MALE NATURAL RUBBER LATEX CONDOM

K050244 · Nrs Global Partners · HIS · Apr 8, 2005 · Obstetrics/Gynecology

Device Facts

• Record ID: K050244
• Device Name: MALE NATURAL RUBBER LATEX CONDOM
• Applicant: Nrs Global Partners
• Product Code: HIS · Obstetrics/Gynecology
• Decision Date: Apr 8, 2005
• 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 condom. 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 latex sheath; covers erect penis; straight-sided, contoured, or flared; textured or non-textured; includes reservoir tip. Nominal dimensions: 180mm length, 53mm width, 0.07mm thickness. Lubricated with silicone or Astroglide; USP grade cornstarch dressing. Used by individuals for contraception and STI prevention. Device conforms to ASTM D3492 and ISO 4074 standards.

Clinical Evidence

Bench testing only; device conforms to ASTM D3492 and ISO 4074 standards.

Technological Characteristics

Natural rubber latex sheath; nominal length 180mm, width 53mm, thickness 0.07mm. Lubricated with silicone or Astroglide; USP grade cornstarch dressing. Design conforms to ASTM D3492 and ISO 4074.

Indications for Use

Indicated for use by males for contraception and prophylaxis 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

• Innolatex Male Latex Condom (K002393)

Submission Summary (Full Text)

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K050244

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

APR 8

2005

Page 5 of 13

| 510(k) SUMMARY | |
|--------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitted By: | NRS Global Partners Sdn Bhd<br>No. 30, Jalan 3/146, Bandar Tasik Selatan<br>5700 Kuala Lumpur, Malaysia |
| Contact Persons: | Eli J. Carter, Consultant<br>1219 Little Creek Road<br>Durham, NC 27713 |
| | Mr. Anthony Tan Jian Loong<br>Chief Operating Officer<br>NRS Global Partners Shn Bhd |
| Date Prepared: | January 31, 2005 |
| Proprietary Name: | None |
| Common Name: | Male Latex Condom |
| Classification Name: | Male Latex Condom |
| Predicate Device: | Innolatex Male Latex Condom; K002393 |
| 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 sided, contoured or flared in shape, either textured or non-<br>textured, with a reservoir tip; nominal length 180-mm, nominal width<br>53-mm, and nominal thickness 0.07mm. It is lubricated with silicone<br>or Astroglide™, and USP grade cornstarch is used as a dressing<br>material. This condom is designed to conform to established national<br>and international voluntary standards including ASTM D3492 and ISO<br>4074. |
| | This condom is identical to the predicate device with respect to<br>design, physical properties, and formulation. |
| Intended Use of the Device: | This latex condom has the same intended use as the predicate condom.<br>The condom is used for contraception and for prophylactic purposes to<br>help prevent pregnancy and the transmission of sexually transmitted<br>diseases, including HIV. |
| Technological Characteristics: | This condom has the same technological characteristics as the predicate<br>condom identified above. The design is in conformance with ASTM<br>Latex Condom Standard D3492 and that the condom is made of natural<br>rubber latex. |

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Image /page/1/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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NRS Global Partners Sdn Bhd % Mr. Eli Carter Consultant 1219 Little Creek Rd. DURHAM NC 27713

Re: K050244

2005

APR 8

Trade/Device Name: Male Natural Latex Condom Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: HIS Dated: January 31, 2005 Received: February 4, 2005

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 (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.

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 mis letter will and in your finding of substantial equivalence of your device to a legally promated modicate 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 11 you done 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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Page 11 of 13

K050244

## INDICATIONS FOR USE

| 510(k) Number: | Not Known K050244 |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Male Natural Rubber Latex Condom |
| Indications for Use: | The NRS Global Partners male latex condom is used for contraceptive<br>and for prophylactic purposes (to help prevent pregnancy and the<br>transmission of sexually transmitted diseases) |

Prescription Use (Per 21 CFR 801 Subpart D) 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)

Nancy C Brogdon

(Division Sign-Off) Division of Reproductive, Abdominal, And Radiological Devices

510(k) Number K050244