Microthin Natural Rubber Latex Condom

K213921 · Suretex Limited · HIS · Apr 28, 2022 · Obstetrics/Gynecology

Device Facts

• Record ID: K213921
• Device Name: Microthin Natural Rubber Latex Condom
• Applicant: Suretex Limited
• Product Code: HIS · Obstetrics/Gynecology
• Decision Date: Apr 28, 2022
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 884.5300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Microthin Natural Rubber Latex Condom is used for contraception and prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted infections).

Device Story

Male contraceptive device; natural rubber latex membrane sheath; straight-walled; smooth surface; reservoir tip; lubricated with silicone oil. Used by individuals for contraception and STI prevention. Device covers penis; provides physical barrier. Benefits include pregnancy prevention and reduced transmission risk of STIs.

Clinical Evidence

Bench testing only. Physical testing (airburst) on three lots met ASTM D3492-16 and ISO 4074:2015 standards. Shelf-life testing (5 years) met 21 CFR 801.435 requirements. Biocompatibility testing performed per ISO 10993-1, including cytotoxicity (ISO 10993-5), sensitization (ISO 10993-10), irritation (ISO 10993-10), and acute systemic toxicity (ISO 10993-11).

Technological Characteristics

Material: Natural rubber latex. Dimensions: 170mm length, 52mm width, 0.035mm thickness. Lubricant: Silicone oil. Standards: ASTM D3492-16, ISO 4074:2015. Shelf-life: 5 years. No colorants or flavors.

Indications for Use

Indicated for contraception and prevention of pregnancy and sexually transmitted infections in individuals using male condoms.

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

• Extremely Thin 003, ZERO ZERO THREE (K192669)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.

April 28, 2022

Suretex Limited % Carole C. Carey Senior Consultant C3-Carey Consultants, LLC 9451 Ellsworth Court Fulton, MD 20759

K213921 Re:

> Trade/Device Name: Microthin Natural Rubber Latex Condom Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: HIS Dated: March 21, 2022 Received: March 28, 2022

Dear Carole C. Carey:

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/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

For Monica D. Garcia, Ph.D. Assistant Director DHT3B: Division of Reproductive, Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K213921

Device Name

Microthin Natural Rubber Latex Condom

Indications for Use (Describe)

The Microthin Natural Rubber Latex Condom is used for contraception and 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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Image /page/3/Picture/0 description: The image shows the logo for LifeStyles. The logo consists of a shield with a gradient of colors ranging from yellow to orange to red. To the right of the shield is the word "LifeStyles" in a dark blue, sans-serif font. Below the word "LifeStyles" is the phrase "SINCE 1905" in a smaller, sans-serif font.

# 510(k) Summary - K213921

## Submitter:

Suretex Limited 31/1 Moo 4, Suratthani-Thakuapha Road Tambon Khao Hua Kwai, Amphur Phunphin Suratthani 84130 THAILAND

# Contact Person:

KC Nguyen Vice President, R&D, QA and RA Phone: [phone] Fax: [phone] Email: [e-mail]

### Date Prepared:

April 26, 2022

### Device Name:

Trade Name: Common Name: Regulation Name: Regulation Number: Device Class: Product Code:

Microthin Natural Rubber Latex Condom Male Natural Rubber Latex Condom Condom 21 CFR 884.5300 Class II HIS (Condom)

### Predicate Device:

K192669, Extremely Thin 003, ZERO ZERO THREE (Okamoto U.S.A, Inc.)

The predicate device has not been subject to a design-related recall.

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Image /page/4/Picture/0 description: The image contains the logo for LifeStyles. The logo consists of a shield-shaped emblem on the left and the word "LifeStyles" in blue on the right. Below the word "LifeStyles" is the phrase "SINCE 1905" in a smaller font. The shield emblem has a gradient of colors, including yellow, orange, red, and pink.

# Device Description:

The Microthin Natural Rubber Latex Condom is a male contraceptive made of natural rubber latex that completely covers the penis with a closely fitted membrane sheath. The condom is provided lubricated with silicone oil. The condom is straight-walled, with a smooth surface and a reservoir (nipple end) at the closed end to contain semen. The condom dimensions are length 170mm ± 10mm, width 52 ± 2mm, and thickness 0.035mm ± 0.005mm. The condom conforms to the recognized standards ASTM D3492-16 Standard Specification for Rubber Contraceptives (male condoms) and ISO 4074:2015 Natural Rubber Latex Condoms - Requirements and test methods. The condom has a 5-year shelf-life.

