MALE NATURAL RUBBER LATEX CONDOM (WITH COLORING AND FLAVORING)

K070830 · Karex Industries Sdn. Bhd. · HIS · May 8, 2007 · Obstetrics/Gynecology

Device Facts

• Record ID: K070830
• Device Name: MALE NATURAL RUBBER LATEX CONDOM (WITH COLORING AND FLAVORING)
• Applicant: Karex Industries Sdn. Bhd.
• Product Code: HIS · Obstetrics/Gynecology
• Decision Date: May 8, 2007
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 884.5300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

Natural rubber latex sheath; straight-walled, contoured, or flared design with reservoir tip; nominal length 180mm, width 53mm, thickness 0.06mm. Lubricated with silicone; includes cornstarch dressing. Available in various colors (yellow, red, green, brown) and flavors (banana, strawberry, mint, chocolate). Used by individuals for contraception and disease prevention. Device conforms to ASTM D3492 and ISO 4074 standards. Biocompatibility confirmed per ISO 10993.

Clinical Evidence

No clinical data. Bench testing only; device conforms to ASTM D3492 and ISO 4074 standards. Biocompatibility testing (cytotoxicity and sensitization) performed per ISO 10993.

Technological Characteristics

Natural rubber latex sheath; silicone lubricant; cornstarch dressing. Dimensions: 180mm length, 53mm width, 0.06mm thickness. Conforms to ASTM D3492 and ISO 4074. Pigments (CI 19140:1, 15850:1, 77289, 77499) and flavorings evaluated for biocompatibility per ISO 10993.

Indications for Use

Indicated for use by individuals for contraception and as a prophylactic to help prevent pregnancy and the transmission of sexually transmitted diseases, including HIV.

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 (K041837)

Submission Summary (Full Text)

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Page 4 of 14

2007 MAY 8

| II 510(k) SUMMARY | | | | | |
|-------------------|-----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|------------------------------------------------------------------------------------------|--|
| | Submitted by : | Karex Industries Sdn. Bhd.<br>PTD. 7906 & 7907<br>Taman Pontian Jaya,<br>Bt. 34 Jalan Johor,<br>82000 Pontian,<br>Johor, Malaysia. | | | |
| | Contact Persons : | Mr. Leng Kian Goh<br>General Manager<br>Karex Industries Sdn. Bhd.<br>E-mail: [e-mail] | | Mary Goh<br>Quality Assurance Manager<br>Karex Industries Sdn. Bhd.<br>[e-mail] | |
| | Date Prepared : | March 7, 2007. | | | |
| | Proprietary Name : | N/A. | | | |
| | Common Name : | Male Latex Condom | | | |
| | Classification Name : | Male latex Condom | | | |
| | Predicate Device : | Latex Lubricated Condom<br>Innolatex Sdn. Bhd.<br>510(k) Number = K041837 | | | |
| | Description of Device: | This condom is made of a natural rubber latex sheath, which<br>completely covers the penis with a closely fitted membrane.<br>This condom is straight walled, contoured or flared with a<br>reservoir tip; nominal length 180mm, nominal width 53mm,<br>and nominal thickness 0.06mm. It is lubricated with silicone<br>and cornstarch is used as a dressing material. The condom is<br>colored and flavored, and designed to conform to established<br>national and international voluntary standards including ASTM<br>D3492 and ISO 4074. | | | |
| | | Condoms will be offered in the following Color and Flavor.<br>Combinations: | | | |
| | | | Color | Flavor | |
| | | 1. | Yellow | Banana | |
| | | 2. | Red | Strawberry | |
| | | 3. | Green | Mint | |
| | | 4. | Brown | Chocolate | |
| | Intended Use of the Device: | This latex condom has the same intended use as the predicate<br>condoms. The condom is used for contraception and for<br>prophylactic purposes to help prevent pregnancy and the<br>transmission of sexually transmitted diseases, including HIV. | | | |

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Technological Characteristics: This condom has the same technological characteristics and use the same color pigments and flavorings (scents) as the predicate condoms identified above. The following Table provides a description of these colors and flavorings. The design of this condom is in conformance with ASTM Latex Condom Standard D3492 and the condom is made of natural rubber latex.

| Color Pigments | CI No. | CAS No. |
|-------------------------|---------|------------|
| Colanyl Yellow FGL 130 | 19140:1 | 12225-21-7 |
| Colanyl Red FGRG 100 | 15850:1 | N/A |
| Colanyl Green GG 131 | 77289 | 12001-99-9 |
| Colanyl Brown BM 100-ID | 77499 | 1317-61-9 |

## Flavorings Description

| Banana | Banana Flavor Concentrate #8500 |
|------------|-------------------------------------|
| Strawberry | Strawberry Flavor Concentrate #4837 |
| Mint | Peppermint Flavor Oil #4608 |
| Chocolate | Chocolate Flavor Oil #2141 |

The base formula was evaluated and confirmed to be in conformance with ISO 10993 biocompatibility requirements for cytotoxicity , and sensitization. The color pigments and flavorings have also been evaluated as part of the Predicate Device formulations and have been confirmed to be compliant with ISO 10993; and compliant with acceptable limits for oral toxicity.

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Image /page/2/Picture/1 description: The image shows a circular seal with text around the perimeter and a stylized eagle in the center. The text around the perimeter reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA". The eagle in the center is depicted with three curved lines representing its body and wings.

## MAY 8 2007

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

Mr. Leng Kian Goh General Manager Karex Industries Sdn. Bhd. PTD. 7906 & 7907 Taman Pontian Jaya Bt. 34. Jalan Johor 82000 Pontian JOHOR MALAYSIA

K070830 Re:

Trade/Device Name: Non-spermicidal Lubricated Male Latex Condom Colored and Scented Regulation Number: 21 CFR §884.5300 Regulation Name: Condom Regulatory Class: II Product Code: HIS Dated: March 7, 2007 Received: March 26, 2007

Dear Mr. Goh:

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 (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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Image /page/2/Picture/10 description: The image is a circular logo or seal, likely commemorating a centennial. The text "1906-2006" is at the top, indicating a 100-year period. The letters "FDA" are prominently displayed in the center, suggesting it is related to the Food and Drug Administration. The word "Centennial" is written below the letters, and three stars are underneath that. The text "Science at Your Service and Around" is written around the bottom of the circle.

Protecting and Promoting Public Health

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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 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" (21 CFR 807.97). 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 C. 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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K07C836

Abbreviated 510(k) Notification for a Male latex Condom

Page 11 of 14

## INDICATIONS FOR USE STATEMENT VII

| 510(k) Number | <del>Not Known</del> K070850 |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | Male Natural Rubber Latex Condom (with Coloring and Flavoring) |
| Indications for Use: | The Karex condom is used for contraceptive and for prophylactic purposes ( to help prevent pregnancy and the transmission of sexually transmitted diseases). |

## (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEED Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) OR

Over-the-Counter Use

Nancy C. Broadon

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Device

Radiological Devices
510(k) Number K70830