Male Latex Condoms

K162919 · Zhejiang Xiangban Latex Products Co., Ltd. · HIS · Mar 7, 2017 · Obstetrics/Gynecology

Device Facts

• Record ID: K162919
• Device Name: Male Latex Condoms
• Applicant: Zhejiang Xiangban Latex Products Co., Ltd.
• Product Code: HIS · Obstetrics/Gynecology
• Decision Date: Mar 7, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5300
• Device Class: Class 2

Intended Use

The Latex Condom for Men is used for contraception and for prophylactic purpose (to help prevent pregnancy and the transmission of sexually transmitted diseases).

Device Story

Single-use, non-sterile natural rubber latex sheath; covers penis with closely fitted membrane. Available in smooth, dotted, or ribbed surface textures with straight-walled nipple-end (SWNE) style. Lubricated with silicone oil; dusted with silicon dioxide. Packaged in aluminum film. Used by individuals for contraception and STI prevention. Device conforms to ASTM D3492 and ISO 4074 standards. Provides physical barrier to prevent pregnancy and disease transmission.

Clinical Evidence

Bench testing only. Testing included biocompatibility (ISO 10993-5 cytotoxicity, ISO 10993-10 sensitization, ISO 10993-11 systemic toxicity), performance testing per ASTM D3492-16, and ISO 4074:2015 requirements for natural rubber latex condoms. Shelf-life testing was also conducted.

Technological Characteristics

Material: Natural rubber latex. Design: Straight-walled, nipple-ended. Surface: Smooth, ribbed, or dotted. Lubricant: Silicone oil. Dusting: Silicon dioxide. Dimensions: 180 ± 10 mm length, 52 ± 2 mm width, 0.06-0.07 mm thickness. Standards: ASTM D3492, ISO 4074, ISO 10993. Packaging: Aluminum film, heat-sealed.

Indications for Use

Indicated for men for use as a contraceptive and for prophylactic purposes to help prevent pregnancy and the transmission of sexually transmitted diseases.

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

• M. Dior Brand male latex condom (K083817)

Submission Summary (Full Text)

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Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 7, 2017

Zhejiang Xiangban Latex Products Co., Ltd. % Jonathan Hu Technical Manager Medwheat (Shanghai) Medical Technology Co., Ltd. Yangpu District Liaoyuan East Road Shuangyang First Suite No.33 Room 303 Shanghai 200093 China

Re: K162919 Trade/Device Name: Latex Condom for Men Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: HIS Dated: January 18, 2017 Received: January 27, 2017

Dear Jonathan Hu:

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. 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.

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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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

# Benjamin R. Fisher -S

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### Indications for Use

510(k) Number (if known) K162919

Device Name Latex Condom for Men

Indications for Use (Describe)

The Latex Condom for Men is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases).

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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Image /page/3/Picture/1 description: The image shows a logo with red Chinese characters and the word "XIANG BAN" in red letters below the characters. There are two butterfly-like shapes incorporated into the design of the characters. A registered trademark symbol is located in the upper right corner of the logo.

Date Prepared: February 27, 2017

# 510(k) Summary

[As required by 21 CFR 807.92]

#### 1. Submitter's Information

| Name of Sponsor: | Zhejiang Xiangban Latex Products Co., Ltd. |
|------------------|-----------------------------------------------------------------------------|
| Address: | D288, Huancheng West Road, Beiyuan Industrial Zone,<br>Yiwu, Zhejiang China |
| Contact Name: | Huichao Lou |
| Telephone No.: | 86-18858935588 |
| Fax No.: | 86-579- 85421177 |
| Email Address: | [e-mail] |

#### 2. Correspondent's Information

| Company Name: | Medwheat (Shanghai) Medical Technology Co., Ltd. |
|---------------------|------------------------------------------------------------------------------------------------------|
| Address: | Yangpu District Liaoyuan East Road Shuangyang, First<br>Suite No.33 Room 303, Shanghai, China 200093 |
| Correspondent Name: | Jonathan Hu |
| Telephone No.: | 86-021-65181421 |
| Email Address: | [e-mail] |

## 3. Trade Name, Common Name, Classification

| Trade Name: | Latex Condom for Men |
|-----------------------|------------------------------|
| Common Name: | Condom, Natural Rubber Latex |
| Mode Name: | Plain, Ribbed, Dotted |
| Classification Name: | Condom (21 CFR §884.5300) |
| Product Code: | HIS; condom |
| Classification Panel: | Obstetrics/Gynecology |
| Device Class: | II |

### 4. Identification of Predicate Device(s)

The identified predicates within this submission are as follows:

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Image /page/4/Picture/0 description: The image is completely white and contains no discernible objects, shapes, or patterns. The image appears to be a blank canvas. There are no variations in color or shading. The image is uniform in its whiteness.

