LOVE GUARD MALE LATEX CONDOM

K080833 · Tianjin Human-Care Latex Corporation · HIS · Aug 7, 2008 · Obstetrics/Gynecology

Device Facts

• Record ID: K080833
• Device Name: LOVE GUARD MALE LATEX CONDOM
• Applicant: Tianjin Human-Care Latex Corporation
• Product Code: HIS · Obstetrics/Gynecology
• Decision Date: Aug 7, 2008
• 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. This condom is used for contraception and for prophylactic purposes to help prevent pregnancy and the transmission of sexually transmitted diseases. If used properly, this condom will help to reduce the risk of transmission of HIV infection and many other sexually transmitted diseases including syphilis, chlamydia infections, genital herpes, genital warts, gonorrhea, hepatitis B. etc.

Device Story

Natural latex sheath; straight-walled with reservoir tip; covers penis as physical barrier. Used for contraception and STD prevention. Lubricated with polydimethylsiloxane (silicone); cornstarch dusting agent. Packaged in aluminum foil. Intended for over-the-counter use by individuals to reduce risk of pregnancy and disease transmission during sexual intercourse.

Clinical Evidence

Bench testing only. Device conforms to ASTM D3492 and ISO 4074 standards for air burst pressure and volume.

Technological Characteristics

Natural latex sheath; straight-walled; reservoir tip. Dimensions: 185-190mm length, 50.5-51.5mm width, 0.06-0.08mm thickness. Lubricant: Polydimethylsiloxane (silicone). Dusting agent: Cornstarch. Packaging: Aluminum foil. Conforms to ASTM D3492 and ISO 4074.

Indications for Use

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

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

• Lifestyles Male Latex Condom (K010371)

Submission Summary (Full Text)

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### KD80833

#### Abbreviated 510(k) for "Love Guard" Male Latex Condom

### 510(K) Summary for "Love Guard" Male Latex Condoms

AUG - 7 2008

| Submitted by: | Tianjin Human-care Latex Corporation<br>No 223, West 14 Road<br>Tianjin Airport Industrial Park<br>300308 Tianjin<br>People's Republic of China<br>Tel: [phone]<br>Fax: [phone] |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Mr. Pine Stone<br>Director, International Trade Department<br>Tianjin Human-care Latex Corporation<br>No 223, West 14 Road<br>Tianjin Airport Industrial Park<br>300308 Tianjin<br>People's Republic of China<br>Office phone: [phone] |
| Date Revised: | July 31st 2008 |
| Proprietary Name: | "Love Guard" Male Latex Condom |
| Common Name: | Male Latex Condom |
| Classification Name: | Condom (21 CFR §884.5300) |
| Predicate Device: | "Lifestyles" Male Latex Condom<br>Ansell Healthcare Products, LLC<br>510(k) Document Control Number: K010371 |

Description of the 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. Its nominal length is 185 - 190 mm, nominal width 50.5 -51.5 mm, and nominal thickness 0.06 - 0.08 mm. It is offered in natural latex color and lubricated with polydimethylsiloxane (silicone) with cornstarch as the

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dressing material. This condom is designed to conform to established American and international voluntary standards including ASTM D3492 and ISO 4074.

- Intended Use of the Device: This latex condom has the same intended use as the predicate condom. This condom is used for contraception and for prophylactic purposes to help prevent pregnancy and the transmission of sexually transmitted diseases. If used properly, this condom will help to reduce the risk of transmission of HIV infection and many other sexually transmitted diseases including syphilis, chlamydia infections, genital herpes, genital warts, gonorrhea, hepatitis B. etc.
- Technological Characteristics: This condom has the same technological characteristics as the predicate condom identified above. This condom is made of natural latex. Its design is in conformance with ASTM Latex Condom Standard D3492. The "Love Guard" Male Latex Condom to be introduced to the US market is similar to the predicate device in terms of the intended use, method of operation, materials, design, etc. Therefore, there is no significant difference between the "Love Guard" Male Latex Condom and the predicate device in the areas of safety and effectiveness.

| Features | "Love Guard" Condom | "Lifestyles" Condom |
|--------------------------|---------------------------------------------------------|---------------------|
| Length (mm) | 185 - 190 | 182 -190 |
| Width (mm) | 50.5 - 51.5 | 51 - 52 |
| Thickness (mm) | 0.06 - 0.08 | 0.05 |
| Air burst pressure (kPa) | 1.35 - 2.55 | 0 - 2.85 |
| Air burst volume (dm³) | 20.0 - 58.5 | 0 - 47 |
| Package materials | Aluminum foil | Aluminum foil |
| Lubricant system | Polydimethylsiloxane (silicone)<br>Viscosity: 300 mPa.S | Glycerin-based |
| Dusting agent | Cornstarch | Cornstarch |
| Reservoir tip | Yes | Yes |

The similarities of the features and technological characteristics of "Love Guard" Male Latex Condom in comparison to the predicate condom are summarized as follows:

