REMED MALE DOTTED CONDOM PREVENTOR, LUCKY BOY, SUMMIT

K993405 · Remed Pharma · HIS · Feb 15, 2000 · Obstetrics/Gynecology

Device Facts

• Record ID: K993405
• Device Name: REMED MALE DOTTED CONDOM PREVENTOR, LUCKY BOY, SUMMIT
• Applicant: Remed Pharma
• Product Code: HIS · Obstetrics/Gynecology
• Decision Date: Feb 15, 2000
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 884.5300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Remed Preventor Dotted Condom is made of a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. The Preventor Dotted condom is a dotted surfaced condom with no color additives, and is used for contraception and to help prevent the transmission of sexually transmitted diseases.

Device Story

Remed Pharma Male Dotted Condom consists of a natural rubber latex sheath designed to cover the penis. Device features a dotted surface texture and contains no color additives. Used for contraception and reduction of sexually transmitted disease transmission. Intended for over-the-counter use by male consumers.

Clinical Evidence

No clinical data provided; device relies on established material safety and performance standards for latex condoms.

Technological Characteristics

Material: Natural rubber latex. Form factor: Sheath with dotted surface. No color additives. Regulated under 21 CFR 884.5300.

Indications for Use

Indicated for use by males for contraception and to help prevent the transmission of sexually transmitted diseases.

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.

Submission Summary (Full Text)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol 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.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 5 2000

Remed Pharma c/o E. J. Smith Consultant Smith Associates P.O. Box 4341 Crofton, MD 21114 Re: K993405 Remed Pharma Male Dotted Rubber Latex Condom Dated: December 20, 1999 Received: December 21, 1999 Requiatory Class: II 21 CFR §884.5300/Procode: 85 HIS

Dear Mr. Smith:

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 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 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 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.

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Page 2 - Mr. E. J. Smith

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 Assistance at its toll-free number [phone] or [phone],or at its Internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

/2r

CAPT Daniel G. Schultz, M.D. Acting Director

Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

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# INDICATION FOR USE STATEMENT

**510(K) Number (if known):** K992405

Device Name: Remed Pharma Male Dotted Condom

### Indications for Use:

The Remed Preventor Dotted Condom is made of a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. The Preventor Dotted condom is a dotted surfaced condom with no color additives, and is used for contraception and to help prevent the 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)

Prescription Use

or

**Over-the-Counter Use**

David L. Segerson
Division Sign Off

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

510(k) Number K943405