Image /page/4/Picture/1 description: The image shows a logo with red Chinese characters and the English transliteration "XIANG BAN" in smaller letters below. There are two butterfly images incorporated into the Chinese characters, and a circled "R" trademark symbol is in the upper right corner. The logo appears to be for a brand named Xiang Ban.

The M. Dior Brand male latex condom cleared by FDA through 510(k) No.K083817 (Decis Date - September 16, 2009). The predicate device has not been subject to a design-related recall.

## 5. Description of the Device

510(k) Submission

The Latex Condom for Men is a single-use, non-sterile condom made of a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. This condom is designed to conform to the standards including ASTM D3492 and ISO 4074. The condoms have either a smooth, dotted, or ribbed surface and have a straight walled nipple-end (SWNE) style within ASTM standard specifications D3492 Table 1 requirements, e.g., minimum length 160 mm, maximum width 54mm, and minimum thickness of 30μM. The device specifications are listed in the table below.

| Parameter | Specification |
|--------------------------|-----------------|
| Nominal length | 180 ± 10 mm |
| Nominal width | 52 ± 2 mm |
| Nominal thickness | 0.06 - 0.07 mm |
| Primary package material | Aluminum film |
| Lubricant | Silicone oil |
| Dusting | Silicon dioxide |

# 6. Intended Use/Indication for Use

The Latex Condom for Men is used for contraception and for prophylactic purpose (to help prevent pregnancy and the transmission of sexually transmitted diseases).

## 7. Technological Characteristics

The 510(k) subject condom products have the same technological characteristics as the predicate condom products. The design is in conformance with ASTM Latex Condom Standard D3492 and the condoms are made of natural rubber latex both are straight-walled, nipple-ended, lubricated condoms and made using the same basic formulations of compounded natural rubber latex.

A comparison of technological characteristics is provided in the following table. The differences in technology do not raise different questions of safety and effectiveness.

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Image /page/5/Picture/0 description: The image shows a logo with red Chinese characters and the word "XIANGBAN" in red letters below. There are two butterflies incorporated into the design of the Chinese characters. A registered trademark symbol is located in the upper right corner of the logo.

#### 510(k) Submission

| Technological<br>Characteristics | Latex Condom for Men | M. Dior Brand<br>(predicate device) - K083817 |
|----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The Latex Condom for Men is<br>used for contraception and for<br>prophylactic purpose (to help<br>prevent pregnancy and the<br>transmission of sexually<br>transmitted diseases). | The condom is used for<br>contraception and for prophylactic<br>purpose (to help prevent pregnancy<br>and the transmission of sexually<br>transmitted diseases). |
| Application | Single Use | Single Use |
| Material | Natural rubber latex | Natural rubber latex |
| Color | Natural | Natural |
| Nominal Length | $180 \pm 10$ mm | 160 mm |
| Nominal Width | $52 \pm 2$ mm | 54 mm |
| Nominal Thickness | 0.06 - 0.07 mm | 0.030 mm |
| Lubricant | Silicone oil | Unknown |
| Dusting | Silicon dioxide | Unknown |
| Packaging Material | Aluminum Film | Aluminum Film |
| Packaging Method | Heat-sealing | Heating-sealing |
| Biocompatibility | ISO10993 Acceptance criteria<br>met | ISO10993 Acceptance criteria met |

# 8. Discussion of Non-clinical Testing

The Latex Condom for Men from Zhejiang Xiangban Latex Products Co., Ltd. has been conducted related non-clinical tests to identify the substantial equivalence from the predicate device. The tests include the concerning of the biocompatibility, performance, and shelf-life, which contains the standards including ISO10993-5:2009 for determining cytotoxicity, ISO10993-10:2010 for determining sensitization, ISO10993-11:2006 for determining systemic toxicity, ASTM D3492-16 Standard Specification for Rubber Contraceptives (Male Condoms), and ISO4074:2015 Natural rubber latex condoms – Requirements and test methods.

#### 9. Conclusion

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#### 510(k) Submission

Image /page/6/Picture/1 description: The image shows a logo with red Chinese characters and the English word "XIANG BAN" in smaller letters below. The characters are stylized and connected by a curved line. There is a registered trademark symbol (®) in the upper right corner of the logo. The logo appears to be for a Chinese brand or company.

In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807, it is concluded that the results of the testing described above demonstrate that the Latex Condom for Men is as safe and effective as the predicate device and support a determination of substantial equivalence.