Male Latex Condom HA

K252622 · Okamoto USA, Inc. · HIS · May 4, 2026 · Obstetrics/Gynecology

Device Facts

• Record ID: K252622
• Device Name: Male Latex Condom HA
• Applicant: Okamoto USA, Inc.
• Product Code: HIS · Obstetrics/Gynecology
• Decision Date: May 4, 2026
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 884.5300
• Device Class: Class 2

Indications for Use

The Male Latex Condom HA is used for contraceptive and prophylactic purposes (preventing transmission of sexually transmitted infections).

Device Story

Male Latex Condom HA is a natural rubber latex sheath designed to cover the penis. It features a smooth-surfaced, straight-walled, teat-ended design with a water-based lubricant containing hyaluronic acid. The device is intended for over-the-counter use by individuals for contraception and the prevention of sexually transmitted infections. It functions as a physical barrier. The device is manufactured to meet ASTM D3492: 2016 standards for physical dimensions and integrity. Clinical benefit is derived from its barrier properties, which prevent pregnancy and the transmission of STIs.

Clinical Evidence

Bench testing only. Physical testing (air burst, water leakage) performed on three lots per ASTM D3492-16. Shelf-life stability validated per 21 CFR 801.435 and ISO 4074:2015. Biocompatibility testing conducted per ISO 10993-1, including cytotoxicity (ISO 10993-5), sensitization (ISO 10993-10), vaginal irritation (ISO 10993-23), and acute systemic toxicity (ISO 10993-11). Results confirmed the device is non-irritating, non-sensitizing, and non-cytotoxic.

Technological Characteristics

Natural rubber latex sheath; water-based lubricant with hyaluronic acid; straight-walled, teat-ended; nominal length 180mm, width 53.5mm, thickness 0.04mm. Conforms to ASTM D3492: 2016. Biocompatibility per ISO 10993 series. Shelf life 5 years.

Indications for Use

Indicated for contraceptive and prophylactic purposes, including the prevention of sexually transmitted infections, for use by individuals requiring a male latex condom.

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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FDA U.S. FOOD & DRUG ADMINISTRATION

May 4, 2026

Okamoto USA, Inc.
% Jeff Gibbs
Director
Hyman, Phelps & McNamara, P.C.
700 Thirteenth St. NW
Suite 1200
Washington, District of Columbia 20005

Re: K252622
Trade/Device Name: Male Latex Condom HA
Regulation Number: 21 CFR 884.5300
Regulation Name: Condom
Regulatory Class: II
Product Code: HIS
Dated: August 19, 2025
Received: April 3, 2026

Dear Jeff Gibbs:

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 (the 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 available 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: The Center for Devices and Radiological Health (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, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the Federal Register.

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

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K252622 - Jeff Gibbs
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3).

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 device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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

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K252622 - Jeff Gibbs
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the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/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,

Monica D. Garcia -S

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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FORM FDA 3881 (6/20)
Page 1 of 1
PSC Publishing Services [phone]
EF

| DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use | Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below. |
| --- | --- |
| 510(k) Number (if known) K252622 | |
| Device Name Male Latex Condom HA | |
| Indications for Use (Describe) The Male Latex Condom HA is used for contraceptive and prophylactic purposes (preventing 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) | |
| CONTINUE ON A SEPARATE PAGE IF NEEDED. | |
| This section applies only to requirements of the Paperwork Reduction Act of 1995. "DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW." | |
| The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail] | |
| "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." | |

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K252662 Page 1

# 510(k) Summary – K252662

## I. Submitter Information

Submitter Name: OKAMOTO USA, INC.

Submitter Address: 3130 West Monroe Street Sandusky OH 44870 United States

Submitter Contact Person: Mr. Kenji Komatsu

Phone: [phone]

E-mail: [e-mail]

Preparer Name: Mr. Jeff Gibbs

Hyman, Phelps & McNamara, P.C.

