DISPOSABLE THERMOMETER COVERS AND SHEATHS

{0}------------------------------------------------ #### KANG ZE INDUSTRIAL CO., LTD. No. 9 Venture Industry Park, Jane Sandbar, Wanjiang Area, Dongguan, Guangdong, China 523063 # . Section 5 510(k) Summary [As required by 21 CFR 807.92] | 1. Submission Information: | | |------------------------------|-----------------------------------------------------------------------------------| | 510(k) Number: | K112289 | | Date: | Aug 5th, 2011 | | Type of 510(k) Submission: | Traditional | | Basis for 510(k) Submission: | New device | | Submitter/Manufacturer: | KANG ZE INDUSTRIAL CO., LTD. | | | Office Add.: Room 1701, Henan Building, No. 90 Jaffe Road, Wan Chai, HK | | | Factory Add.: No. 9 Venture Industry Park, Jane Sandbar, Wanjiang Area, Dongguan, | | | Guangdong, China 523063 | | Contactor: | Doris Dong | | | [Consultant, from Shanghai CV Technology Co., Ltd.] | | | Add.: Room 1706 Yuesha, No. 128 Songle Rd., Songjiang, Shanghai, China 201600 | | | E-mail: doris_d@126.com | | | Tel: 86 21-31261348 | | | Fax: 86 21-37824346 | | | | | 2. Device Description: | | | Proprietary Name: | Disposable Thermometer Covers and Sheaths | | Common Name: | Disposable Thermometer Covers and Sheaths | | Classification Name: | Clinical electronic thermometer / Clinical mercury thermometer | | Regulation Number: | 880.2910 / 880.2920 | | Product Code: | FLL / FLK | | Device Class: | Class II | | Submission Type: | 510(k) | | Review Panel: | General Hospital | | Indications for use: | The Disposable Thermometer Covers and Sheaths are intended for use as | | | barriers between digital or mercury thermometers and users' rectum or oral | | | cavities to avoid the possible contamination and infection during temperature | | | measuring. These covers and sheaths are non-sterile and intended for single use | | | only. | | Device Description: | The Disposable Thermometer Covers and Sheaths, made of PE and EVA, are | | | used for either oral or rectal measurements for digital or mercury thermometers. | | | The products and packaging are non-sterile and are not made with natural rubber | | | latex. | | | The size may vary to accommodate differences in digital and mercury | | | thermometers. | | | The inner packing material is paper, while the outer packing material is carton. | | | Each outer packing contains 100 pieces of covers and sheaths. | | | | | 3. Substantial Equivalence: | | Detailed comparison data is included in "Section 9 - Substantial Equivalence Discussion" of this 510(k) {1}------------------------------------------------ #### KANG ZE INDUSTRIAL CO., LTD. KANG ZE INDUSTNTAL CO., LTD. No. 9 Venture Industry Park, Jane Sandbar, Wanjiang Area, Dongguan, Guangdong, China 523063 submission | Predicate 510(k) Numbers: | K983406 | K061007 | |---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------| | Marketing clearance date: | October 19th, 1998 | June 14th, 2006 | | Product name: | SaniTherm Thermometer Sheaths, Oral and Rectal, Digital and Mercury | GOOD MEDY Disposable Thermometer Sheaths | | Manufacturer: | Banta Healthcare Products | GOOD MEDY ENTERPRISES LTD | | Differences: | The material and packing specification differ from the Predicate Devices of K983406 and K061007. | | | Similarities: | Same intended use, non-sterile, and similar testing standards. | | | Equivalence conclusion: | The new devices, Disposable Thermometer Covers and Sheaths, are substantially equivalent to the predicate devices: SaniTherm Thermometer Sheaths (K983406) and GOOD MEDY Disposable Thermometer Sheaths (K061007). The devices have same intended use, are non-sterile and latex-free, and passed biocompatibility tests by ISO 10993. Thus the new devices are substantially equivalent to the predicate devices. | | #### 4. Safety and Effectiveness of the device: The Disposable Thermometer Covers and Sheaths were tested and found to meet the standards of ISO 10993-5: 1999: Tests for cytotoxicity: In vitro methods, ISO 10993-10: 2002: Tests for Irritation and Sensitization, ASTM E1104-98(2003): Standard Specification for Clinical Thermometer Probe Covers and Sheaths, IEC 62321 Ed. 1: Electrotechnical products - Determination of levels of six regulated substances (lead, mercury, cadmium, hexavalent chromium, polybrominated biphenyls, polybrominated diphenyl ethers), as well as EPA Method 3546 Microwave extraction. The conclusion drawn from the bench testing and safety testing is that the device is as safe and effective as the predicate device. Furthermore, the device complies with the recognized standards and performs its intended tasks as well as or better than the legally marketed predicate devices. {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a stylized eagle with three lines forming its body and wing. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle. Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 DEC 1 6 2011 Kang ZE Industrial Company, Limited C/O Ms. Doris Dong Manager Shanghai CV Technology Company Limited RM 1706 Yuesha Building No 128 Songle Road Songjiang Area. Shanghai Re: K112289 Trade/Device Name: Disposable Thermometer Covers and Sheaths Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electric Thermometer Regulatory Class: II Product Code: FLL、FLK Dated: November 18, 2011 Received: November 23, 2011 Dear Ms. 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. {3}------------------------------------------------ ### Page 2- Ms. Dong 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 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /yom 1 1 5809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Sincerely yours, Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital. Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ ## Section 4 Indications for Use Statement 510(k) Number (if known); K 112289 Device Name: Disposable Thermometer Covers and Sheaths Indications for Use: The Disposable Thermometer Covers and Sheaths are intended for use as barriers between digital or mercury thermometers and users' rectum or oral cavities to avoid the possible contamination and infection during temperature measuring. These covers and sheaths are non-sterile and intended for single use only. Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use __ √ (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Weihny Crn for Richard Chapman Division Sign Off Division Sign-Off Division of Surgical, Orthopedic, And Restorative Devices 510(k) Number 112289 Page I of l 12