(371 days)
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.)
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 <24 hours and contact the mucosal membrane. They are for home use.
aoni Natural Rubber Latex Condom include four types as following:
[Smooth]: aoni Natural rubber latex condom [Smooth] are straight walled bulbous ended with smooth surface, having a nominal length of 180mm, a nominal width of 52mm/54mm/55mm, a nominal thickness of 0.036-0.080mm, Natural color
[Dotted]: aoni Natural rubber latex condom [Dotted] are straight walled bulbous ended with Dotted surface, having a nominal length of 180mm, a nominal width of 52mm, a nominal thickness of 0.036-0.080mm, Natural color.
[Combined: (smooth+girdling)]: aoni Natural rubber latex condom [Combined: (smooth+girdling)] are girdling walled bulbous ended with smooth surface, having a nominal length of 180mm, a nominal width of 52mm, a nominal thickness of 0.036-0.080mm, Natural color.
[Combined: (dotted+girdling)]: aoni Natural rubber latex condom [Combined: (dotted+girdling)] are girdling walled bulbous ended with dotted surface, having a nominal length of 180mm, a nominal width of 52mm, a nominal thickness of 0.036-0.080mm, Natural color.
Acceptance Criteria and Device Performance for aoni Natural Rubber Latex Condom
This document summarizes the acceptance criteria and reported device performance for the "aoni Natural Rubber Latex Condom," as described in the provided 510(k) summary (K153016).
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the aoni Natural Rubber Latex Condom are based on recognized international and national standards for rubber contraceptives and biocompatibility. The reported device performance indicates that the product met these specifications.
Table 1: Acceptance Criteria and Reported Device Performance
| Parameter / Test | Acceptance Criteria | Reported Device Performance | Standard(s) Applied |
|---|---|---|---|
| Physical Performance Tests | |||
| Water Leakage (Freedom from Holes) | Met specifications of ISO 4074:2002 and ASTM D3492-14 | "met the specifications" | ISO 4074:2002, ASTM D3492-14 |
| Burst Volume and Pressure | Met specifications of ISO 4074:2002 and ASTM D3492-14 | "met the specifications" | ISO 4074:2002, ASTM D3492-14 |
| Dimensions (Length, Width, Thickness) | Within specified ranges (e.g., Nominal Length 180mm, Width 52/54/55mm, Thickness 0.036-0.080mm) | Conformed to nominal dimensions and thickness ranges | ISO 4074:2002, ASTM D3492-14 |
| Biocompatibility Tests | |||
| Cytotoxicity | Met acceptance criteria of ISO 10993-5:2009 | "passed each biocompatibility test" | ISO 10993-5:2009 |
| Skin Irritation | Met acceptance criteria of ISO 10993-10:2010 | "passed each biocompatibility test" | ISO 10993-10:2010 |
| Vaginal Irritation | Met acceptance criteria of ISO 10993-10:2010 | "passed each biocompatibility test" | ISO 10993-10:2010 |
| Sensitization | Met acceptance criteria of ISO 10993-10:2010 | "passed each biocompatibility test" | ISO 10993-10:2010 |
| Acute Systemic Toxicity | Met acceptance criteria of ISO 10993-11:2006 | "passed each biocompatibility test" | ISO 10993-11:2006 |
| Shelf Life | 5 years (60 months) | "has a five years (60 month) shelf life based on the results of real time storage and testing" | 21 CFR 801.435, ISO 4074:2012 (Note: Document specifies 2012, while performance tests mention 2002 version for ISO 4074) |
Note on Standards: The document refers to ISO 4074:2002 for performance testing and ISO 4074:2012 for shelf life. Both are relevant versions of the standard for natural rubber latex condoms.
2. Sample Size Used for the Test Set and Data Provenance
The provided document describes non-clinical testing for performance and biocompatibility. It does not refer to a "test set" in the context of clinical studies with human subjects.
- Sample Size for performance and biocompatibility testing: The specific sample sizes for each non-clinical test (e.g., number of condoms for burst testing, number of animals for toxicity tests) are not explicitly stated in the provided 510(k) summary. The summary only broadly states that "Each variant of aoni Natural Rubber Latex Condom was tested".
- Data Provenance: The testing was conducted by Guangzhou Daming United Rubber Products Ltd. or its contracted laboratories. The information does not specify the country of origin for the data for individual tests beyond the manufacturer's location in Guangzhou, China. All testing appears to be retrospective (i.e., conducted on finished products to demonstrate compliance with standards) rather than prospective clinical trials.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This section is not applicable as the evaluation described is for ex-vivo device performance and biocompatibility testing against established standards, not a clinical study requiring expert assessment of "ground truth" for a test set (e.g., diagnosis of disease). The "ground truth" in this context is defined by the technical specifications and requirements outlined in the referenced ISO and ASTM standards.