### Indications for Use:

The Microthin Natural Rubber Latex Condom is used for contraception and prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted infections).

#### Comparison of Intended Use and Technological Characteristics:

The table below compares the intended use and technological characteristics of the subject and predicate devices:

| | Subject Device<br>K213921 | Predicate Device<br>K192669 | Comparison |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications<br>for Use | The Microthin Natural<br>Rubber Latex Condom<br>is used for<br>contraception and<br>prophylactic purposes<br>(to help prevent<br>pregnancy and the<br>transmission of<br>sexually transmitted<br>infections). | The condom is used for<br>contraception and for<br>prophylactic purposes<br>(preventing<br>transmission of<br>sexually transmitted<br>infections). | The subject and<br>predicate<br>indications for<br>use are not<br>identical, but<br>both have the<br>same intended<br>use (i.e., to<br>prevent<br>pregnancy and<br>transmission of<br>sexually<br>transmitted<br>infections). |
| Condom<br>Material | Natural Rubber Latex | Natural Rubber Latex | Same |

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Image /page/5/Picture/0 description: The image contains the logo for Lifestyles. On the left is a shield with a gradient of yellow, orange, and red. To the right of the shield is the word "LifeStyles" in a dark blue font, with the words "SINCE 1905" in a smaller font below the word "LifeStyles".

| Nominal<br>Width | $52 \pm 2$ mm | $53.2 \pm 2$ mm | Different |
|-------------------------------|------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| Nominal<br>Length | $170 \pm 10$ mm | $180 \pm 10$ mm | Different |
| Nominal<br>Thickness | $0.035 \pm 0.005$ | 30 mm from closed end:<br>$0.039 \pm 0.0013$<br>90 mm from closed end:<br>$0.039 \pm 0.001$<br>150 mm from closed<br>end: $0.039 \pm 0.001$ | Different |
| Lubricant | Silicone | Silicone | Same |
| Color<br>Additives | No color | No color | Same |
| Flavor<br>Additives | No flavor | No flavor | Same |
| Shape | Straight-walled<br>Reservoir-ended | Straight-walled<br>Reservoir-ended | Same |
| Texture | Smooth Surface | Smooth Surface | Same |
| Bursting<br>Pressure<br>(kPa) | Minimum of 1 kPa | $1.42 \pm 0.10$ | Different |
| Bursting<br>Volume<br>(dm3) | Minimum of 18 L | $35.4 \pm 3.83$ | Different |
| Shelf-life | 5 years | 5 years | Same |

As shown in the table above, the subject and predicate devices do not have identical indications for use statements; however, they do have the same intended use (i.e., to prevent pregnancy and transmission of sexually transmitted infections).

The technological characteristics of the subject and predicate device are similar in that they are natural rubber latex-based, do not contain colorants or flavors, have the same shape and texture, and have the same shelf-life. Differences between the subject and predicate device include dimensions of the condoms (e.g., width, length, and thickness) and burst specifications. These differences in technological characteristics do not raise different questions of safety and effectiveness.

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Image /page/6/Picture/0 description: The image shows the logo for Lifestyles. The logo consists of a shield on the left and the word "LifeStyles" on the right. The shield is red, orange, and yellow. The word "LifeStyles" is blue, and below it is the text "SINCE 1905".

## Summary of Non-Clinical Performance Testing:

The following testing has been performed to support substantial equivalence to the predicate device:

#### Physical Testing

Three lots of the subject device were tested at baseline and met the airburst specifications of ASTM D3492-16 Standard Specification for Rubber Contraceptives (male condoms) and ISO 4074:2015 Natural Rubber Latex Condoms – Requirements and test methods.

#### Shelf-Life Testing

Shelf-life testing was conducted to support a shelf-life of five years per the requirements of 21 CFR §801.435. All samples met the predefined acceptance criteria.

#### Biocompatibility Testing

Biocompatibility testing was conducted in accordance with the 2020 FDA quidance document "Use of International Standard ISO 10993-1, Biological Evaluation of Medical Devices – Part 1: Evaluation and testing within a risk management process." Testing included the following assessments:

- Cytotoxicity (ISO 10993-5:2009) ●
- Sensitization (ISO 10993-10:2010) ●
- Irritation (ISO 10993-10:2010) ●
- Acute systemic toxicity (ISO 10993-11:2017) ●

The device was demonstrated to be biocompatible.

#### Conclusion:

The results of the performance testing described above demonstrate that the Microthin Natural Rubber Latex Condom is as safe and effective as the predicate device and supports a determination of substantial equivalence.