LifeStyles NRL Textured Condom

K232279 · Suretex Limited · HIS · Oct 5, 2023 · Obstetrics/Gynecology

Device Facts

• Record ID: K232279
• Device Name: LifeStyles NRL Textured Condom
• Applicant: Suretex Limited
• Product Code: HIS · Obstetrics/Gynecology
• Decision Date: Oct 5, 2023
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 884.5300
• Device Class: Class 2

Intended Use

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

Device Story

Single-use natural rubber latex sheath; covers penis; textured with dots along straight shaft; includes reservoir tip; coated with silicone lubricant. Used by consumers for contraception and STI prevention. Provides physical barrier to contain semen and reduce transmission risk. No electronic or software components.

Clinical Evidence

No clinical data. Bench testing only. Biocompatibility testing (cytotoxicity, sensitization, vaginal irritation, acute systemic toxicity) per ISO 10993 standards. Physical property testing (burst volume, burst pressure) per ASTM D3492-16 and ISO 4074:2015. Accelerated stability testing supports 5-year shelf life.

Technological Characteristics

Material: Natural rubber latex. Lubricant: Silicone oil. Dusting agent: USP Grade Corn Starch. Dimensions: 190mm length, 53mm width, 0.08mm thickness. Standards: ASTM D3492-16, ISO 4074:2015. Non-sterile.

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

• FAMA Male Latex Condoms (K220576)

Submission Summary (Full Text)

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October 5, 2023

Suretex Limited % Donna DiGangi Principal DiGangi Consulting, LLC 708 Firethorn Lane Round Rock, TX 78664

Re: K232279

> Trade/Device Name: LifeStyles® NRL Textured Condom Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: HIS Dated: July 27, 2023 Received: July 31, 2023

Dear Donna DiGangi:

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.

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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 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 (OS) 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 medical devices and radiation-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.

# Michael T. Bailey -S

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) K232279

Device Name LifeStyles® NRL Textured Condom

Indications for Use (Describe)

The LifeStyles NRL Textured 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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K232279 Page 1 of 4

## 510(k) Summary K232279

## Submitter:

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

## Contact Person:

Alison Arnot Phone: [phone] Fax: [phone] Email: [e-mail]

#### Date Prepared:

September 28, 2023

#### Device Name:

| Trade Name: | LifeStyles® NRL Textured Condom |
|--------------------|----------------------------------|
| Common Name: | Male natural rubber latex condom |
| Regulation Name: | Condom |
| Regulation Number: | 21 CFR 884.5300 |
| Device Class: | Class II |
| Product Code: | HIS (Condom) |

#### Predicate Device Information:

| Trade Name: | FAMA Male Latex Condoms |
|--------------------|---------------------------------------------|
| 510K Number: | K220576 |
| Manufacturer: | Shanghai Personage Hygiene Products Co. Ltd |
| Common Name: | Male natural rubber latex condom |
| Regulation Name: | Condom |
| Regulation Number: | 21 CFR 884.5300 |
| Device Class: | Class II |
| Product Code: | HIS (Condom) |

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

#### Device Description:

The LifeStyles® NRL Textured Condom is indicated for contraception and for prophylactic purposes (to help reduce the risk of pregnancy and the transmission of sexually transmitted infections). The condom is a single use device made of a noncolored natural rubber latex sheath that covers the penis with a closely fitted membrane. The condom is textured with dots along its straight shaft, includes a reservoir tip at the closed end to contain semen, and is coated with a silicone lubricant. The LifeStyles® NRL Textured Condom has a nominal length of 190 mm, width of 53 mm, and thickness of 0.08 mm. Each condom is packaged individually in laminate foils that are secondarily packaged in cardboard shelf boxes.

