MALE LATEX CONDOM

K012653 · Qingdao Shuang Die Latex Production Co.,Ltd · HIS · Sep 21, 2001 · Obstetrics/Gynecology

Device Facts

• Record ID: K012653
• Device Name: MALE LATEX CONDOM
• Applicant: Qingdao Shuang Die Latex Production Co.,Ltd
• Product Code: HIS · Obstetrics/Gynecology
• Decision Date: Sep 21, 2001
• 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. If properly used, this condom will help reduce the risk of pregnancy without the serious side effects sometimes associated with other contraceptive methods.

Device Story

Male latex condom; straight-walled with reservoir tip; natural rubber latex membrane; lubricated with silicone. Designed for use by individuals to cover erect penis. Functions as physical barrier for contraception and prevention of sexually transmitted diseases. Conforms to ASTM D3492, ISO 4074, and EN 600 standards.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Natural rubber latex material; straight-walled design with reservoir tip; silicone lubricant. Conforms to ASTM D3492, ISO 4074, and EN 600 standards. Class II device.

Indications for Use

Indicated for contraception and prophylactic purposes 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 (K994095)

Submission Summary (Full Text)

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# SEP 2 1 2001

# Abbreviated 510(k) Notification for a Male Latex Condom KOloGS3 Page 5 of 13

#### II. 510(k) Summary

| Submitted By: | Quingdao Shuang Die Latex Production Co. Ltd.<br>No. 103 Taidongyi Road<br>Qingdao, China<br>Telephone: [phone] (US) | |
|--------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Eli J. Carter<br>Consultant<br>1219 Little Creek Road<br>Durham, NC 27713<br>Telephone: [phone] | Michael Park<br>President, Import/Export<br>EC Plaza USA, Inc.<br>3333 Wilshire Blvd.<br>Los Angeles, CA 90010<br>Telephone: [phone] |
| Date Prepared: | August 8, 2001 | |
| Proprietary Name: | Various Brand Names | |
| Common Name: | Latex Condom | |
| Classification Name: | Condom (21 CFR 884.5300) | |
| Predicate Device: | Thai Nippon Male Latex Condom<br>510(k)# K994095 | |
| Description of Device: | This condom is made of a natural rubber latex, which<br>completely covers the erect penis with a closely fitted<br>membrane. This condom is straight-walled with a reservoir<br>tip, and is designed to conform to established national and<br>international voluntary standards including ASTM D3492,<br>ISO 4074, and EN 600. This condom is lubricated with<br>silicone. | |
| Intended Use of the Device: | This latex condom has the same intended use as the predicate<br>condom. 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.<br>If properly used, this condom will help reduce the risk of<br>pregnancy without the serious side effects sometimes<br>associated with other contraceptive methods. | |
| Technological Characteristics: | This condom has the same technological characteristics as the<br>predicate condom identified above. The design of both<br>products conforms with ASTM Latex Condom Standard<br>D3492 and the condom is made of natural rubber latex. | |

. .

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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines beneath them.

### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# SEP 2 1 2001

Oingdao Shuang Die Latex Production Co., Ltd. % Mr. Eli J. Carter Consultant to Qingdao Shuang 1219 Little Creek Road DURHAM NC 27713

Re: K012653

Trade/Device Name: Male Latex Condom Regulation Number:_21 CFR 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: 85 HIS Dated: August 8, 2001 Received: August 13, 2001

Dear Mr. Carter:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed

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### Page 2 - Mr. Eli J. Carter

predicate device results in a classification for your device and thus, permits your device to proceed to the market.

Please be advised that, as of March 25, 1998. labeling for latex condoms (21 CFR 884.5300 and 884.5310) must comply with Use Labeling for Latex Condoms: Expiration Dating, 21 CFR 801.435. Therefore, an expiration date, supported by test data developed under the conditions specified in 801.435(d), must be displayed prominently and legibly on condom labeling. For condoms with spermicidal lubricant, the effective shelf life of the spermicide must be compared with the shelf life of the condom and labeled with the earlier of the two expiration dates. Although supporting data is not to be provided in your 510(k) submission, 801.435(j) requires that you maintain this data and that it be available for inspection by FDA. Furthermore, 801.435(e) requires that if your real-time test data fails to confirm the shelf life estimated by the methods in 801.435(d), then you must relabel all product to reflect the actual shelf life. Condoms are not to be labeled with an expiration date that gives a shelf life more than five years.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained 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/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

Evelinne

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Loi2ioS3

## Information for a Male Latex Condom 510(k) Submission

Page 11 of 13

### INDICATIONS FOR USE STATEMENT VII.

| 510(K) Number | Not Known |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | Male Natural Rubber Latex Condom (Various Brand Names) |
| Indications for Use | The Qingdao Shuang condom is used for contraception and for<br>prophylactic purposes (to help prevent pregnancy and the<br>transmission of sexually transmitted diseases). |

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

(Per 21 CFR 801.109)

| (Division Sign-Off) | |
|---------------------------------------------------------------|---------|
| Division of Reproductive, Abdominal, and Radiological Devices | |
| 510(k) Number | K012653 |

Over-the-Counter Use

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OR

Prescription Use -------------------------------------------------------------------------------------------------------------------------------------------------------------