of substantial organities 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), pleased on the regulation numer If you desire specific advice for your device on our labering regulation in the regulation number at the top of this letter:

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Also, please note the regulation entired, "Nisoration on your responsibilities under the Act from the 807.97). You may obtain other general mannation on your of its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Nancy C. Hogdon

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

Enclosure

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## SHANGHAI LATEX FACTORY

Abbreviated 510(k) for Male Latex Condoms

માં આ

INDICATIONS FOR USE STATEMENT VII.

## Indications for Use

K050360 510(k) Number (if known):

Device Name: Tulip Condom __

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

Prescription Use - - - -(Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Otlice of Device Evaluation (ODE)

David R. Lyson

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

No. 1700, Huangxing Road, Shanghai, P.R.China

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