4. Adjudication Method for the Test Set
This section is not applicable. The evaluation described involves objective physical and chemical testing against pre-defined performance criteria in established standards, not interpretation by human adjudicators.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
An MRMC comparative effectiveness study was not performed as this device (a condom) is not a diagnostic device that relies on human interpretation for an outcome. The evaluation is based on objective physical and chemical tests.
6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)
This section is not applicable. The device is a physical medical device (condom), not an algorithm or AI-driven system. Therefore, standalone algorithm performance is not relevant.
7. Type of Ground Truth Used
The "ground truth" for demonstrating device compliance is defined by:
- Performance Specifications: Quantitative and qualitative requirements outlined in ISO 4074: Natural Rubber Latex Condoms – Requirements and Test Methods and ASTM D3492-14 Standard Specification for Rubber Contraceptives (Male Condom). These standards define acceptable ranges for parameters like burst volume and pressure, freedom from holes, and dimensions.
- Biocompatibility Standards: Criteria for various biological responses (cytotoxicity, irritation, sensitization, systemic toxicity) outlined in ISO 10993-1: Biological Evaluation of Medical Devices - Part 1, and its sub-parts (e.g., ISO 10993-5, ISO 10993-10, ISO 10993-11).
In essence, the ground truth is derived from established scientific and engineering standards and accepted laboratory test methods.
8. Sample Size for the Training Set
This section is not applicable. As a physical device, there is no "training set" in the context of machine learning or AI models. The manufacturing process is validated (and products routinely tested) to ensure consistent quality and adherence to specifications.
9. How the Ground Truth for the Training Set Was Established
This section is not applicable for the reasons stated in point 8. The "ground truth" for manufacturing a condom to meet specifications is established through the development and validation of manufacturing processes to consistently produce a product that passes the non-clinical tests detailed above.
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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
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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 <24 hours and contact the mucosal membrane. They are for home use.
aoni Natural Rubber Latex Condom include four types as following:
[Smooth]: aoni Natural rubber latex condom [Smooth] are straight walled bulbous ended with smooth surface, having a nominal length of 180mm, a nominal width of 52mm/54mm/55mm, a nominal thickness of 0.036-0.080mm, Natural color[Dotted]: aoni Natural rubber latex condom [Dotted] are straight walled bulbous ended with Dotted surface, having a nominal length of 180mm, a nominal width of 52mm, a nominal thickness of 0.036-0.080mm, Natural color.
[Combined: (smooth+girdling)]: aoni Natural rubber latex condom [Combined: (smooth+girdling)] are girdling walled bulbous ended with smooth surface, having a nominal length of 180mm, a nominal width of 52mm, a nominal thickness of 0.036-0.080mm, Natural color.
[Combined: (dotted+girdling)]: aoni Natural rubber latex condom
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| [Combined: (dotted+girdling)] are girdling walled bulbous ended with dotted surface, having a nominal length of 180mm, a nominal width of 52mm, a nominal thickness of 0.036-0.080mm, Natural color.This condom has the same intended use as the predicate condom.The condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted infections.) | |
|---|---|
| Intended Use of the Device: |
Technological Characteristics
The condom is substantially equivalent to the predicate device, the Latex lubricated condom (K120394).
The indication for use statement for aoni Natural Rubber Latex Condom is consistent with the Latex lubricated condom (K120394), additionally, the design is in conformance with ASTM Latex Condom Standard D3492, and that the condom is made of natural rubber latex. The only differences between our condom and predicate condom (K120394) is condom dimensions, type of lubricant, and fragrance.
