JUD custom fit condom

K172414 · Global Mailer Partners, LLC · HIS · Oct 12, 2017 · Obstetrics/Gynecology

Device Facts

• Record ID: K172414
• Device Name: JUD custom fit condom
• Applicant: Global Mailer Partners, LLC
• Product Code: HIS · Obstetrics/Gynecology
• Decision Date: Oct 12, 2017
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 884.5300
• Device Class: Class 2

Indications for Use

The JUD custom fit condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases).

Device Story

JUD custom fit condom is a natural rubber latex sheath designed to cover the penis; features reservoir end and cylindrical shape. Available in 23 distinct length/width combinations to provide a custom fit. User selects appropriate size using provided fitting kit and instructions. Pre-lubricated with silicone-based lubricant; contains no spermicide, flavors, or color additives. Used by individuals for contraception and prophylactic protection against sexually transmitted diseases. Principle of operation involves physical barrier placement on erect penis prior to sexual contact to prevent transmission of bodily fluids and infectious organisms. Benefits include improved fit through size selection, potentially enhancing comfort and effectiveness.

Clinical Evidence

Bench testing only. Testing performed per ISO 4074:2015 and WHO 2010 standards, including dimensional analysis, lubricant quantity, burst volume/pressure, freedom from holes, and package seal integrity. Biocompatibility testing conducted per ISO 10993 series (cytotoxicity, acute systemic toxicity, vaginal irritation, skin sensitization) confirmed no adverse reactivity. Shelf-life testing validated 5-year stability.

Technological Characteristics

Material: Natural rubber latex. Design: Cylindrical sheath with reservoir tip. Dimensions: 23 variants (lengths 130-199mm, widths 45-64mm). Lubricant: Silicone-based. Sterilization: Not specified. Connectivity: None. Software: None. Standards: ISO 4074:2015, ISO 10993.

Indications for Use

Indicated for contraception and prevention of pregnancy and sexually transmitted diseases 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

• They Fit Condom (K150072)

Reference Devices

• They Fit Condom (K122219)

Submission Summary (Full Text)

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#### 510(k) SUMMARY

| Date of Summary: | September 26, 2017 |
|-------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Applicant: | Global Mailer Partners, LLC<br>50 South Pointe Drive,<br>Suite 1401,<br>Miami Beach, LF 33139<br>Jud Ireland, CEO<br>516-279-7745<br>[e-mail] |
| Contact Person: | Adam Harris, MM, RAC<br>Regulatory Consultant<br>Associate Director, Regulatory Affairs<br>Target Health Inc.<br>261 Madison Ave 24th Floor<br>New York, NY 10016<br>Phone: [phone]<br>Fax: [phone]<br>[e-mail] |
| Proprietary/Trade Name: | JUD custom fit condom |
| Common Name: | Male Latex Condom |
| Classification Name: | Condom |
| Device Classification | Class II per 21 CFR §884.5300 |
| Product Code | HIS, Condom |
| Predicate Device | They Fit Condom K150072 |
| Reference Device | They Fit Condom K122219 |

The predicate and reference devices have not been subject to a design-related recall.

#### Device Description:

The JUD custom fit condom is made of a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. The condom is shaped with a reservoir end and is flat with a cylindrical shape. JUD custom fit condoms are available in 23 sizes of different length/width combinations. There is a fitting kit and instructions included as part of safe and effective usage of the condom.

JUD custom fit condoms are provided pre-lubricated with a silicone-based lubricant. JUD custom fit condoms are not provided with spermicide, and contain no flavors or color additives. The user must use a fitting kit to select the appropriate size of the JUD custom fit condom.

