FAMA Male Latex Condoms – Aqueous Lubricant (Ultra-thin);FAMA Male Latex Condoms – Aqueous Lubricant (Plain);FAMA Male Latex Condoms – Aqueous Lubricant (Ribbed);FAMA Male Latex Condoms – Aqueous Lubricant (Dotted);FAMA Male Latex Condoms – Aqueous Lubricant (Non-regular Shaped);MO Male Latex Condoms – Aqueous Lubricant (Ultra-thin);MO Male Latex Condoms – Aqueous Lubricant (Plain);MO Male Latex Condoms – Aqueous Lubricant (Ribbed);MO Male Latex Condoms – Aqueous Lubricant (Dotted);MO
Device Facts
| Record ID | K262108 |
|---|---|
| Device Name | FAMA Male Latex Condoms – Aqueous Lubricant (Ultra-thin);FAMA Male Latex Condoms – Aqueous Lubricant (Plain);FAMA Male Latex Condoms – Aqueous Lubricant (Ribbed);FAMA Male Latex Condoms – Aqueous Lubricant (Dotted);FAMA Male Latex Condoms – Aqueous Lubricant (Non-regular Shaped);MO Male Latex Condoms – Aqueous Lubricant (Ultra-thin);MO Male Latex Condoms – Aqueous Lubricant (Plain);MO Male Latex Condoms – Aqueous Lubricant (Ribbed);MO Male Latex Condoms – Aqueous Lubricant (Dotted);MO |
| Applicant | Shanghai Personage Hygiene Products Co., Ltd. |
| Product Code | HIS · Obstetrics/Gynecology |
| Decision Date | Sep 21, 2026 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 884.5300 |
| Device Class | Class 2 |
Indications for Use
The FAMA/MO/Mingliu Male Natural Rubber Latex Condoms – Aqueous Lubricant are used for contraception and prophylactic purposes (to help prevent pregnancy and sexually transmitted infections).
Device Story
Single-use, non-sterile male condoms; natural rubber latex sheath; straight-walled or contoured profiles with nipple-ended geometry; available in smooth, dotted, or ribbed surfaces. Device functions as a physical barrier to prevent pregnancy and STIs. Used by consumers in home or private settings. Lubricated with aqueous lubricant; dusted with silicon dioxide. Packaged in polypropylene blister trays with aluminum film lidding. Performance conforms to ISO 4074:2015 and ASTM D3492-16 standards.
Clinical Evidence
No clinical data. Bench testing only. Performance testing conducted per ASTM D3492-16 and ISO 4074:2015. Biocompatibility testing performed 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). Accelerated stability testing supports a five-year shelf life.
Technological Characteristics
Material: Natural rubber latex. Lubricant: Aqueous. Dusting: Silicon dioxide. Dimensions: Length 185±10mm; Width 49-56mm; Thickness 0.045-0.085mm. Packaging: Polypropylene base tray with aluminum film lidding. Standards: ISO 4074:2015, ASTM D3492-16. Shelf life: 5 years.
Indications for Use
Indicated for contraception and prophylactic purposes to help prevent pregnancy and sexually transmitted infections 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
- FAMA Male Latex Condoms (K220576)
Submission Summary (Full Text)
{0}
September 21, 2026
Shanghai Personage Hygiene Products Co., Ltd.
% Vincent Zhou
Regulatory Affairs Manager
Medwheat, Inc.
7900 International Dr. #300
Bloomington, Minnesota 55425
Re: K262108
Trade/Device Name: FAMA/MO/Mingliu Male Natural Rubber Latex Condoms –
Aqueous Lubricant
Regulation Number: 21 CFR 884.5300
Regulation Name: Condom
Regulatory Class: II
Product Code: HIS
Dated: June 23, 2026
Received: June 23, 2026
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 (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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K262108 - Vincent Zhou
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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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K262108 - Vincent Zhou
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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 (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
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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)
K262108
Device Name
FAMA/MO/Mingliu Male Natural Rubber Latex Condoms – Aqueous Lubricant
Indications for Use (Describe)
The FAMA/MO/Mingliu Male Natural Rubber Latex Condoms – Aqueous Lubricant are used for contraception and prophylactic purposes (to help prevent pregnancy and 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.
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# *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*
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FORM FDA 3881 (6/20)
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PSC Publishing Services (301) 443-6740
EF
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K262108
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510(k) Submission
## 510(k) Summary – K262108
[As required by 21 CFR 807.92]
### 1. Submitter Information
Name of Sponsor: Shanghai Personage Hygiene Products Co., Ltd.
Address: 88 Tianchen Road, Qingpu District, Shanghai,
201700, China
Contact Name: Zhengjun Zhu
Telephone No.: 86-021-69214099
Fax No.: 86-021-69214100
Email Address: information@shbon.com
Date Prepared: September 18, 2026
### 2. Correspondent Information
Company Name: Medwheat Inc.
Correspondent Name: Vincent Zhou
Telephone No.: 001-612-806-2995
Email Address: us.agent@medwheat.com
### 3. Device Information
Device Trade Name: FAMA/MO/Mingliu Male Natural Rubber Latex
Condoms – Aqueous Lubricant
Common Name: Natural rubber latex male condoms
Regulation Number: 21 CFR 884.5300
Regulation Name: Condom
Product Code: HIS (Condom)
Device Class: II
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K262108
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510(k) Submission
### 4. Identification of Predicate Device
K220576: FAMA Male Latex Condoms
The predicate device has not been subject to a design related recall.
