(134 days)
Not Found
No
The device description and performance studies focus solely on the physical properties and testing of a natural rubber latex condom, with no mention of AI or ML technologies.
No
The device is described as being used for contraception and prophylactic purposes, which are preventative rather than therapeutic.
No
The device description and intended use clearly state that the Microthin Natural Rubber Latex Condom is for contraception and prophylactic purposes, not for diagnosing any condition.
No
The device description clearly states it is a physical product made of natural rubber latex, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device's Intended Use: The intended use of the Microthin Natural Rubber Latex Condom is for contraception and prophylactic purposes (preventing pregnancy and STIs). This is a physical barrier method used externally on the body.
- Device Description: The description clearly outlines a physical device designed to cover the penis. It doesn't mention any components or processes related to testing biological samples.
- Lack of IVD-related information: The document lacks any information typically associated with IVDs, such as:
- Mention of biological samples (blood, urine, etc.)
- Testing procedures or assays
- Analytical or clinical performance metrics like sensitivity, specificity, AUC, etc. (which are crucial for evaluating the accuracy of diagnostic tests)
The information provided describes a Class II medical device used for physical contraception and disease prevention, not a diagnostic test performed on biological samples.
N/A
Intended Use / 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).
Product codes (comma separated list FDA assigned to the subject device)
HIS
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.
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
Not Found
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)
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 guidance 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.
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 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.
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
2
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)
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 PRAStaff(@fda.hhs.gov
"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."
3
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: +66 77 277 400 Fax: +66 77 277 428 Email: kc.nguyen@lifestyles.com
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.
4
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
K213921 | Predicate Device
K192669 | Comparison |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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). | The condom is used for
contraception and for
prophylactic purposes
(preventing
transmission of
sexually transmitted
infections). | The subject and
predicate
indications for
use are not
identical, but
both have the
same intended
use (i.e., to
prevent
pregnancy and
transmission of
sexually
transmitted
infections). |
| Condom
Material | Natural Rubber Latex | Natural Rubber Latex | Same |
5
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
| Width | $52 \pm 2$ mm | $53.2 \pm 2$ mm | Different |
|---|---|---|---|
| Nominal | |||
| Length | $170 \pm 10$ mm | $180 \pm 10$ mm | Different |
| Nominal | |||
| Thickness | $0.035 \pm 0.005$ | 30 mm from closed end: | |
| $0.039 \pm 0.0013$ | |||
| 90 mm from closed end: | |||
| $0.039 \pm 0.001$ | |||
| 150 mm from closed | |||
| end: $0.039 \pm 0.001$ | Different | ||
| Lubricant | Silicone | Silicone | Same |
| Color | |||
| Additives | No color | No color | Same |
| Flavor | |||
| Additives | No flavor | No flavor | Same |
| Shape | Straight-walled | ||
| Reservoir-ended | Straight-walled | ||
| Reservoir-ended | Same | ||
| Texture | Smooth Surface | Smooth Surface | Same |
| Bursting | |||
| Pressure | |||
| (kPa) | Minimum of 1 kPa | $1.42 \pm 0.10$ | Different |
| Bursting | |||
| Volume | |||
| (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.
6
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.