KAREX INDUSTRIES MALE NATURAL RUBBER LATEX CONDOM, NON-SPERMICIDAL, LUBRICATED AND NON LUBRICATED

K081886 · Karex Industries Sdn. Bhd. · HIS · Feb 6, 2009 · Obstetrics/Gynecology

Device Facts

• Record ID: K081886
• Device Name: KAREX INDUSTRIES MALE NATURAL RUBBER LATEX CONDOM, NON-SPERMICIDAL, LUBRICATED AND NON LUBRICATED
• Applicant: Karex Industries Sdn. Bhd.
• Product Code: HIS · Obstetrics/Gynecology
• Decision Date: Feb 6, 2009
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 884.5300
• Device Class: Class 2

Intended Use

The Karex condom is used for contraceptive and for Prophylactic purposes { to help prevent pregnancy and the transmission of sexually transmitted diseases).

Device Story

Natural rubber latex sheath; straight-sided or contoured; textured or non-textured; includes reservoir tip. Nominal dimensions: 180mm length, 53mm width, 0.07mm thickness. Available non-lubricated or lubricated with silicone; cornstarch used as dressing. Offered in various colors and flavors. Used by individuals for contraception and STI prevention. Device acts as physical barrier. Biocompatibility confirmed per ISO 10993.

Clinical Evidence

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

Technological Characteristics

Natural rubber latex sheath; straight-sided or contoured; textured or non-textured; reservoir tip. Dimensions: 180mm length, 53mm width, 0.07mm thickness. Lubricated (silicone) or non-lubricated; cornstarch dressing. Conforms to ASTM D3492 and ISO 4074. Pigments and flavorings compliant with ISO 10993 and oral toxicity limits.

Indications for Use

Indicated for contraceptive and prophylactic purposes to help prevent pregnancy and the transmission of sexually transmitted diseases, including HIV, in individuals using male 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

• Latex Lubricated Condom Innolatex Sdn. Bhd. (K012962)
• K010919
• K053367
• Karex Industries Sdn. Bhd. (K070830)
• Dongkuk Techco Rubber Industries (K002060)

Submission Summary (Full Text)

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FEB - 6 2009

Page 5 of 22

1081886

#### Abbreviated 510(k) Notification for a Male Latex condom

#### II 510(k) SUMMARY

Submitted by :

Karex Industries Sdn. Bhd. PTD. 7906 & 7907 Taman Pontian Jaya, Bt. 34 Jalan Johor, 82000 Pontian, Johor, Malaysia.

Mr. Leng Kian Goh

Karex Industries Sdn. Bhd.

E-mail: Ik(@karex.com.my

General Manager

December 9, 2008.

Contact Persons :

Date Prepared :

Proprietary Name :

Common Name : Male Latex Condom

N/A.

Classification Name : Male latex Condom

Predicate Devices :

Latex Lubricated Condom Innolatex Sdn. Bhd. 510(k) Number = K012962 510(k) Number = K010919 510(k) Number = K053367

(Dotted Condoms) (Ribbed Condoms) (Non Lubricated Condoms)

Mary Goh

Quality Assurance Manager

Karex Industries Sdn. Bhd.

[e-mail]

Karex Industries Sdn. Bhd. 510(k) Number=K070830

(Colored and Flavored Condoms)

Dongkuk Techco Rubber Industries 510(k) Number = K002060 (Ribbed, Dotted & Contoured)

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Description of Device:

This condom is made of a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. This condom is straight sided or contoured , textured or non textured ,with a reservoir tip; nominal length 180mm, nominal width 53mm, and nominal thickness 0.07mm. It is nonlubricated or lubricated with silicone and cornstarch is used as a dressing material. The condom is either colored or non colored, flavored or non flavored, and designed to conform to established national and international voluntary standards including ASTM D3492 and ISO 4074.

Condoms will be offered in the following Color and Flavor. 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 condoms. The condom is used for contraception and for prophylactic purposes to help prevent pregnancy and the transmission of sexually transmitted diseases, including HIV.

Technological Characteristics:

This condom has the same technological characteristics 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 | 11767 | 12225-21-7 |
| Colany! Red FGRG 100 | 15850: 1 | N/A |
| Colanyl Green GG 131 | 77260 | 12001-99-9 |
| Colanyl Brown BM 100-ID | 77499 | 1317-61-9 |

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# Flavorings

### Description

Banana Strawberry Mint Chocolate

Banana Flavor Concentrate #8500 Strawberry Flavor Concentrate # 4837 Peppermint Flavor Oil #4608 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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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized emblem featuring three abstract shapes that resemble human figures or flowing lines. The emblem is black, and the text is also in black.

# FEB - 6 2009

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Mary Goh QA Manager Karex Industries SDN. BHD. PTD. 7906 & 7907 Taman Pontian Jaya Bt. 34 Jalan Johor, 82000 Pontian, Johor MALAYSIA

Re: K081886

Trade/Device Name: Male Natural Rubber Latex Condom

(Straight sided or Contoured in shape, either Textured or Non-Textured, Lubricated or Non-Lubricated, Non-colored or Colored and Flavored or Non-Flavored)

Regulation Number: 21 CFR §884.5300

Regulation Narne: Condom Regulatory Class: II Product Code: HIS Dated: January 22, 2009 Received: January 26, 2009

Dear Ms. 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 (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 os 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.xxx | (Gastroenterology/Renal/Urology) | [phone] |
|----------------|----------------------------------|----------------|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | [phone] |
| 21 CFR 892.xxx | (Radiology) | [phone] |
| Other | | [phone] |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (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 Manufactures, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrb/industry.suppot/index.html.

Sincerely yours,

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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Abbreviated 510(k) Notification for a Male latex Condom

#### INDICATIONS FOR USE STATEMENT VII

510(k) Number K081886

Device Name

Male Natural Rubber Latex Condom . (Straight sided or Contoured in shape, either Textured or Non-Textured, Lubricated or Non-Lubricated, Non-colored or Colored and Flavored or Non-Flavored).

Indications for Use:

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

X

Arzu K. Wum

(Division Sign-Off) Division of Reproductive. Abdominal. and Radiological Devi

510(k) Number.