700 Thirteenth St. NW Suite 1200 Washington DC 20005 United States

Phone: [phone]

E-mail: [e-mail]

## II. Date Prepared:

May 4, 2026

## III. Subject Device Information

Trade Name: Male Latex Condom HA

Common Name: Natural rubber latex male condom

Regulation Name: Condom

Regulation Number: 21 CFR 884.5300

Product Code: HIS (condom)

Regulatory Class: Class II

## IV. Predicate Device

Submission Number: K192669

Device Trade Name: Extremely Thin 003, ZERO ZERO THREE

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

## V. Description of Device

The Male Latex Condom HA is made of a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane.

This device is a smooth-surfaced, straight-walled, teat-ended, water-based natural rubber condom with a water-based lubricant that includes hyaluronic acid. It has a nominal length of 180 mm, nominal width of 53.5 mm, and nominal thickness of 0.04 mm. This condom conforms to the currently recognized standard ASTM D3492: 2016.

## VI. Indications for Use:

The Male Latex Condom HA is used for contraceptive and prophylactic purposes (preventing transmission of sexually transmitted infections).

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K252662 Page 2

# VII. Comparison of Intended Use and Technological Characteristics of the Subject Device and Predicate Device

The table below compares the intended use and technological characteristics of the subject device and predicate device.

| | Subject Device Male Latex Condom HA (K252662) | Predicate Device Extremely Thin 003, ZERO ZERO THREE (K192669) | Discussion |
| --- | --- | --- | --- |
| Indications for Use | The Male Latex Condom HA is used for contraceptive and prophylactic purposes (preventing transmission of sexually transmitted infections). | The condom is used for contraception and for prophylactic purposes (preventing transmission of sexually transmitted infections.) | Identical |
| Principal Raw Material of Condom Sheath | Natural Rubber Latex | Natural Rubber Latex | Identical |
| Color | No color | No color | Identical |
| Raw Material of Lubricant | Water-based with hyaluronic acid lubricant | Silicone | Different |
| Shape | Straight-walled & Reservoir-ended | Straight-walled & Reservoir-ended | Identical |
| Surface Texture | Smooth Surface | Smooth Surface | Identical |
| Nominal Length (mm) | 180 ± 10 mm | 180 ± 10 mm | Identical |
| Nominal Width at 30mm from open end (mm) | 53.5 ± 2 mm | 53.2 ± 2 mm | Similar |
| Nominal Thickness (mm) | 0.04 ± 0.01 mm | 0.04 ± 0.01 mm | Identical |
| Air Burst Test Pressure | >1.0 kPa | >1.0 kPa | Identical |
| Air Burst Test Volume | >18 L (dm3) | >18 L (dm3) | Identical |
| Water Leakage | No leakage | No leakage | Identical |
| Shelf Life | 5 Years | 5 years | Identical |

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K252662 Page 3

The subject device and predicate device have the same indications for use statements and the same intended use to prevent pregnancy and the transmission of sexually transmitted infections. The subject and predicate devices have different technological characteristics (e.g., formulation, lubricant and dimensions). These differences do not raise different questions of safety and effectiveness.

## VIII. Summary of Non-Clinical Performance Testing

**Physical Testing:** Three (3) lots of Male Latex Condom HA were tested at baseline and met air burst specifications of ASTM D3492-16 Standard Specifications for Rubber Contraceptives (Male Condoms).

**Shelf Life:** Stability of the Male Latex Condom HA was established from results of physical testing data using a protocol that followed 21 CFR 801.435 and met the requirements of both ASTM D3492-16 and ISO 4074:2015. Based on the evaluation of the results of the physical testing data, the expiration date has been initially set at 5 years and will be then verified through real-time stability through five (5) years in compliance with FDA expiration labeling requirements in 21 CFR 801.435.

**Biocompatibility:** Biocompatibility evaluations were performed on the Male Latex Condom HA in accordance with the 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" dated September 2023. The biocompatibility evaluations conducted, and the applicable ISO standards are listed below:

- Cytotoxicity Elution Method ISO 10993-5:2009
- Guinea Pig Maximization Sensitization ISO 10993-10:2021, ISO 10993-12:2021
- Vaginal Irritation ISO 10993-23:2012, ISO 10993-12:2021
- Acute Systemic Toxicity ISO 10993-11:2017, ISO 10993-12: 2021

The results of these evaluations demonstrate that the subject device is non-irritating, non-sensitizing, and non-cytotoxic.

## IX. Conclusion:

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