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### 510(K) Summary for "Love Guard" Male Latex Condoms

| Submitted by: | Tianjin Human-care Latex Corporation<br>No 223, West 14 Road<br>Tianjin Airport Industrial Park<br>300308 Tianjin<br>People's Republic of China<br>Tel: [phone]<br>Fax: [phone] |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Mr. Pine Stone<br>Director, International Trade Department<br>Tianjin Human-care Latex Corporation<br>No 223, West 14 Road<br>Tianjin Airport Industrial Park<br>300308 Tianjin<br>People's Republic of China<br>Office phone: [phone] |
| Date Revised: | July 31st 2008 |
| Proprietary Name: | "Love Guard" Male Latex Condom |
| Common Name: | Male Latex Condom |
| Classification Name: | Condom (21 CFR §884.5300) |
| Predicate Device: | "Lifestyles" Male Latex Condom<br>Ansell Healthcare Products, LLC<br>510(k) Document Control Number: K010371 |

Description of the 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. Its nominal length is 185 - 190 mm, nominal width 50.5 -51.5 mm, and nominal thickness 0.06 - 0.08 mm. It is offered in natural latex color and lubricated with polydimethylsiloxane (silicone) with cornstarch as the

{3}------------------------------------------------

dressing material. This condom is designed to conform to established American and international voluntary standards including ASTM D3492 and ISO 4074.

- Intended Use of the Device: This latex condom has the same intended use as the predicate condom. This condom is used for contraception and for prophylactic purposes to help prevent pregnancy and the transmission of sexually transmitted diseases. If used properly, this condom will help to reduce the risk of transmission of HIV infection and many other sexually transmitted diseases including syphilis, chlamydia infections, genital herpes, genital warts, gonorrhea, hepatitis B. etc.
- Technological Characteristics: This condom has the same technological characteristics as the predicate condom identified above. This condom is made of natural latex. Its design is in conformance with ASTM Latex Condom Standard D3492. The "Love Guard" Male Latex Condom to be introduced to the US market is similar to the predicate device in terms of the intended use, method of operation, materials, design, etc. Therefore, there is no significant difference between the "Love Guard" Male Latex Condom and the predicate device in the areas of safety and effectiveness.

| Features | "Love Guard" Condom | "Lifestyles" Condom |
|--------------------------|---------------------------------------------------------|---------------------|
| Length (mm) | 185 - 190 | 182 -190 |
| Width (mm) | 50.5 - 51.5 | 51 - 52 |
| Thickness (mm) | 0.06 - 0.08 | 0.05 |
| Air burst pressure (kPa) | 1.35 - 2.55 | 0 - 2.85 |
| Air burst volume (dm³) | 20.0 - 58.5 | 0 - 47 |
| Package materials | Aluminum foil | Aluminum foil |
| Lubricant system | Polydimethylsiloxane (silicone)<br>Viscosity: 300 mPa.S | Glycerin-based |
| Dusting agent | Cornstarch | Cornstarch |
| Reservoir tip | Yes | Yes |

The similarities of the features and technological characteristics of "Love Guard" Male Latex Condom in comparison to the predicate condom are summarized as follows:

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# K080833

#### INDICATIONS FOR USE STATEMENT VII.

510(k) Number:

"Love Guard" Male Latex Condom Device Name:

Indication For Use: This latex condom has the same intended use as the predicate condom. This condom is used for contraception and for prophylactic purposes to help prevent pregnancy and the transmission of sexually transmitted diseases. If used properly, this condom will help to reduce the risk of transmission of HIV infection and many other sexually transmitted diseases including syphilis, chlamydia infections, genital herpes, genital warts, gonorrhea, hepatitis B. etc.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR §801.109)

OR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

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Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the top half of the circle. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines that suggest wings and a tail.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG - 7 2008

Tianjin Human-Care Latex Corporation c/o Simon Li, MD, PhD Lift International, Inc. 56 Danville Drive WEST WINDSOR NI 08550

Re: K080833

Trade Name: "Love Guard" Male Latex Condom Regulation Number: 21 CFR 884.5300 Regulation Name: Male Latex Condom Regulatory Class: II Product Code: HIS Dated: June 10, 2008 Received: June 12, 2008

Dear Dr. Li:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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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 electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on 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" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/cdrh/industry/support/index.html.

Sincerely yours,

Nancy Brogdon

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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## K 080833

#### INDICATIONS FOR USE STATEMENT VII.

510(k) Number:

"Love Guard" Male Latex Condom Device Name:

K080833

Indication For Use: This latex condom has the same intended use as the predicate condom. This condom is used for contraception and for prophylactic purposes to help prevent pregnancy and the transmission of sexually transmitted diseases. If used properly, this condom will help to reduce the risk of transmission of HIV infection and many other sexually transmitted diseases including syphilis, chlamydia infections, genital herpes, genital warts, gonorrhea, hepatitis B. etc.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR §801.109)

OR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________ X

Hula Lemen

ivision Sign-Off Division of Reproductive. Abdomin and Radiological D 510(k) Number