IL 510(k) SUMMARY
Submitted by: Ansell Healthcare Products LLC
1635 Industrial Road
Dothan, AL 36303
USA
Contact Person Lon D. McIlvain
Vice President, Regulatory Affairs Global
Telephone: 334-794-4231 or 334-615-2562
Fax: 334-615-2568
Date Prepared: December 13, 2006
Proprietary Name: LifeStyles Lubricated Polyisoprene Latex Male Condom
Common Name: Male latex condom
Classification Name: Condom (21 CFR 884.5300)
Predicate Device: Suretex Ltd., Latex Condoms with Silicone Oil Lubricant
510(k) Document Control Number K941258
Description of the Device:
The LifeStyles condom is a male contraceptive and prophylactic device fabricated
from synthetic rubber polyisoprene latex with a lubricant coating. The condom is
a fitted sheath with an integral ring at the open end and a reservoir (nipple-end) at
the closed end to contain semen. The condom has a nominal length of 185 mm
and nominal width of 53 mm. The condom is designed to conform to established
national and international voluntary standards including ASTM D3492 Standard
Specification for Rubber Contraceptives (Male Condoms) and ISO
4074:2002Cor.1:3002(E): Natural Latex Rubber Condoms - Requirements and
Test Methods, Technical Corrigendum.
Intended Use of the Device:
The condom has the same intended use as the predicate condom. The condom is
used for contraception and for prophylactic purposes (to help reduce the risk of
pregnancy and the transmission of sexually transmitted diseases, STDs).
Technological Characteristics:
The basic technological characteristics of the LifeStyles condom are the same as
the predicate condom. The LifeStyles condom and the predicate condom are of
the same basic design; both are straight-walled, nipple-ended, lubricated condoms
with an integral ring at the open end. The condom design conforms to national
3
and international standards: ASTM D3492 Standard Specification for Rubber
Contraceptives (Male Condoms) and ISO 4074:2002Cor. 1:3002(E): Natural Latex
Rubber Condoms - Requirements and Test Methods, Technical Corrigendum.
Conclusion:
Based on intended use and technological characteristics, the LifeStyles condom is
substantially equivalent to the predicate device; the Suretex Ltd. Latex Condom
with Silicone Oil Lubricant (K941258).
4 3~~~i3
DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service
Food and Drug Administration
g200Corporate Boulevard
Rockville MD 20850
MAR - 6 2008
Mr. Lon McIlvain
Vice President, Regulatory Affairs Global
Ansell Healthcare Products LLC
1635 Industrial Road
DOTHAN AL 36303
Re: K070800
Trade/Device Name: LifeStyles Lubricated Polyisoprene Latex Male Condom
Regulation Number: 21 CFR §884.5300
Regulation Name: Condom
Regulatory Class: II
Product Code: MOL
Dated: January 25, 2008
Received: January 28, 2008
Dear Mr. Mcllvain:
We have reviewed your Section 5 10(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 premarketoapproval 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, libeling, and prohibitions against misbranding and
adulterati0/n.
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, FDK
may publish further announcements concerning yourdevice in,the Federal Register.
Page 2
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 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please
contact the Center for Devices and Radiological Health's (CDRH's) 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"
(21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's
Office of Surveillance and Biometric's (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
Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or
(240) 276-3150 or at its Internet address http://www.fda. gov/cdrh/industry/support/index.html.
Sincerely yours,
Nancy C. Brogdon
Director, Division of Reproductive,
Abdominal, and Radiological Devices
Office of Device Evaluation
Center for Devices and Radiological Health
Enclosure
INDICATIONS FOR USE
510(k) Number: <u2 g
Device Name: LifeStyles Lubricated Polyisoprene Latex Male Condom
Indications for Use:
The LifeStyles Lubricated Polyisoprene Latex Male Condom is used for
contraception and for prophylactic purposes (to help reduce the risk of pregnancy
and the transmission of sexually transmitted diseases, STDs).
3~~~~~~~~~~~¾
Prescription Use _____ AND/OR Over-The-Counter Use _______
(Per 21 CFR §801.109)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division SignOf
Division of Rerdcive, Abdominal,
and Radiological Devices og'
~o
510(k) Numbr_____________
