INNOLATEX MALE LATEX CONDOMS COLORED AND SCENTED

K041837 · Innolatex Sdn. Bhd · HIS · Sep 24, 2004 · Obstetrics/Gynecology

Device Facts

• Record ID: K041837
• Device Name: INNOLATEX MALE LATEX CONDOMS COLORED AND SCENTED
• Applicant: Innolatex Sdn. Bhd
• Product Code: HIS · Obstetrics/Gynecology
• Decision Date: Sep 24, 2004
• 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 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; covers erect penis; straight-walled or contoured with reservoir tip; nominal length 180mm, width 52mm, thickness 0.06mm. Lubricated with silicone; cornstarch dressing. Available in colored/flavored variants (Yellow Banana, Red Strawberry, Green Mint, Black Chocolate). Used by individuals for contraception and STI prevention. Device conforms to ASTM D3492 and ISO 4074 standards. Biocompatibility confirmed per ISO 10993.

Clinical Evidence

No clinical data. Biocompatibility evaluation performed per ISO 10993 requirements for cytotoxicity and sensitization. Color pigments and flavorings evaluated for oral toxicity and confirmed compliant with ISO 10993.

Technological Characteristics

Natural rubber latex sheath; nominal dimensions 180mm length, 52mm width, 0.06mm thickness. Lubricated with silicone; cornstarch dressing. Conforms to ASTM D3492 and ISO 4074. Biocompatible per ISO 10993. Includes specific color pigments (CI 19140:1, 15850:1, 77289, 77499) and flavorings.

Indications for Use

Indicated for contraception and prophylaxis to help prevent pregnancy and the transmission of sexually transmitted diseases, including HIV, in individuals using male latex condoms.

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

• Thai Nippon Male Latex Condom (K011253)
• UNIDUS Male Latex Condom (K023175)

Submission Summary (Full Text)

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K041837

II.

| 510(k) SUMMARY | | | | | | | | | | | | | | | | |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|
| Submitted By: | Innolatex SDN, BHD.<br>Lot 594, Persiaran Raja Lumu,<br>Pandamaran Industrial Estate<br>42000 Port Klang, Selandgor Darul Ehsan<br>Malaysia | | | | | | | | | | | | | | | |
| Contact Persons: | Eli J. Carter<br>Technical Consultant<br>1219 Little Creek Road<br>Durham, NC 27713<br>Telephone: [phone]<br>Email: [e-mail] | | | | | | | | | | | | | | | |
| | Mr. Goh Miah Kiat<br>General Manager<br>Innolatex SDN, BHD | | | | | | | | | | | | | | | |
| Date Prepared: | June 30, 2004 | | | | | | | | | | | | | | | |
| Proprietary Name: | N/A | | | | | | | | | | | | | | | |
| Common Name: | Male Latex Condom | | | | | | | | | | | | | | | |
| Classification Name: | Male Latex Condom | | | | | | | | | | | | | | | |
| Predicate Devices: | Thai Nippon Male Latex Condom: K011253<br>UNIDUS Male Latex Condom: K023175 | | | | | | | | | | | | | | | |
| Description of Device: | This condom is made of a natural latex sheath, which completely<br>covers the erect penis with a closely fitted membrane. This condom is<br>straight-walled or contoured with a reservoir tip; nominal length<br>180mm, nominal width 52mm, and nominal thickness 0.06mm. It is<br>lubricated with silicone and cornstarch is used as a dressing material.<br>This condom is colored and flavored, and designed to conform to<br>established national and international voluntary standards including<br>ASTM 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. Black Chocolate | | | | | | | | | | | | | | | |

Intended Use of the Device:

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.

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Technological Characteristics:

This condom has the same technological characteristics and uses 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 Pigment | 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 the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 4 2004

Innolatex SDN, BHD. c/o Mr. Eli J. Carter Technical Consultant to Innolatex 1219 Little Creek Road DURHAM NC 27713

Re: K041837

Trade/Device Name: Male Natural Rubber Latex Condom (with Coloring & Flavoring) Regulation Number: 21 CFR §884.5300 Regulation Name: Condom Regulatory Class: II Product Code: 85 HIS Dated: June 30, 2004 Received: July 7, 2004

Dear Mr. Carter:

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 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); 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.

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This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to ocgin maries.g of substantial equivalence of your device to a legally premarket notheation. The PDA masmis cation 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 If you desire specific advice for your dones on the wing numbers, based on the regulation number at the top of the letter:

| 8xx.1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Additionally, 101 questions on the president ................................................................................................................................. Other of Compliance at (501) 57 - 100 - 100 - 100 807.97) you may obtain. Other general by relected to premarks ander the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or Manutacturers, International and Goldamhttp://www.fda.gov/cdrt/dsma/dsmamain.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

Page 2

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## Indications for Use

| 510(k) Number: | K041837 |
|----------------|--------------------------------------------------------------|
| Device Name: | Male Natural Rubber Latex Condom (with Coloring & Flavoring) |

| Indications for Use: | The Innolatex condom is used for contraceptive and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases). |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|

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

Over-the-Counter Use _ (21 CFR 801 Subpart C)

.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel R. Symon

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number. K041837