Predicate Product Comparison
| Parameters | Guangzhou Daming United RubberProducts Ltd. | Ansell Healthcare Product, LLC |
|---|---|---|
| 510(k) Number | - | K120394 |
| Intended Use | aoni Natural Rubber Latex Condom isused for contraception and forprophylactic purposes (to help preventpregnancy and the transmission ofsexually transmittedinfections.) | LifeStyles Zero Condoms is used forcontraception and for prophylacticpurposes (to help prevent pregnancyand the transmission of sexuallytransmitted diseases.) |
| Material | Natural rubber latex | Natural rubber latex |
| Design | Straight-walled, smooth, cylindrical,reservoir | Straight-walled, cylindrical, reservoir |
| Nominal Length | 180mm | 185mm |
| Nominal width | 52mm , 54mm , 55mm | 51mm |
| Nominalthickness | 0.036-0.080mm | 0.04mm |
| Color | Natural | Natural |
| Scented | Yes | No |
| Lubricant | Water-based lubricant | Silicone (silicone oil) |
| Biocompatibility | ISO 10993Acceptance criteria met | ISO 10993Acceptance criteria met |
| Table 2 Predicate Product Comparisons - aoni Natural rubber latex condom [Dotted] | ||
| Parameters | Guangzhou Daming United RubberProducts Ltd. | Ansell Healthcare Product, LLC |
Table 1 Predicate Product Comparisons - aoni Natural rubber latex condom [Smooth]
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| 510(k) Number | - | K120394 |
|---|---|---|
| Intended Use | aoni Natural Rubber Latex Condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmittedinfections.) | LifeStyles Zero Condoms is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases.) |
| Material | Natural rubber latex | Natural rubber latex |
| Design | Straight-walled, dotted, cylindrical, reservoir | Straight-walled, cylindrical, reservoir |
| Nominal Length | 180mm | 185mm |
| Nominal width | 52mm | 51mm |
| Nominal thickness | 0.036-0.080mm | 0.04mm |
| Color | Natural | Natural |
| Scented | Yes | No |
| Lubricant | Water-based lubricant | Silicone (silicone oil) |
| Biocompatibility | ISO 10993Acceptance criteria met | ISO 10993Acceptance criteria met |
Table 3 Predicate Product Comparisons - aoni Natural rubber latex condom [Combined:
| Parameters | Guangzhou Daming United Rubber Products Ltd. | Ansell Healthcare Product, LLC |
|---|---|---|
| 510(k) Number | - | K120394 |
| Intended Use | aoni Natural Rubber Latex Condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmittedinfections.) | LifeStyles Zero Condoms is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases.) |
| Material | Natural rubber latex | Natural rubber latex |
| Design | Straight-walled with girdling, smooth, reservoir | Straight-walled, cylindrical, reservoir |
| Nominal Length | 180mm | 185mm |
| Nominal width | 52mm | 51mm |
| Nominal thickness | 0.036-0.080mm | 0.04mm |
| Color | Natural | Natural |
| Scented | Yes | No |
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| Lubricant | Water-based lubricant | Silicone (silicone oil) |
|---|---|---|
| Biocompatibility | ISO 10993Acceptance criteria met | ISO 10993Acceptance criteria met |
Table 4 Predicate Product Comparisons - aoni Natural rubber latex condom [Combined: dotted+airdling]
| Parameters | Guangzhou Daming United RubberProducts Ltd. | Ansell Healthcare Product, LLC |
|---|---|---|
| 510(k) Number | - | K120394 |
| Intended Use | aoni Natural Rubber Latex Condom isused for contraception and forprophylactic purposes (to help preventpregnancy and the transmission ofsexually transmittedinfections.) | LifeStyles Zero Condoms is used forcontraception and for prophylacticpurposes (to help prevent pregnancyand the transmission of sexuallytransmitted diseases.) |
| Material | Natural rubber latex | Natural rubber latex |
| Design | Straight-walled with girdling, dotted,reservoir | Straight-walled, cylindrical, reservoir |
| Nominal Length | 180mm | 185mm |
| Nominal width | 52mm | 51mm |
| Nominalthickness | 0.036-0.080mm | 0.04mm |
| Color | Natural | Natural |
| Scented | Yes | No |
| Lubricant | Water-based lubricant | Silicone (silicone oil) |
| Biocompatibility | ISO 10993Acceptance criteria met | ISO 10993Acceptance criteria met |
Non-clinical testing:
Biocompatibility : Biocompatibility testing was performed to evaluate the biocompatibility of the aoni Natural Rubber Latex Condom in accordance with ISO 10993-1:2009, the device passed each biocompatibility test indentified below:
- Cytotoxicity testing in according to ISO 10993-5:2009 -
- Skin irritation testing in according to ISO 10993-10:2010 -
- -Vaginal irritation testing in according to ISO 10993-10:2010
- -Sensitization testing in according to ISO 10993-10:2010
- -Acute systemic toxicity testing in according to ISO 10993-11:2006
Performance testing: Each variant of aoni Natural Rubber Latex Condom was tested and met the specifications of ISO 4074: Natural Rubber Latex Condoms - Requirements and Test Methods, ASTM D3492-14 Standard Specification for Rubber Contraceptives (Male Condom),
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Shelf life:
aoni Natural Rubber Latex Condom has a five years (60 month) shelf life based on the results of real time storage and testing of 21 CFR 801.435 and ISO 4074:2012.
Conclusion:
The aoni Natural Rubber Latex Condom is substantially equivalent to the predicate device in indications for use, materials. Safety and performance testing to ASTM D3492-14 Standard Specifications for Rubber Contraceptives (Male Condoms) and ISO 10993 Biological Evaluation of Medical Devices has concluded that the aoni Natural Rubber Latex Condom are substantially equivalent to the predicate devices (K120394) in term of safety and effectiveness.
§ 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.