Powder-Free Clear Vinyl Patient Examination Gloves

{0}------------------------------------------------ Image /page/0/Picture/1 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 an emblem featuring a stylized depiction 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 June 27, 2017 Zibo Yue Fan Medical Products Co, Ltd. % Kevin Wang Official Correspondent Intco Medical Industries, Inc. 805 Barrington Avenue Ontario, California 91764 Re: K170735 Trade/Device Name: Powder-Free Clear Vinyl Patient Examination Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: Class I Product Code: LYZ Dated: May 19, 2017 Received: May 26, 2017 Dear Kevin Wang: 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in {1}------------------------------------------------ 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 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, James P. Bertram -S for CDR Lori A. Wiggins, MPT, CLT Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ #### Indications for Use 510(k) Number (if known) K170735 Device Name Powder-free Clear Vinyl Patient Examination Gloves Indications for Use (Describe) A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands or fingers to prevent contamination between patient and examiner. 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) #### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED. 的 FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) 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}------------------------------------------------ Image /page/3/Picture/0 description: The image contains the logo for Zibo Yue Fan Medical Products Co., Ltd. The logo features a blue circle with a white hand inside on the left. To the right of the logo is the company name in bold, black text. There is a black line underneath the company name. No.108 Waniie Road. Yuqiao Industrial Park, Zibo. Shandong, China. Postal Code: 255000 # 510(K) SUMMARY ## K170735 #### Submitter / 510(k) Sponsor Zibo Yue Fan Medical Products Co., Ltd. No.108 Wanjie Road. Yuqiao Industrial Park, Zibo. Shandong, China. Postal Code: 255000 #### Contact Person Kevin Wang Official Correspondent Phone: 909 980 1678 Email: kevinwang@intcous.com #### Summary Preparation Date June 20, 2017 #### Type of 510(k) Submission Traditional #### Trade Name/ Classification Name of Device/Trade Name: Powder Free Clear Vinyl Patient Examination Glove Classification: Patient Examination Glove Product Code: LYZ Product Class: Class I Regulation #: 21 CFR 880.6250 Classification Panel: General Hospital #### Predicate Device Powder-free PVC Vinyl Exam Gloves, Hebei Grandeast Plastic Products Co., Ltd. K142703 #### Device Description Subject device: Powder Free Clear Vinyl Patient Examination Glove Color: Clear Overall Length: 230mm min Width: 94mm min {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for Zibo Yue Fan Medical Products Co., Ltd. The logo includes a blue circle with a white hand inside. The text "Zibo Yue Fan Medical Products Co., Ltd." is written in bold, black letters. No.108 Waniie Road. Yuqiao Industrial Park, Zibo. Shandong, China. Postal Code: 255000 Palm Thickness: 0.09 mm min Fingertip Thickness: 0.086 mm min #### Non clinical performance tests Significant physical and performance characteristics of the device: glove production is based on ASTM-D-5250-06. All testing meets requirements for Physical and Dimensions Testing conducted on gloves, Inspection Level S-2, AOL 2.5. Subject Powder Free Clear Vinyl Patient Examination Glove do not contain any USP powder per the results of testing conducted on the gloves. The residual powder testing is conducted per standards of ASTM D-6124-06, which demonstrates that the powder free glove is less than 2mg/pc. Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Powder-Free Vinyl Patient Examination Glove, 80LYZ, and meets all requirement of ASTM Standard D5250-06. Overall Length: 230mm min Width: 94mm min Palm Thickness: 0.09 mm min Fingertip Thickness: 0.086 mm min Tensile Strength (Mpa) Before aging 15Mpa min After aging 13Mpa min Ultimate Elongations Before aging 495% min After aging 415% min #### Indications for Use A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands or finger to prevent contamination between patient and examiner. {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for Zibo Yue Fan Medical Products Co., Ltd. The logo features a blue circle with a white hand inside on the left. The company name is written in bold black letters to the right of the logo. There is a black line underneath the company name. No.108 Wanjie Road. Yuqiao Industrial Park, Zibo. Shandong, China. Postal Code: 255000 | Device<br>Characteristics | Proposed Device | Predict Device | Comparison<br>Conclusion | |--------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------| | Product Name | Powder Free Clear Vinyl<br>Patient Examination Glove | Powder free PVC Vinyl<br>Exam Gloves | | | 510(k) Number | K170735 | K142703 | | | Product Owner | Zibo Yue Fan Medical<br>Products Co., Ltd. | Hebei Grandeast Plastic<br>Products Co., Ltd. | | | Product Code | LYZ | LYZ | Same | | Intended Use | 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 | 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 | Same | | Regulation Number | 21 CFR 880.6250 | 21 CFR 880.6250 | Same | | Sizes | Small<br>Medium<br>Large<br>Extra-Large | Small<br>Medium<br>Large<br>Extra-Large | Same | | Length on Large<br>Size | Average over 232.23mm | Average over 230mm | Similar | | Width of Palm on<br>Large Size | Average 95mm | Average 95mm | Similar | | Palm Thickness | Average 0.095 mm | Average 0.095 mm | Similar | | Fingertip<br>Thickness | Average 0.09 mm | Average 0.09 mm | Similar | | Residual Powder | According to ASTM<br>D6124-06 Standard Test<br>Method for Residual<br>Powder on Medical gloves<br>for the determination of<br>residual powder content.<br>Testing result indicates the<br>weight of all types of<br>residual or powder on<br>finished powder-free<br>gloves as < 2 mg per glove<br>and there is no defect glove | According to ASTM<br>D6124-06 Standard Test<br>Method for Residual<br>Powder on Medical gloves<br>for the determination of<br>residual powder content.<br>Testing result indicates the<br>weight of all types of<br>residual or powder on<br>finished powder-free<br>gloves as < 2 mg per glove<br>and there is no defect glove | Similar | | | found according to ASTM<br>D6124-06. | found according to ASTM<br>D6124-06. | | | Pinhole Results | According to ASTM<br>D5151-06, Testing result<br>indicates pinhole were<br>found less than two pieces<br>gloves out of 125 pieces<br>gloves. AQL 2.5 is met. | According to ASTM<br>D5151-06, Testing result<br>indicates pinhole were<br>found less than two pieces<br>gloves out of 125 pieces<br>gloves. AQL 2.5 is met. | Similar | | Biocompatibility<br>Result: Primary<br>Skin Irritation | Under the conditions of the<br>study, the subject device is<br>not an irritant | Under the conditions of the<br>study, the subject device is<br>not an irritant | Similar | | Before Aging:<br>Tensile<br>Strength(Mpa) and<br>Ultimate<br>Elongations | Average Tensile Strength<br>(Mpa): 16.96<br>Average Ultimate<br>Elongations: 519% | Average Tensile Strength<br>(Mpa): 16.96<br>Average Ultimate<br>Elongations: 519% | Similar | | After Aging:<br>Tensile<br>Strength(Mpa) and<br>Ultimate<br>Elongations | Average Tensile Strength<br>(Mpa): 14.92<br>Average Ultimate<br>Elongations: 480% | Average Tensile Strength<br>(Mpa): 14.92<br>Average Ultimate<br>Elongations: 480% | Similar | | Dermal<br>Sensitization | Under the conditions of the<br>study, the subject device is<br>not an sensitizer | Under the conditions of the<br>study, the subject device is<br>not an sensitizer | Similar | #### TABLE 1: COMPARISON OF PROPOSED AND PREDICATE DEVICES {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows a blue circular sign with a white hand in the center. The hand is depicted with fingers pointing upwards and a wrist or cuff at the bottom. The sign is likely used to indicate a warning or instruction related to hand safety or hygiene. Zibo Yue Fan Medical Products Co., Ltd. #### No.108 Wanjie Road. Yuqiao Industrial Park, Zibo. Shandong, China. Postal Code: 255000 ### Conclusion The conclusions drawn from the nonclinical and clinical tests that demonstrate that the subject device is as safe, as effective, and performs as well as the predict device.