(123 days)
Not Found
No
The device description and performance studies focus on the physical properties and testing of a natural rubber latex condom, with no mention of AI or ML.
No.
The device is clearly stated as being used for contraception and prophylactic purposes, not for treating a disease or condition.
No
The device is a condom, used for contraception and preventing STIs, not for diagnosing medical conditions.
No
The device description clearly states it is a physical condom made of natural rubber latex, which is a hardware component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for contraception and prevention of sexually transmitted infections. This is a physical barrier method, not a test performed on a sample from the human body to provide information about a physiological state, disease, or condition.
- Device Description: The description details a physical condom made of latex. It doesn't describe any components or processes related to analyzing biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Testing of biological samples (blood, urine, tissue, etc.)
- Reagents or assays
- Measurement of analytes
- Diagnostic information
The device is a medical device, specifically a condom, but it falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
The Lelo Hex Lubricated Natural Rubber Latex Condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted infections).
Product codes
HIS
Device Description
The Lelo Hex Lubricated Natural Rubber Latex Condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted infections).
It is a straight walled textured condom with a nipple end and made of natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. It has a nominal length of 190 ± 10 mm, nominal width of 54 ± 2 mm and nominal thickness of 0.06 ± 0.01 mm.
Lelo Hex Lubricated Natural Rubber Latex Condom is packaged in individually sealed flexible laminate foils which is then packaged into an outer consumer cardboard carton. The Lelo Hex Lubricated Natural Rubber Latex Condom is intended for over-the-counter (OTC) use. These condoms conform with FDA-recognized standards ASTM D3492-16 and ISO 4074:2015.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Over-The-Counter Use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Biocompatibility:
Biocompatibility studies, including Acute Systemic Toxicity, Vaginal Irritation, Cytotoxicity, and Sensitization testing, were performed in accordance with the 2023 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" and ISO 10993-1:2009 as follows:
- Cytotoxicity (ISO 10993-5:2009/R 2014)
- Sensitization (ISO 10993-10:2021)
- Vaginal Irritation (ISO 10993-10:2021)
- Acute Systemic Toxicity (ISO 10993-11:2017)
The result of testing demonstrates that the subject device is non-cytotoxic, non-irritating, nonsensitizing, and non-acutely, systemically toxic.
Physical Performance Testing:
The Lelo Hex Lubricated Natural Rubber Latex Condom was tested and met all the requirements of ISO 4074:2015 "Natural rubber latex male condom – Requirement and test methods" and ASTM D3492-16 "Standard Specification for Rubber Contraceptives (Male Condoms)" for dimensional, tensile strength, force at break, lubricant quantity, visible defects, elongation, air burst volume and air burst pressure requirements.
Shelf Life:
The Lelo Hex Lubricated Natural Rubber Latex Condom has a three-year shelf-life based on the results of accelerated stability evaluation conducted as required in 21 CFR 801.435. All samples met predefined acceptance criteria.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 884.5300 Condom.
(a)
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.(b)
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.
0
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & 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.
March 7, 2025
Lelo Inc. % Kevin Walls Principal Consultant Regulatory Insight, Inc. 33 Golden Eagle Lane Littleton. CO 80127
Re: K243421
Trade/Device Name: Lelo Hex Lubricated Natural Rubber Latex Condom Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: HIS Dated: November 2, 2024 Received: January 29, 2025
Dear Kevin Walls:
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: 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.
1
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 System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100. Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 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-reportingcombination-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 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-device-advicecomprehensive-regulatory-assistance/unique-device-identification-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-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
2
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
3
Indications for Use
510(k) Number (if known) K243421
Device Name
Lelo Hex Lubricated Natural Rubber Latex Condom
Indications for Use (Describe)
The Lelo Hex Lubricated 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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4
510(k) Summary K243421 Lelo Hex Lubricated Latex Condom
1. Submitter Information
Applicant: Lelo Inc. Address: 5799 Fontanoso Way San Jose, CA 95138, Phone: (877) 872-5356
2. Correspondent Information
Company: Regulatory Insight Contact: Kevin Walls Address: 33 Golden Eagle Lane Littleton, CO 80127 Phone: (720) 962-5412 Email: kevin@reginsight.com
3. Date Prepared: March 7, 2025
4. Device Information
Device Name: Lelo Hex Lubricated Natural Rubber Latex Condom Common Name: Male Natural Rubber Latex Condom Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Product Code: HIS (Condom) Regulatory Class: Class II
5. Predicate Device Information
Device Name: One Touch Spiral Condom 510(k) Number: K210294 Sponsor: Thai Nippon Rubber Industry Public Company Limited
The predicate device has not been subject to a design-related recall.
6. Device Description
The Lelo Hex Lubricated Natural Rubber Latex Condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted infections).
