Banana Gold

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features the department's name in a circular arrangement around a stylized emblem. The emblem consists of three overlapping human profiles facing to the right, with lines suggesting movement or flow. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 August 14, 2015 Hankook Latex Gongup Co., Ltd. Yang Ho Dong CEO Onbix Corporation #821 Samil Plaza, 837-26 Yeuksam-dong Gangnam-gu, Seoul, 135-768, KR Re: K150857 > Trade/Device Name: Banana Gold Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Regulatory Class: Class II Product Code: HIS Dated: May 13, 2015 Received: May 20, 2015 Dear Mr. Ho Dong, 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. 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 {1}------------------------------------------------ related 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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours, # Benjamin R. Fisher -S Benjamin Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K150857 Device Name Banana Gold Indications for Use (Describe) The Banana Gold condom 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) ### 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}------------------------------------------------ ## 510(k) SUMMARY This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR §807.92. | Submitter Information: | HANKOOK LATEX GONGUP CO., LTD.<br>61, Sakju-ro 145beon-gil, Chuncheon-si, Gangwon-do<br>200-160, Republic of Korea | |------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact Person: | Ho Dong, Yang<br>Onbix Corporation<br>#821 Samil Plaza, 837-26 Yeuksam-dong<br>Gangnam-gu, Seoul, 135,768, Korea<br>Tel: *82-2-566-3360 / Fax: *82-2-6280-3360<br>Email: onbix@naver.com | | Date Summary Prepared: | Mar 12, 2015 | #### Device Information: Trade Name(s): Classification Name: Panel: Product code: Banana Gold condom Obstetrics/Gynecology HIS #### Predicate Device Information: K896987 / RUBBER CONDOM (NON-COLORED) #### Device Description: Personal hygienic medical devices for contraception and preventing from sexually transmitted disease. #### Intended Use: The Banana Gold condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases). #### Comparison to Predicate Device(s): This device is equivalent to the predicate devices in its intended use and technological characteristics, including: - * indications for use - * technological characteristics - * performance properties # Summary of the technological characteristics compared to the predicate device new device is substantially equivalent to the predicate device in its technological characteristics stated in the comparison table provided below Comparison table is as follows {4}------------------------------------------------ | | New device<br>Banana Gold | Predicate device<br>Rubber Condom - non-colored | |---------------------|--------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------| | Manufacturer | Hankook Latex Gongup Co., Ltd. | same | | 510(k) Number | K150857 | K896987 | | Product code | HIS | HIS | | Indications for use | Latex condoms are intended to<br>prevent pregnancy, HIV/AIDS, and<br>other sexually transmitted<br>infections | same | | Material | Natural Rubber Latex Drc 60%<br>(high ammonia) | same | | Biocompatibility | Meets the applicable requirement<br>of ISO 10993<br>(biocompatibility was conducted<br>on subject device which<br>included color additive) | Meets the applicable<br>requirement of ISO 10993 | | Shape | Have projected nipple for reservoir<br>(2) Inside equally even<br>(3) Natural latex condom of circular<br>cone type with rim | same | | Type | Ordinary Type | same | | Length | 180 min | 180 ± 10 mm | | Thickness | 0.07 ± 0.02 mm | same | | Lubricant | Linear lydimethylsiloxanepolymer | same | | Color | GOLD | Non-colored | | Scent | none | none | {5}------------------------------------------------ | Latex formulation | Natural rubber latex, sulphur, zinc<br>oxide, antioxidant, ammonia water,<br>tamol, silicone oil, corn starch | same | |-------------------|---------------------------------------------------------------------------------------------------------------|------| | Dusting agent | crosslinked corn-starch | same | #### Non-Clinical Study performance To be in compliance with biocompatibility, biocompatibility study has been applied to the new device in accordance with the following standard - ISO 10993 Biological evaluation of medical devices (biocompatibility was conducted on subject device which included color additive) - ISO 4074:2014 airburst and dimensional specification testing #### Conclusion Based on the information provided in this summary we conclude that Banana Gold is safe and effective and substantially equivalent to the predicate device K896987.