(158 days)
Not Found
No
The device description and performance studies focus on the physical properties and biocompatibility of a latex condom, with no mention of AI or ML technology.
No
The device is primarily used for contraception and prophylaxis against sexually transmitted infections, not for treating existing medical conditions.
No
The device is described for contraceptive and prophylactic (prevention) purposes, not for diagnosing any condition.
No
The device description clearly states it is a physical product made of natural rubber latex and other materials, intended for physical use. There is no mention of software components.
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, or tissue) to detect diseases, conditions, or infections.
- Device Function: The FAMA Male Latex Condoms are a barrier device used for contraception and preventing the transmission of sexually transmitted infections. They do not perform any tests on bodily samples.
- Intended Use: The intended use clearly states "contraception and prophylactic purposes," which aligns with a barrier method, not a diagnostic test.
- Device Description: The description details the physical characteristics and materials of the condom, not components or processes related to analyzing biological samples.
Therefore, based on the provided information, the FAMA Male Latex Condoms are a medical device, but they fall under a different category than In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The FAMA Male Latex Condoms are 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 FAMA Male Latex Condoms are single-use, non-sterile condoms made of a natural rubber latex sheath, which covers the penis with a closely fitted membrane. The condoms have a smooth, dotted or ribbed surface and have a straight-walled nipple-end (SWNE) style within specifications listed in ASTM D3492-16, Standard Specification for Rubber Contraceptives (Male Condoms are lubricated with no colorants and fragrances added. The product is made of natural rubber latex, additives are sulfur, zinc oxide, promoter PX, promoter ZDC, antioxidant 264, stabilizer casein, and silicone oil as lubricant. 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
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)
Biocompatibility studies, including Acute Systemic Toxicity, Vaginal Irritation Testing, Cytotoxicity and Sensitization testing 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" and ISO 10993-1:2009. The results demonstrated that the subject devices are non-cytotoxic, non-irritating, non-sensitizing, and not systemically toxic.
Physical testing was performed at baseline and met all the requirements of ISO 4074:2015 - Natural rubber latex male condoms – Requirements and test methods and ASTM D3492-16 - Standard Specification for Rubber Contraceptives (Male Condoms).
Shelf-life testing was conducted based on accelerated stability evaluations as required in 21 CFR 801.435. All samples met predefined acceptance criteria. This supports a five-year shelf life.
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 logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 5, 2022
Shanghai Personage Hygiene Products Co.,Ltd. % Vincent Zhou Regulatory Manager Medwheat. Inc. 7900 International Drive, Suite 300 Bloomington, MN 55425
Re: K220576
Trade/Device Name: FAMA Male Latex Condoms Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: HIS Dated: June 30, 2022 Received: July 6, 2022
Dear Vincent Zhou:
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,
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) K220576
Device Name FAMA Male Latex Condoms
Indications for Use (Describe)
The FAMA Male Latex Condoms are 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
K220576 Page 1 of 4
510(k) Summary - K220576
1. Submitter Information
| Applicant: | Shanghai Personage Hygiene Products Co., Ltd |
|---|---|
| Address: | 88 Tianchen Road, Qingpu District, |
| Shanghai, 201700, China | |
| Phone: | 86-021-69214099 |
| Email: | haijiang_song@shbon.com |
2. Correspondent Information
| Contact: | Vincent Zhou |
|---|---|
| Phone: | |
| Email: | Medwheat Inc. |
| 001-612-806-2995 | |
| Info@medwheat.com |
3. Date prepared: August 03, 2022
4. Device Information
| Device/Trade Name: | FAMA Male Latex Condoms |
|---|---|
| Common Name: | Male Natural Rubber Latex Condom |
| Regulation Number: | 21 CFR 884.5300 |
| Regulation Name: | Condom |
| Regulatory Class: | Class II |
| Product Code: | HIS (Condom) |
5. Predicate Device Information
| Device Name: | Male Latex Condoms |
|---|---|
| 510(k) Number: | K162919 |
| Manufacturer: | Zhejiang Xiangban Latex Products Co., Ltd. |
| Regulatory Class: | Class II |
| Product Code: | HIS (Condom) |
The predicate device has not been subject to a design-related recall.
