LINSHI NITRILE DISPOSABLE EXAM GLOVES, POWDER-FREE

{0}------------------------------------------------ # 5.0 510(k) Summary K123488 : | Submitter /<br>Manufacturer /<br>510(k) Owner: | Puyang Linshi Medical Supplies Co., Ltd. Industrial Park, Puyang County<br>(East of Changsheng Road)<br>Puyang City, 457100 Henan Province, China Telephone: 0086-393-333-<br>1066<br>Fax: 0086-393-333-9566<br>Manufacturer Contact Person<br>Mr. Frank Yanhai Lv<br>Assistant of the President<br>lvyanhai@linshichem.com | |------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Application<br>Correspondent: | Ms. Laura Weng<br>Vice President, Operations<br>lauraw@usalinshi.com<br>Linshi Chemical America Co., Ltd.<br>17800 Castleton St. Suite# 328<br>City of Industry, CA 91748<br>Telephone: 626-581-3030<br>Fax: 626-581-3035 | | Date Prepared: | January 23, 2013 | | Trade Name: | Linshi Health Nitrile Disposable Exam Gloves, Powder-Free | | Common<br>Name: | Exam Gloves | | Classification: | Class I<br>Patient Examination Glove<br>21 CFR 880.6250 | | Product Code: | LZA | | Predicate<br>Device(s): | The subject device is equivalent to the following device:<br>K121947<br>ETS Blue Powder Free Nitrile Patient Examination Glove | | Device<br>Description: | Non-sterile, single-use, powder-free nitrile patient examination gloves<br>(blue color), that meet requirements of ASTM D6139-10. | | Intended Use: | A powder-free patient examination glove is a disposable device intended<br>for medical purposes that is worn on the examiner's hand or finger to<br>prevent contamination between patient and examiner. | {1}------------------------------------------------ | mmary of<br>technological<br>Laracteristics | The powder-free blue nitrile examination glove is substantially equivale<br>to the predicate device with regard to physical characteristics, design,<br>product features, and intended use. | | | |---------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Feature | ETS Blue Powder Free<br>Nitrile Exam Gloves<br>K121947<br>Predicate Device | Linshi Health Nitrile<br>Disposable Exam Gloves,<br>Powder-Free<br>Subject Device | | | Classification | Class I<br>Patient Examination Glove | Same | | | Product Code | LZA | Same | | | Regulation | 21 CFR 880.6250 | Same | | | Indications for<br>Use | The examination glove is a<br>disposable device intended<br>for medical purposes that is<br>worn on the examiner's hand<br>or finger to prevent<br>contamination between<br>patient and examiner. | A powder-free patient<br>examination glove is a<br>disposable device intended<br>for medical purposes that is<br>worn on the examiner's<br>hand or finger to prevent<br>contamination between<br>patient and examiner. | | | Description | Non-sterile, powder free,<br>examination gloves made of<br>nitrile and colored blue. | Same | | | Packaging | Non-sterile gloves are<br>provided in dispenser boxes. | Same | | | Sterilization | Non-Sterile | Same | | | Single Use | Yes | Same | | | Ambidextrous | Yes | Same | | | Dimensions | Meets ASTM D6319-10 | Same | | | Tensile Strength | Meets ASTM D6319-10 | Same | | | Ultimate<br>Elongation | Meets ASTM D6319-10 | Same | | | Freedom from<br>Pinholes | Meets ASTM D5151-06 and<br>ASTM D6319-10 | Same | | | Residual Powder | Meets ASTM D6124-06 | Same | | | Biocompatibility | Passes Primary Skin Irritation<br>in Rabbits | Same | | | | Passes Closed Patch<br>Sensitization in Guinea Pigs | Same | Puyang Linshi Health Co., Ltd. considers the Linshi Health Nitrile Conclusion: Disposable Exam Gloves, Powder-Free to be equivalent to the predicate device listed above. This conclusion is based upon the devices' similarities in principles of operation, technology, materials and indications for use. Sum Tec Cha K123488 {2}------------------------------------------------ Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a snake entwined around it, and three horizontal bars. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus symbol. ### DEPARTMENT OF HEALTH & HUMAN SERVICES Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 ### February 8, 2013 Puyang Linshi Health Company, Limited C/O Ms. Laura Weng Vice President, Operations Linshi Chemical America Company, Limited 17800 Castleton Street, Suite 328 CITY OF INDUSTRY CA 91748 Re: K123488 Trade/Device Name: Powder-Free Nitrile Gloves, Blue Color Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: LZA Product Code: I Dated: January 23, 2013 Received: January 24, 2013 ### Dear Ms. Weng: 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. Weng 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.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, hor The Harshitaid Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health #### Enclosure {4}------------------------------------------------ # K123488 #### Indications for Use Statement 4.0 ### Device Name: Powder-Free Nitrile Examination Gloves, Blue Color ## Indications for Use: A powder-free patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. Prescription Use (21 CFR 801 Subpart D) ( AND/OR Over-The-Counter Use X (21 CFR 801 Subpart C) # (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Elizabeth F. Claverie | | 2013.02.07 16:55:51 -05'00' | |--|-----------------------------| |--|-----------------------------| (Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices | 510(k) Number: | K123488 | |----------------|---------| |----------------|---------|