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# Indications for Use

The JUD custom fit condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases).

| | SIZE<br>CODE | LENGTH<br>(mm) | WIDTH (mm) |
|-----|--------------|----------------|------------|
| 1. | 54W | 130 | 45 |
| 2. | 54E | 130 | 47 |
| 3. | 54J | 130 | 51 |
| 4. | 36J | 150 | 51 |
| 5. | 75J | 173 | 51 |
| 6. | 54M | 130 | 49 |
| 7. | 36M | 150 | 49 |
| 8. | 54N | 130 | 57 |
| 9. | 36N | 150 | 57 |
| 10. | 75N | 173 | 57 |
| 11. | 29N | 199 | 57 |
| | SIZE CODE | LENGTH (mm) | WIDTH (mm) |
| 12. | 36P | 150 | 60 |
| 13. | 75P | 173 | 60 |
| 14. | 29P | 199 | 60 |
| 15. | 75R | 173 | 64 |
| 16. | 29R | 199 | 64 |
| 17. | 54S | 130 | 53 |
| 18. | 36S | 150 | 53 |
| 19. | 75S | 173 | 53 |
| 20. | 54U | 130 | 55 |
| 21. | 36U | 150 | 55 |
| 22. | 75U | 173 | 55 |
| 23. | 29U | 199 | 55 |

# Comparison of Technological Characteristics

| Characteristic | Subject Device | Predicate Device | Reference Device | Comparison |
|---------------------|------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------|-----------------------------------------------------------------------------|------------|
| Device Name | Jud custom fit condom | They Fit Condom | They Fit Condom | N/A |
| 510(k) Number | K172414 | K150072 | K122219 | N/A |
| Common Name | Male Latex Condom | Male Latex Condom | Male Latex Condom | N/A |
| Manufacturer | Richter Rubber Technology, Sdn. Bhd.<br>Plot 33 Kuala Ketil Industrial Estate, 09300 Kuala Ketil, Malaysia | They Fit Condom Michael Cecil, MD<br>4140 Tate Street Covington, GA 30014 | They Fit Condom Michael Cecil, MD<br>4140 Tate Street Covington, GA 30014 | N/A |
| Indications for Use | The JUD custom fit condom is used for contraception and for prophylactic purposes (to help | The condom is used for contraception and for prophylactic purposes to help | The condom is used for contraception and for prophylactic purposes (to help | Same |

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| | prevent pregnancy<br>and the transmission<br>of sexually<br>transmitted<br>diseases). | prevent pregnancy<br>and the<br>transmission of<br>sexually<br>transmitted<br>diseases. | prevent pregnancy<br>and the<br>transmission of<br>sexually<br>transmitted<br>diseases). | |
|----------------------|---------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------|
| Size(s) | Varied sizes with<br>different<br>length/width<br>combinations. | Varied sizes with<br>different<br>length/width<br>combinations. | Varied sizes with<br>different<br>length/width<br>combinations. | Same |
| Length | 130mm, 150mm,<br>173mm, 199mm | 123mm, 133mm,<br>143mm, 153mm | 163mm, 178mm,<br>193mm, 208mm | Different;<br>subject<br>device<br>lengths fall<br>within the<br>range of the<br>predicate<br>and<br>reference<br>devices. |
| Width | 45 mm, 47mm,<br>49mm, 51mm,<br>53mm, 55mm,<br>57mm, 60mm,<br>64mm | 45mm, 47mm,<br>49mm, 51mm,<br>53mm, 57mm,<br>60mm, 64mm | 49mm, 51mm,<br>53mm, 55mm,<br>57mm, 60mm,<br>64mm | Same |
| Reservoir tip | yes | yes | yes | Same |
| Single use<br>device | yes | yes | yes | Same |
| Natural Latex | yes | yes | yes | Same |

The principle of operation of the JUD custom fit condoms, placing condom on erect penis before sexual contact to avoid transmission of bodily fluid and infectious organisms within, is identical to predicate. As noted in the table above, JUD custom fit condoms have the same indications for use and basic technological characteristics as the predicate and reference condoms. The JUD custom fit condoms are made of natural rubber latex, are prelubricated, and have similar sizes to the predicate. The JUD custom fit condom dimensions fall within the range of sizes of the predicate and reference devices, though they are offered in different size configurations. The difference in available sizes of the JUD custom fit condoms does not raise different questions of safety and effectiveness.