The LifeStyles® NRL Textured Condom conforms with FDA-recognized consensus standards ASTM D3492-16 - Standard Specification for Rubber Contraceptives (male condoms) and ISO 4074:2015 - Natural Rubber Latex Condoms – Requirements and test methods.

| Parameter | Specification |
|---------------------------|---------------|
| Lubricant quantity (mg) | 400 – 600 |
| Length (mm) | 190±10 |
| Width (mm) | 53 ± 2 |
| Thickness (mm) | 0.080± 0.01 |
| Burst Volume, min (dm³) | 18 |
| Burst Pressure, min (kPa) | 1.0 |

#### Table 1. Condom Specifications

#### Indications for Use:

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

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## Comparison of Intended Use and Technological Characteristics with the Predicate Device

| Parameter | Subject Device | Predicate Device | Comparison |
|--------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Device Name | LifeStyles® NRL Textured<br>Condom<br>K232279 | FAMA Male Latex Condoms<br>K220576 | Same |
| Product Code | HIS | HIS | Same |
| Class | II | II | Same |
| Classification | 21 CFR 884.5300, Condom | 21 CFR 884.5300, Condom | Same |
| Indications for Use | The LifeStyles NRL Textured<br>Condom is used for<br>contraception and<br>prophylactic purposes (to<br>help prevent pregnancy and<br>the transmission of sexually<br>transmitted infections). | The FAMA Male Latex<br>Condoms are used for<br>contraception and<br>prophylactic purposes (to<br>help prevent pregnancy and<br>the transmission of sexually<br>transmitted infections). | Same |
| Prescription or Over<br>the Counter (OTC)<br>Use | OTC | OTC | Same |
| Style | Straight-walled, nipple ended | Straight-walled, nipple ended | Same |
| Texture | Dotted | Straight-walled, nipple ended<br>Smooth, ribbed, or dotted<br>texture | Different |
| Color Additives | No | No | Same |
| Formulation | Natural Rubber Latex | Natural Rubber Latex | Same |
| Lubricant | Silicone oil | Silicone oil | Same |
| Dusting Agent | USP Grade Corn Starch | Silicon dioxide | Different |
| Length (mm) | $190\pm10$ | $180\pm10$ | Different |
| Width (mm) | $53 \pm 2$ | $53 \pm 2$ | Same |
| Thickness (mm) | $0.080mm \pm 0.01$ | 0.068 - 0.069 | Different |
| Burst Volume (dm³) | ≥18 | ≥18 | Same |
| Burst Pressure(kPa) | ≥1.0 | ≥1.0 | Same |
| Sterile | No | No | Same |
| Shelf Life | 5 years | 5 years | Same |

| | Table 2. Technological Characteristics and Comparison to the Predicate Device | | |
|--|-------------------------------------------------------------------------------|--|--|
| | | | |

The subject device has the same indications for use and intended use as the predicate device. The subject and predicate devices have differences in their technological characteristics (e.g., dusting agent, texture, length and thickness); however, these differences do not raise different questions of safety and effectiveness.

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#### Summary of Non-Clinical Performance testing

#### Biocompatibility

Biocompatibility studies were performed in accordance with the 2020 FDA guidance document Use of International Standard ISO 10993-1, "Biological Evaluation of Medical Devices - Part 1: Evaluation and testing within a risk management process", as summarized below:

- Cytotoxicity (ISO 10993-5:2009) ●
- . Sensitization (ISO 10993-10:2010)
- Vaginal Irritation (ISO 10993-10:2010)
- Acute Systemic Toxicity (ISO 10993-11:2017)

The results of testing demonstrate that the subject device is non-cytotoxic, nonirritating, non-sensitizing, and not acutely systemically toxic.

#### Physical Property Testing

The LifeStyles® NRL Textured Condom was tested and met the requirements 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

The LifeStyles® NRL Textured Condom has a five-year shelf life based on the results of accelerated stability evaluations conducted as required in 21 CFR 801.435. All samples met predefined acceptance criteria.

#### Conclusion

The results of performance testing demonstrate that the LifeStyles® NRL Textured Condom is as safe and effective as the predicate device and supports a determination of substantial equivalence.