6. Device Description
The FAMA Male Latex Condoms are single-use, non-sterile condoms made of a natural rubber latex sheath, which covers the penis with a closely fitted membrane. The condoms have a smooth, dotted or ribbed surface and have a straight-walled nipple-end (SWNE) style within specifications listed in ASTM D3492-16, Standard Specification for Rubber Contraceptives (Male Condoms are lubricated with no colorants and fragrances added. The product is made of natural rubber latex, additives are sulfur, zinc oxide, promoter PX, promoter ZDC, antioxidant 264, stabilizer casein, and silicone oil as lubricant. These condoms conform with FDA-recognized standards ASTM D3492-16 and ISO 4074:2015.
4
The device specifications are listed in the table below.
| Parameter | Specification |
|---|---|
| Nominal length | 180 ± 10 mm |
| Nominal width | 53 ± 2 mm |
| Nominal thickness | 0.046 - 0.047 mm (Plain) |
| 0.068 - 0.069 mm (Dotted) | |
| 0.074 - 0.075 mm (Ribbed) | |
| Burst pressure | ≥ 1.0 kPa |
| Burst volume | ≥ 18 dm³ |
| Primary package | |
| material | Aluminum film |
| Lubricant | Silicone oil |
| Dusting | Silicon dioxide |
Table 1: Condom specifications
7. Indications for Use
The FAMA Male Latex Condoms are used for contraception and prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted infections).
8. 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
K220576 | Predicate Device
K162919 | Comparison |
|-------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Trade Name | FAMA Male Latex Condoms | Male Latex Condom | N/A |
| Product Code | HIS | HIS | Same |
| Regulation Number | 21 CFR 884.5300 | 21 CFR 884.5300 | Same |
| Regulation Name | Condom | Condom | Same |
| Indications for Use | The FAMA Male Latex Condoms
are used for contraception and
prophylactic purposes (to help
prevent pregnancy and the
transmission of sexually
transmitted infections). | The Latex Condom for Men is
used for contraception and for
prophylactic purposes (to help
prevent pregnancy and the
transmission of sexually
transmitted diseases). | Same |
| Prescription or Over-
The- Counter-Use | Over-The-Counter-Use | Over-The-Counter-Use | Same |
5
| Materials | Natural Rubber Latex | Natural Rubber Latex | Same |
|---|---|---|---|
| Lubricant Coating | Silicone | Silicone | Same |
| Design | Straight walled with nipple end; | ||
| smooth, ribbed and dotted texture | Straight walled with nipple end; | ||
| smooth, ribbed and dotted texture | Similar | ||
| Length | 180 ± 10 mm | 180 ± 10 mm | Same |
| Width | 53 ± 2 mm | 52 ± 2 mm | Different |
| Thickness | 0.046 - 0.047 mm (Plain) | ||
| 0.068 – 0.069 mm (Dotted) | |||
| 0.074 - 0.075 mm (Ribbed) | 0.06 - 0.07 mm | Different | |
| Burst Pressure | ≥ 1.0 kPa | Not publicly available | N/A |
| Burst Volume | ≥ 18 dm3 | Not publicly available | N/A |
| Sterilization | Non-sterile | Non-sterile | Same |
| Shelf Life | 5 years | 3 years | Different |
The subject and predicate devices have similar indications for use and have the same intended use. The subject device has the same basic technological characteristics of the base material (NRL), shape, texture and silicone lubricant. The differences in technological characteristics (dimensions, shelf-life, minor variation in composition) 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 Testing, Cytotoxicity and Sensitization testing 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" and ISO 10993-1:2009 as follows:
- Cytotoxicity (ISO 10993-5:2009/R 2014) ●
- Sensitization (ISO 10993-10:2010/R 2014)
- Vaginal Irritation (ISO 10993-10:2010/R 2014)
- Acute Systemic Toxicity (ISO 10993-11:2017) ●
The results of this testing demonstrated that the subject devices are non-cytotoxic, non-irritating, non-sensitizing, and not systemically toxic.
Physical Testing
The FAMA Male Latex Condoms were tested at baseline and met all the requirements of ISO 4074:2015 -Natural rubber latex male condoms – Requirements and test methods and ASTM D3492-16 - Standard Specification for Rubber Contraceptives (Male Condoms).
Shelf-Life
The FAMA Male Latex Condoms have a five-year shelf life based on the results of accelerated stability
6
evaluations 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 FAMA Male Latex Condoms are as safe and effective as the predicate device and supports a determination of substantial equivalence.