It is a straight walled textured condom with a nipple end and made of natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. It has a nominal length of 190 ± 10 mm, nominal width of 54 ± 2 mm and nominal thickness of 0.06 ± 0.01 mm.
5
K243421 Page 2 of 3
Lelo Hex Lubricated Natural Rubber Latex Condom is packaged in individually sealed flexible laminate foils which is then packaged into an outer consumer cardboard carton. The Lelo Hex Lubricated Natural Rubber Latex Condom is intended for over-the-counter (OTC) use. These condoms conform with FDA-recognized standards ASTM D3492-16 and ISO 4074:2015.
7. Indications for Use Statement
The Lelo Hex Lubricated Natural Rubber Latex Condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted infections).
-
- Comparison of Intended Use and Technological Characteristics with the Predicate Device The table below includes a comparison of the intended use and technological characteristics of the subject and predicate devices.
| Subject Device | Predicate Device | |
|---|---|---|
| Device & Predicate Device | Lelo Hex Lubricated Latex | |
| Condom | One Touch Spiral Condom | |
| 510(K) Number | K240679 | K210294 |
| Product Code | HIS | HIS |
| Regulation Number | 21 CFR 884.5300 | 21 CFR 884.5300 |
| Regulation Name | Condom | Condom |
| Indications for Use | The Lelo Hex Lubricated Latex | |
| Condom is used for | ||
| contraception and for | ||
| prophylactic purposes (to help | ||
| prevent pregnancy and the | ||
| transmission of sexually | ||
| transmitted infections). | The One Touch Spiral Condom | |
| is used for contraception and | ||
| for prophylactic purposes (to | ||
| help prevent pregnancy and | ||
| the transmission of sexually | ||
| transmitted infections). | ||
| Prescription or Over-The- | ||
| Counter Use | Over-The-Counter | Over-The-Counter |
| Condom Material | Natural Rubber Latex | Natural Rubber Latex |
| Nominal Width | 54 ± 2 mm | 52 ± 2mm |
| 54 ± 2mm | ||
| Nominal Length | 190 ± 10 mm | 190 ± 10 mm |
| Nominal Thickness | 0.060 ± 0.010 mm | 0.080 ± 0.010 mm |
| Lubricant | L Arginine Lubricant | Silicone Oil |
| Lubricant Quantity | 550 ± 150 mg | Not publicly available |
| Air Burst Pressure | >1.0 kPa | Not publicly available; met |
| the criteria specified in ISO | ||
| 4074:2015, Natural latex | ||
| rubber condoms - | ||
| Requirements and test | ||
| methods | ||
| Air Burst Volume | >18.0 L | the criteria specified in ISO |
| 4074:2015, Natural latex | ||
| rubber condoms - | ||
| Requirements and test | ||
| methods | ||
| Sterilization | Non-sterile | Non-sterile |
| Shape | Straight walled, nipple end | Straight wall, spiral head with |
| nipple end (Single and double | ||
| spiral) | ||
| Texture | Hexagonal Textured | Smooth |
| Shelf life | 3 years | 5 years |
6
The subject and predicate device have identical indications for use statements, with the exception of device name, and the same intended use - for contraception and for prophylactic purposes. The technological characteristics of the subject device and predicate device are similar in that they are natural rubber latex-based and lubricated. The subject and predicate device have different technological characteristics, including different dimensions, shelf-life, lubricant formulation, and texture. These differences do not raise different questions of safety and effectiveness.
9. Summary of Non-Clinical Performance Testing
Biocompatibility:
Biocompatibility studies, including Acute Systemic Toxicity, Vaginal Irritation, Cytotoxicity, and Sensitization testing, were performed in accordance with the 2023 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" and ISO 10993-1:2009 as follows:
- Cytotoxicity (ISO 10993-5:2009/R 2014)
- Sensitization (ISO 10993-10:2021)
- Vaginal Irritation (ISO 10993-10:2021)
- . Acute Systemic Toxicity (ISO 10993-11:2017)
The result of testing demonstrates that the subject device is non-cytotoxic, non-irritating, nonsensitizing, and non-acutely, systemically toxic.
Physical Performance Testing:
The Lelo Hex Lubricated Natural Rubber Latex Condom was tested and met all the requirements of ISO 4074:2015 " Natural rubber latex male condom – Requirement and test methods" and ASTM D3492-16 "Standard Specification for Rubber Contraceptives (Male Condoms)" for dimensional, tensile strength, force at break, lubricant quantity, visible defects, elongation, air burst volume and air burst pressure requirements.
Shelf Life:
The Lelo Hex Lubricated Natural Rubber Latex Condom has a three-year shelf-life based on the results of accelerated stability evaluation conducted as required in 21 CFR 801.435. All samples met predefined acceptance criteria.
10. Conclusion
The results of the performance testing described above demonstrate that the Lelo Hex Lubricated Natural Rubber Latex Condom is as safe and effective as the predicate device and supports a determination of substantial equivalence.