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# Nonclinical Testing Summary

#### Bench testing

Dimensional tests, burst volume and pressure tests, and freedom from holes and visible defects tests have been conducted per WHO 2010 and ISO 4074:2015. Package seal integrity test has been conducted per ISO 4074:2015. The dimensions and burst volume and pressure of the condoms tested conform to the aforementioned standards. There were no visible defects or damaged package seal identified in the tested samples.

| Description | Summary and Conclusion |
|----------------------------------------|-----------------------------------|
| Dimensional | ISO 4074: Acceptance criteria met |
| Lubricant quantity | ISO 4074: Acceptance criteria met |
| Burst Volume and Pressure | ISO 4074: Acceptance criteria met |
| Freedom from Holes and Visible Defects | ISO 4074: Acceptance criteria met |
| Package Seal Integrity | ISO 4074: Acceptance criteria met |

## Shelf Life

The JUD custom fit condom has a shelf-life of 5 years. The results of shelf life testing show that each condom variant maintained its specifications for the proposed shelf-life.

## Biocompatibility

The JUD custom fit condom is considered a surface contacting device of category A – limited contact of <24 hours on intact skin/mucosal membrane. The skin contacting component is the latex condom itself made from natural latex rubber. These condoms contain no flavors or color additives.

| The following biocompatibility testing was conducted on the JUD custom fit condom: | |
|------------------------------------------------------------------------------------|--|
|------------------------------------------------------------------------------------|--|

| Biological<br>Endpoint | Description | ISO Standard | Results | Test article |
|-------------------------------|----------------------------------------------------------|-----------------------|-------------------------------------------------------------------------------------------------------------------|--------------------------------------|
| Cytotoxicity | In-vitro cytotoxicity_using<br>the direct contact method | ISO 10993-<br>5:2009 | No cytotoxic<br>reactivity was found | Identical to<br>finished<br>devices* |
| Acute<br>systemic<br>toxicity | Systemic toxicity in Swiss<br>albino mice | ISO 10993-<br>11:2006 | There was no<br>mortality or evidence<br>of systemic toxicity<br>resulted from the test<br>article extract. | Identical to<br>finished<br>devices |
| Vaginal<br>irritation | Vaginal irritation in rabbits | ISO 10993-<br>10:2010 | The test article was<br>found to be non-<br>irritating, i.e., did not<br>show any signs of<br>vaginal irritation. | Identical to<br>finished<br>devices |
| Skin | Skin sensitization | ISO 10993- | The test article | Identical to |

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| sensitization | (maximization) test in<br>Guinea Pigs | 10:2010 | extract did not<br>induce skin<br>sensitization. | finished<br>devices |
|---------------|---------------------------------------|---------|--------------------------------------------------|---------------------|
|---------------|---------------------------------------|---------|--------------------------------------------------|---------------------|

*The test article utilized for the biocompatibility testing was a single condom variant. All JUD custom fit condoms undergo the same manufacturing process, have the same chemical, physical, and surface properties, and have the same ratio of component materials as the test article.

## Substantial Equivalence Conclusion

The subject device is identical to the predicate devices in intended use. The subject device, predicate and reference devices are constructed out of the same materials (natural rubber latex), and have the same basic technological characteristics. The subject device dimensions fall within those of the predicate and reference devices, though the subject device has slightly different size configurations. Both the subject device and predicate devices conform to the same standards for performance specifications. Differences in technological characteristics between the subject and predicate devices do not raise different questions of safety and effectiveness. The non-clinical testing conducted on the subject device, including dimensional testing, lubricant quantity, burst volume and pressure testing, freedom from holes and visible defects testing, package seal integrity, shelf life, cytotoxicity, acute systemic toxicity, vaginal irritation and skin sensitization demonstrate that the subject device is as safe and effective as the predicate. Therefore, the JUD custom fit condom is substantially equivalent to the predicate, TheyFit.

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Image /page/6/Picture/2 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" arranged around the perimeter. Inside the seal is a stylized image of three human profiles facing to the right, forming a symbolic representation of people.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

October 12, 2017

Global Mailer Partners, LLC % Adam Harris. MM. RAC Associate Director, Regulatory Affairs Target Health, Inc. 261 Madison Avenue, 24th Floor New York, NY 10016

Re: K172414 Trade/Device Name: JUD custom fit condom Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: HIS Dated: August 9, 2017 Received: August 10, 2017

Dear Adam Harris:

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 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 (reporting of medical devicerelated 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 (DICE) 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 (DICE) at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

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