### 5. Description of the Device
FAMA/MO/Mingliu Male Natural Rubber Latex Condoms – Aqueous Lubricant are single-use, non-sterile male condoms. Each condom consists of a natural rubber latex sheath designed to form a closely fitted membrane over the penis. Available with smooth, dotted, or ribbed surfaces, the condoms feature straight-walled or contoured profiles with nipple-ended geometry. The product line is engineered and manufactured to conform fully with international and national performance standards, including ISO 4074:2015 and ASTM D3492-16.
| Parameter | Specification |
| --- | --- |
| Nominal length | 185 ± 10 mm |
| Nominal width | 49 ± 2 mm (Ultra-thin) 53 ± 2 mm (Ultra-thin; Plain; Dotted; Ribbed; Non-regular Shaped) 56 ± 2 mm (Ultra-thin; Plain; Non-regular Shaped) |
| Nominal thickness | 0.045 - 0.055 mm (Ultra-thin) 0.055 – 0.075 mm (Plain) 0.060 – 0.080 mm (Dotted) 0.055 – 0.075 mm (Ribbed) 0.060 – 0.085 mm (Non-regular Shaped) |
| Primary package material | Blister Packaging (Polypropylene (PP) base tray with an aluminium film sealing lid) |
| Lubricant | Aqueous - 1600±100mg / 1200±100mg (HA+) - 800±100mg (HA) |
| Dusting | Silicon dioxide |
### 6. Indications for Use
The FAMA/MO/Mingliu Male Natural Rubber Latex Condoms – Aqueous Lubricant are used for contraception and prophylactic purposes (to help prevent pregnancy and sexually transmitted infections).
### 7. Comparison of Intended Use and Technological Characteristics
The table below compares the intended use and technological characteristics of the subject device and predicate device.
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K262108
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# 510(k) Submission
| Technical Characteristics | FAMA/MO/Mingliu Male Natural Rubber Latex Condom – Aqueous Lubricant | | FAMA Male Latex Condom – Silicone Oil (predicate device) – K220576 | |
| --- | --- | --- | --- | --- |
| **Intended Use** | The FAMA/MO/Mingliu Male Natural Rubber Latex Condoms – Aqueous Lubricant are used for contraception and prophylactic purposes (to help prevent pregnancy and sexually transmitted diseases). | | The FAMA Male Latex Condoms are used for contraception and prophylactic purposes (to help prevent pregnancy and sexually transmitted diseases). | |
| **Application** | Single use | | Single use | |
| **Material** | Natural rubber latex | | Natural rubber latex | |
| **Color** | Natural | | Natural | |
| **Nominal Length** | 185 ± 10 mm | | 180 ± 10 mm | |
| **Nominal Width** | 49 ± 2 mm | Ultra-thin | 53 ± 2 mm | Plain; Dotted; Ribbed; |
| | 53 ± 2 mm | Ultral-thin; Plain; Dotted; Ribbed; Non-regular Shaped | | |
| | 56 ± 2 mm | Ultral Thin; Plain; Non-regular Shaped | | |
| **Nominal Thickness** | 0.045-0.055 mm | Ultral Thin | | |
| | 0.055-0.075 mm | Plain | 0.046-0.047 mm | Plain |
| | 0.060-0.080 mm | Dotted | 0.068-0.069 mm | Dotted |
| | 0.055-0.075 mm | Ribbed | 0.074-0.075 mm | Ribbed |
| | 0.055-0.085 mm | Non-regular Shaped | | |
| **Lubricant** | Aqueous | | Silicone oil | |
| | 1600±100mg / 1200±100mg (HA+) | 800±100mg (HA) | 300 – 600 mg | |
| **Dusting** | Silicon dioxide | | Silicon dioxide | |
| **Packaging Material** | Blister Packaging (PP base with Aluminum Film Lidding) | | Aluminum Film | |
| **Packaging Method** | Heat-sealing | | Heat-sealing | |
| **Shelf Life** | Five years | | Five years | |
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K262108
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510(k) Submission
The subject and predicate device have the same intended use – for contraception and prophylactic purposes. The subject device has the same basic technological characteristics of the predicate device, such as the base material (NRL), texture, length, shelf life and packaging. The difference in technological characteristics (dimensions, lubricant, shape) do not raise different questions of safety and effectiveness. The differences can be evaluated through performance testing.
### 8. Summary of Non-Clinical Performance Testing
#### Performance Testing
FAMA/MO/Mingliu Male Natural Rubber Latex Condoms – Aqueous Lubricant from Shanghai Personage Hygiene Products Co., Ltd. was tested and met the requirements 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
FAMA/MO/Mingliu Male Natural Rubber Latex Condoms – Aqueous Lubricant has a five-year shelf life based on the results of accelerated stability evaluations conducted as required in 21 CFR 801.435. All samples met predefined acceptance criteria.
#### Biocompatibility
Biocompatibility evaluations were performed on the FAMA/MO/Mingliu Male Natural Rubber Latex Condoms – Aqueous Lubrican 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 (ISO10993-5:2009)
- Sensitization (ISO10993-10:2021)
- Vaginal irritation (ISO10993-23:2021)
- Acute systemic toxicity (ISO10993-11:2017)
The results of testing demonstrate that the subject device is non-cytotoxic, non sensitizing, non-irritating, and not acutely systemically toxic.
### 10. Conclusion
The results of performance testing above demonstrates that FAMA/MO/Mingliu Male Natural Rubber Latex Condoms – Aqueous Lubricant is as safe and effective as the predicate device and supports a determination of substantial equivalence.
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