SURE

K982380 · Pleasure Latex Products Sdn. Bhd. · HIS · Feb 26, 1999 · Obstetrics/Gynecology

Device Facts

• Record ID: K982380
• Device Name: SURE
• Applicant: Pleasure Latex Products Sdn. Bhd.
• Product Code: HIS · Obstetrics/Gynecology
• Decision Date: Feb 26, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

When used in accordance with manufacturer's instruction, condoms are effective form of contraception. If used properly, latex condoms will help to reduce the risk of transmission of HIV infection (AIDS) and many other sexually transmitted diseases, including chlamydia, genital warts, gonorthea, hepatitis B and syphilis.

Device Story

The "SURE" Condom is a natural rubber latex contraceptive device. It is intended for over-the-counter use by individuals to prevent pregnancy and reduce the risk of sexually transmitted diseases. The device functions as a physical barrier. It is a mechanical device and does not involve electronic components, software, or automated analysis.

Clinical Evidence

No clinical data provided; device is a standard natural rubber latex contraceptive subject to general controls and labeling requirements.

Technological Characteristics

Natural rubber latex contraceptive; physical barrier device; no electronic components, software, or energy source.

Indications for Use

Indicated for use as a contraceptive and to help reduce the risk of transmission of HIV (AIDS) and other sexually transmitted diseases (chlamydia, genital warts, gonorrhea, hepatitis B, syphilis).

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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 26 1999

Mr. Chang Ah Kau Managing Director Pleasure Latex Products SDN. BHD. Wisma Kossan, Lot 782 Jalan Sungai Putus, Off Batu 3% Jalan Kapar, 42100-Klang Selangor Darul Ehsan, MALAYSIA

Re: K982380

"SURE" Condom (Natural Rubber Latex Contraceptive) Dated: December 5, 1998 Received: December 7, 1998 Regulatory Class: II 21 CFR 884.5300/Procode: 85 HIS

Dear Mr. Kau:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have we nave lovice is substantially equivalent (for the indications for use stated in the enclosure) to legally decemmited the devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the makeed predicate ac necess that have been reclassified in accordance with the provisions of the Medical Device Amendinons, or to corress and su way, therefore, market the device, subject to the general controls records of the Act. The general controls provisions of the Act include requirements for annual registration, provisions of alle ret. "The generice, 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 If your dorited to such additional controls. Existing major regulations affecting your device can be found in the may of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes could of Pederal Regulations, Practice requirements, as set forth in the Quality System Complation (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 inspections, the Food and Drig 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 I rease note. " and response to your premation 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 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 I teast be advised that, as of Material on Dating, 21 CFR 801.435. Therefore, an expiration date, comply with bot Batoning 2012 and e the conditions specified in 801.435(d), must be displayed prominently and supported by test and developed and with spermicidal lubricant, the effective shelf life of the spermicide must tics of on other habeling." I of the condom and labeled with the earlier of the two expiration dates. Although ov compared with the there in your 510(k) submission, 801.435(j) requires that you maintain this data and supporting add is for inspection by FDA. Furthermore, 801.435(e) requires that if your real-time test data fails to ular it oc uvaluation for inspocusiny the methods in 801.435(d), then you must relabel all product to reflect the actual confirm the sitent into estimated of the meason an expiration date that gives a shelf life more than five years.

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## Page 2 - Mr. Chang Ah Kau

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office If you desire specific advice tor your dorned on our raveling on the promotion and advertising of your device, of Compliance at [phone]. Industry, sol 4639. Also, please note the regulation entitled, "Misbranding prease connect the Office of Compilation at (2017). Other general information on your responsibilities under by recreated to promance from the Division of Small Manufacturers Assistance at its toll-free number the Accinay be obtained from the Drivien of emat address "http://www.fda.gov/cdrh/dsmaldsmamain.html".

**Sincerely yours,**

UN 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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510 (k) Number ( if known ): _________________________________________________________________________________________________________________________________________________

K982380

Device Name : _ CONDOM ( NATURAL RUBBER LATEX CONTRACEPTIVE )

Indication For Use:

When used in accordance with manufacturer's instruction, condoms are effective form of contraception.

If used properly, latex condoms will help to reduce the risk of transmission of HIV infection (AIDS) and many other sexually transmitted diseases, including chlamydia, genital warts, gonorthea, hepatitis B and syphilis.

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

Concurrence of CDRH, Office of Device Evaluation ( ODE )

Prescription Use ( Per 21 CFR 801.109 ) Over - The Counter Use

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OR

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