(371 days)
Not Found
No
The device description and intended use clearly describe a physical product (condom) made of natural rubber latex, with no mention of software, data processing, or any technology that would involve AI or ML.
No.
The intended use of the device is for contraception and prophylactic purposes (to help prevent pregnancy and transmission of sexually transmitted infections), not for treating a disease or condition.
No
Explanation: The device is a condom, intended for contraception and prevention of sexually transmitted infections. Its function is prophylactic, not diagnostic; it does not identify or detect a disease or condition.
No
The device description clearly states it is a "natural rubber latex sheath" and describes physical characteristics like length, width, and thickness, indicating it is a physical hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside of the body.
- Condom Function: The aoni Natural Rubber Latex Condom is a barrier device used on the body (specifically, on the penis) for contraception and preventing the transmission of STIs. It does not perform any diagnostic tests on bodily samples.
The provided information clearly describes a physical barrier device for direct use on the body, not a device for analyzing samples in a laboratory setting.
N/A
Intended Use / Indications for Use
The Condom is used for contraception and for prophylactic purpose ( to help prevent pregnancy and the transmission of sexually transmitted infections.)
Product codes (comma separated list FDA assigned to the subject device)
HIS
Device Description
aoni Natural Rubber Latex Condom is made of a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. These condoms conform to ISO 4074:2002 Natural Rubber Latex Condoms – Requirements and Test Methods, ASTM D3492-14 Standard Specification for Rubber Contraceptives (Male Condom), and ISO 10993-1 Biological Evaluation of Medical Devices - Part 1(2009). These condoms have repeated contact potential for a duration of
§ 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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol of three human profiles facing right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 20, 2016
Guangzhou Daming United Rubber Products Ltd. Yongbing Xie Chairman Secretary No. 1 Daming Street, Port Industrial Zone Huada District Guangzhou, Guangdong 510802 CHINA
Re: K153016 Trade/Device Name: aoni Natural Rubber Latex Condom Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Regulatory Class: Class II Product Code: HIS Dated: August 17, 2016 Received: September 21, 2016
Dear Yongbing Xie:
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 mav 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
1
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical 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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Benjamin R. Fisher -S
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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K153016
Device Name
aoni Natural Rubber Latex Condom [Smooth/Dotted/Combined]
Indications for Use (Describe)
aoni Natural Rubber Latex Condom [Smooth/Dotted/Combined]
a) Smooth 52mm/54mm/55mm natural
b) Dotted 52mm natural
c) Combined [smooth+girdling] 52mm natural
d) Combined [dotted+girdling] 52mm natural
The Condom is used for contraception and for prophylactic purpose ( to help prevent pregnancy and the transmission of sexually transmitted infections.)
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) SUMMARY K153016
Submitted by:
Contact Person: Date Prepared: Proprietary Name: Common Name: Classification Name: Product Code: Classification: Predicate Device:
Description of the Device:
Guangzhou Daming United Rubber Products Ltd. NO.1 Daming Street. Port Industrial Zone Huadu District Guangzhou, Guangdong Province 510802 China Phone: 086-020-22680888-8296 E-mail: dm500@ausny.com Yongbing Xie 20 October, 2016 aoni Natural Rubber Latex Condom Condom Condom (21 CFR §884.5300) HIS - Condom Class II LifeStyles Zero Lubricated Latex Condom 510(k) # K120394 Predicate has not been subject to a design-related recall aoni Natural Rubber Latex Condom is made of a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. These condoms conform to ISO 4074:2002 Natural Rubber Latex Condoms – Requirements and Test Methods, ASTM D3492-14 Standard Specification for Rubber Contraceptives (Male Condom), and ISO 10993-1 Biological Evaluation of Medical Devices - Part 1(2009). These condoms have repeated contact potential for a duration of