One Touch

K181844 · Thai Nippon Rubber Industry Public Company, Ltd. · HIS · Apr 15, 2019 · Obstetrics/Gynecology

Device Facts

• Record ID: K181844
• Device Name: One Touch
• Applicant: Thai Nippon Rubber Industry Public Company, Ltd.
• Product Code: HIS · Obstetrics/Gynecology
• Decision Date: Apr 15, 2019
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 884.5300
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The One Touch male natural rubber latex condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted infections).

Device Story

One Touch is a male natural rubber latex condom; straight-walled design with reservoir tip; silicone lubricated; dusted with corn starch. Used for contraception and prophylaxis against sexually transmitted infections. Device covers penis with closely fitting membrane. Dimensions: 210mm length, 60mm width, 0.07mm thickness. Intended for over-the-counter use by individuals.

Clinical Evidence

Bench testing only. Biocompatibility testing performed per ISO 10993-5 (cytotoxicity), ISO 10993-10 (sensitization and vaginal irritation), and ISO 10993-11 (acute systemic toxicity). Physical testing (airburst) conducted on three lots per ISO 4074:2015 and ASTM D3492:2016. Shelf-life supported by stability testing for five years.

Technological Characteristics

Material: Natural rubber latex. Design: Straight-walled, reservoir tip. Lubricant: Silicone. Dusting agent: Corn starch. Dimensions: 210mm length, 60mm width, 0.07mm thickness. Standards: ASTM D3492:2016, ISO 4074:2015. Biocompatibility: ISO 10993 series.

Indications for Use

Indicated for contraception and prevention of pregnancy and sexually transmitted infections in males.

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

• Thai Nippon Male Latex Condom 56 mm (K081265)

Submission Summary (Full Text)

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# Indications for Use

510(k) Number (if known) K181844

Device Name One Touch

Indications for Use (Describe)

The One Touch male natural rubber latex condom is used for contraception and for prophylactic purposes (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)

X Over-The-Counter Use (21 CFR 801 Subpart C)

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## 510K Summary K181844

| Submitted By: | Thai Nippon Rubber Industry Public Company Ltd<br>1 Charoenrat Road,<br>Thungwatdon Sub-district, Sathon,<br>Bangkok 10120<br>Thailand |
|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Applicant Contact: | Mr. Tossaporn Nilkhamhang<br>Thai Nippon Rubber Industry Public Company Ltd<br>Phone: [phone]<br>Fax: [phone]<br>[e-mail] |
| Correspondent: | Prabhat Garg<br>KUPS International<br>8516 Burning Tree Road<br>Bethesda, MD 20817<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| Date Prepared: | April 12, 2019 |
| Device Trade Name: | One Touch |
| Device Common Name: | Male Natural Rubber Latex Condom |
| Regulation Name: | Condom |
| Regulation Number: | 884.5300 |
| Product Code: | HIS (Condom) |
| Regulatory Class: | Class II |
| Predicate Device: | K081265: Thai Nippon Male Latex Condom 56 mm<br>(nominal width), flared, colorless, silicone lubricated |
| | The predicate device has not been subject to a design-<br>related recall |

### Device Description:

The One Touch condom is made of a natural rubber latex sheath, which completely covers the penis with a closely fitting membrane. The condom is straight-walled with a

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reservoir tip, and is silicone lubricated. Condom dimensions are length 210 ± 10 mm, width 60 ± 2 mm, and thickness 0.07 ± 0.01 mm. The condom is designed to conform to the requirements of ASTM D3492:2016 and ISO 4074:2015.

## Indications for Use:

The One Touch male natural rubber latex condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted infections).

| Characteristic | Subject Device<br>K181844 | Predicate Device<br>K081265 | Comparison |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for<br>Use | The One Touch male<br>natural rubber latex<br>condom is used for<br>contraception and for<br>prophylactic purposes<br>(to help prevent<br>pregnancy and the<br>transmission of<br>sexually transmitted<br>infections). | The Thai Nippon<br>Male Latex Condom<br>is used for<br>contraception and for<br>prophylactic<br>purposes (to help<br>prevent pregnancy<br>and transmission of<br>sexually transmitted<br>diseases). | Same: Although there<br>are minor wording<br>differences, the<br>indications for use and<br>intended uses are the<br>same. |
| Condom<br>Material | Natural Rubber Latex | Same | Same |
| Design | Straight-walled,<br>smooth, reservoir tip | Straight-walled,<br>flared at closed end,<br>reservoir tip | Different: The subject<br>device is a standard<br>straight-walled<br>condom, while the<br>predicate has a flared<br>closed end. This<br>difference does not<br>raise different<br>questions of Safety and<br>Effectiveness (S&E). |
| Colors | None | None | Same |
| Lubricant | Silicone lubricant | Same | Same |
| Dusting Agent | Corn Starch | Corn Starch | Same |
| Nominal<br>Length | 210 mm ± 10mm | 200 mm | Different: The subject<br>device is slightly<br>longer than the<br>predicate device.<br>However, this<br>difference does not<br>raise different<br>questions of S&E. The<br>length is within the |
| | | | range specified in<br>ASTM D3492-16. |
| Nominal<br>Width | $60 \text{ mm } \pm 2\text{mm}$ | 56 mm | Different: The subject<br>device is slightly wider<br>than the predicate<br>device. However, this<br>difference does not<br>raise different<br>questions of S&E. The<br>width is within the<br>range specified in<br>ASTM D3492-16 and<br>ISO 4074:2015. |
| Nominal<br>Thickness | $0.07 \pm 0.01 \text{ mm}$ | 0.07 mm | Same |

## Substantial Equivalence Comparison

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As shown above, there are minor differences in the wording of the subject and predicate device indications statements; however, the intended uses are the same. Regarding technological characteristics, the subject and predicate devices have similarities in condom material, lubricant type, and lack of colorants. However, differences do exist as described in the table above (e.g., dimensions, general design, etc.). The differences identified do not raise different questions of safety and effectiveness as compared to the predicate device as stated in the table.

## Summary of Performance Testing:

- Biocompatibility testing as follows:
- o Cytotoxicity testing per ISO 10993-5:2009
- Guinea pig maximization sensitization testing per ISO 10993-10:2010 o
- Vaginal irritation testing per ISO 10993-10:2010 o
- o Acute systemic toxicity testing for ISO 10993-11:2006
- Physical Testing Data: Three lots of devices were tested at baseline and met airburst specifications of ISO 4074:2015 - Natural rubber latex male condoms -Requirements and test methods and ASTM D3492:2016 - Standard Specification for Rubber Contraceptives (Male Condoms).
- Shelf Life: Stability testing to support a shelf-life of five years per the ● requirements of 21 CFR §801.435.

### Conclusion:

Based on the results of the testing and safety data described above, the One Touch male natural rubber latex condom is as safe and effective as the predicate device. The performance data support a determination of substantial equivalence.

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April 15, 2019

Thai Nippon Rubber Industry Public Company Ltd. % Prabhat Garg Registered Agent for Thai Nippon Rubber Industry Public Company Ltd. KUPS International 8516 Burning Tree Road Bethesda, MD 20817

Re: K181844 Trade/Device Name: One Touch Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: HIS Dated: March 6, 2019 Received: March 15, 2019

Dear Prabhat Garg:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see

https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

for 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