The LifeStyles® Zero® condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases).

Device Description

This condom is made of a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. The device is a straight-walled, cylindrical, lubricated condom with a reservoir tip. The device is designed to conform to the specifications of ASTM D3492, Standard Specification for Rubber Contraceptives (Male Condoms) and is provided in a foil package.

AI/ML Overview

The provided text is a 510(k) summary for a medical device (condom) seeking substantial equivalence to a predicate device. It does not describe an AI/ML powered device, and therefore the information requested in the prompt (acceptance criteria, study details, human reader improvement, standalone performance, ground truth, training set size, etc.) is not present in the document.

The document focuses on comparing the new device's technical characteristics with a predicate device to demonstrate substantial equivalence, rather than providing performance metrics against specific acceptance criteria for an AI/ML algorithm.

Therefore, I cannot fulfill your request using the provided input.

Summary

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K120394
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II. 510(k) SUMMARY

Applicant:

Ansell Healthcare Products, LLC 1635 Industrial Road Dothan, AL 36303 USA Phone: (334) 615-2563 Fax: (334) 615-2574

Cynthia Ingram, Regulatory Affairs Manager, Americas Contact Person:

February 02, 2012 Date Prepared:

LifeStyles® Zero® Lubricated Latex Condom Proprietary Name:

Latex Condom Common Name:

Condom (21 CFR 884.5300; Product Code HIS) Classification

Name:

Billy Boy Male Latex Condoms (K103119) Predicate Device(s):

Device Description:

Intendications for Use:

This latex condom has the same intended use as the predicate condom. LifeStyles® Zero® condom is used for contraceptive and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases).

Technological Characteristics:

Feemforogroum and the predicate device identified above are made from natural rubber latex, with designs that are biocompatible and in conformance with the requirements of the ASTM D 3492-08 condom standard. Both are straight-walled, requirements or condoms, with a reservoir tip, provided in a foil package. This cymidned, fubricated oonaoms, waate device is scented. The absence of scent has no material impact on safety and effectiveness.

The table below compares specific technological characteristics of the condom to the predicate:

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K120394
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Ansell Healthcare Products, LLC Attachment Page 11

II. 510(k) SUMMARY, Continued

	LifeStyles® Zero® LubricatedLatex Condom	Billy Boy Male LatexCondoms
Material	Natural rubber latex	Natural rubber latex
Condom Film	Compounded natural rubberlatex formulation	Compounded natural rubberlatex formulation
Design	Straight-walled, cylindrical,reservoir tip	Straight-walled, cylindrical,reservoir tip
Lubricant	Silicone (silicone oil)	Silicone (silicone oil)
Primary Package	Foil	Foil
Length	185 mm	185 mm
Width	51 mm	52 mm
Thickness	0.04 mm	0.04 to 0.08 mm
Color	Natural	Natural
Scented	No	Yes

Summary:

This condom has the same intended use and basic technological characteristics as the predicate device. This condom is as safe and effective as the predicate device.

. . . .

・

。

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K120394
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II. 510(k) SUMMARY, Continued

	LifeStyles® Zero® LubricatedLatex Condom	Billy Boy Male LatexCondoms
Material	Natural rubber latex	Natural rubber latex
Condom Film	Compounded natural rubberlatex formulation	Compounded natural rubberlatex formulation
Design	Straight-walled, cylindrical,reservoir tip	Straight-walled, cylindrical,reservoir tip
Lubricant	Silicone (silicone oil)	Silicone (silicone oil)
Primary Package	Foil	Foil
Length	185 mm	185 mm
Width	51 mm	52 mm
Thickness	0.04 mm	0.04 to 0.08 mm
Color	Natural	Natural
Scented	No	Yes

Summary:

This condom has the same intended use and basic technological characteristics as the predicate device. This condom is as safe and effective as the predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three heads, representing the department's commitment to health, human services, and science. The eagle is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement. The logo is black and white.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Ansell Healthcare Products, LLC % Ms. Donna Di Gangi Principal DiGangi Consulting 4 Los Verdes Drive SAN LUIS OBISPO CA 93401

MAY - 8 2012

K120394 Re:

Trade/Device Name: LifeStyles® Zero® Lubricated Latex Condom Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: HIS Dated: February 2, 2012 Received: February 8, 2012

Dear Ms. Gangi:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical

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Page 2-

device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Benjamin R. Fisher, Ph.D.

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Ansell Healthcare Products, LLC

Indications for Use

120394

510(k) Number (if known):

Device Name: LifeStyles® Zero® Lubricated Latex Condom

Indications for Use: The LifeStyles® Zero® condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases).

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use _ X (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)

Richard Renner

(Division Sign-Off) Division of Reproductive, Gastro-Renal, and Urological Devices 21394 510(k) Number

Regulation Number and Section

§ 884.5300 Condom.

(a)
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.(b)
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.