aoni Natural Rubber Latex Condom

K153016 · Guangzhou Daming United Rubber Products , Ltd. · HIS · Oct 20, 2016 · Obstetrics/Gynecology

Device Facts

• Record ID: K153016
• Device Name: aoni Natural Rubber Latex Condom
• Applicant: Guangzhou Daming United Rubber Products , Ltd.
• Product Code: HIS · Obstetrics/Gynecology
• Decision Date: Oct 20, 2016
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 884.5300
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Condom is used for contraception and for prophylactic purpose ( to help prevent pregnancy and the transmission of sexually transmitted infections.)

Device Story

aoni Natural Rubber Latex Condom is a natural rubber latex sheath designed to cover the penis. Device variants include smooth, dotted, and combined (girdling) surfaces with varying widths (52mm, 54mm, 55mm). Intended for home use, the device acts as a physical barrier to prevent pregnancy and the transmission of sexually transmitted infections. It is a single-use, disposable product. The device is manufactured to conform to ISO 4074 and ASTM D3492 standards. It provides a mechanical barrier; no electronic or software components are involved.

Clinical Evidence

Bench testing only. Biocompatibility testing performed per ISO 10993-1:2009, including cytotoxicity (ISO 10993-5), skin/vaginal irritation (ISO 10993-10), sensitization (ISO 10993-10), and acute systemic toxicity (ISO 10993-11). Performance testing conducted per ISO 4074 and ASTM D3492-14. Shelf life validated for 60 months.

Technological Characteristics

Material: Natural rubber latex. Design: Straight-walled or girdling, bulbous-ended, reservoir tip. Dimensions: 180mm length, 52-55mm width, 0.036-0.080mm thickness. Lubricant: Water-based. Standards: ISO 4074:2002, ASTM D3492-14, ISO 10993-1:2009. Biocompatibility: Passed cytotoxicity, irritation, sensitization, and systemic toxicity tests.

Indications for Use

Indicated for use by individuals for contraception and the prevention of pregnancy and sexually transmitted infections.

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.

Predicate Devices

• LifeStyles Zero Lubricated Latex Condom (K120394)

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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: [phone]-8296 E-mail: [e-mail] 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.<br>This condom has the same intended use as the predicate condom.<br>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 Rubber<br>Products Ltd. | Ansell Healthcare Product, LLC |
|-----------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | - | K120394 |
| Intended Use | aoni Natural Rubber Latex Condom is<br>used for contraception and for<br>prophylactic purposes (to help prevent<br>pregnancy and the transmission of<br>sexually transmittedinfections.) | LifeStyles Zero Condoms is used for<br>contraception and for prophylactic<br>purposes (to help prevent pregnancy<br>and the transmission of sexually<br>transmitted diseases.) |
| Material | Natural rubber latex | Natural rubber latex |
| Design | Straight-walled, smooth, cylindrical,<br>reservoir | Straight-walled, cylindrical, reservoir |
| Nominal Length | 180mm | 185mm |
| Nominal width | 52mm , 54mm , 55mm | 51mm |
| Nominal<br>thickness | 0.036-0.080mm | 0.04mm |
| Color | Natural | Natural |
| Scented | Yes | No |
| Lubricant | Water-based lubricant | Silicone (silicone oil) |
| Biocompatibility | ISO 10993<br>Acceptance criteria met | ISO 10993<br>Acceptance criteria met |
| Table 2 Predicate Product Comparisons - aoni Natural rubber latex condom [Dotted] | | |
| Parameters | Guangzhou Daming United Rubber<br>Products 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 10993<br>Acceptance criteria met | ISO 10993<br>Acceptance 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 10993<br>Acceptance criteria met | ISO 10993<br>Acceptance criteria met |

Table 4 Predicate Product Comparisons - aoni Natural rubber latex condom [Combined: dotted+airdling]

| Parameters | Guangzhou Daming United Rubber<br>Products Ltd. | Ansell Healthcare Product, LLC |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | - | K120394 |
| Intended Use | aoni Natural Rubber Latex Condom is<br>used for contraception and for<br>prophylactic purposes (to help prevent<br>pregnancy and the transmission of<br>sexually transmittedinfections.) | LifeStyles Zero Condoms is used for<br>contraception and for prophylactic<br>purposes (to help prevent pregnancy<br>and the transmission of sexually<br>transmitted diseases.) |
| Material | Natural rubber latex | Natural rubber latex |
| Design | Straight-walled with girdling, dotted,<br>reservoir | Straight-walled, cylindrical, reservoir |
| Nominal Length | 180mm | 185mm |
| Nominal width | 52mm | 51mm |
| Nominal<br>thickness | 0.036-0.080mm | 0.04mm |
| Color | Natural | Natural |
| Scented | Yes | No |
| Lubricant | Water-based lubricant | Silicone (silicone oil) |
| Biocompatibility | ISO 10993<br>Acceptance criteria met | ISO 10993<br>Acceptance 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.