Single-use medical poly (vinyl chloride) examination glove (Clear, Non-Colored)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. September 21, 2018 Hebei Titans Hongsen Medical Technology Co., LTD. Ray Wang General Manager Beijing Believe-Med Technology Service Co., Ltd. Rm.912, Building #15, XiYueHui, No.5 YiHe North Rd., FangShan District Beijing, 102401 Cn Re: K182043 Trade/Device Name: Single-use medical poly (vinyl chloride) examination glove (Clear, Non-Colored) Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: Class I Product Code: LYZ Dated: July 23, 2018 Received: July 30, 2018 Dear Ray 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. {1}------------------------------------------------ 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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, For Tina Kiang, Ph.D. 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}------------------------------------------------ DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration # Indications for Use 510(k) Number (if known) K182043 Device Name Single-use medical poly (vinyl chloride) examination glove (Clear, Non-Colored) Indications for Use (Describe) The Single-use medical poly (vinyl chloride) examination glove (Clear, Non-Colored) is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner. 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 Druq 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." Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below. EF PSC Publishing Services (301) 443-6740 {3}------------------------------------------------ # 510(k) Summary This 510(k) Summary is being submitted in accordance with Title 21, CFR Section 807.92. The assigned 510(k) Number: K182043 - 1. Date of Preparation:2018/08/18 - 2. Sponsor Identification # HEBEI TITANS HONGSEN MEDICAL TECHNOLOGY CO., LTD. EASTERN INDUSTRIAL ZONE, NANGONG CITY, HEBEI PROVINCE, CHINA Contact Person: Mr. ShaoZhang Nan Tel: +86-0319-7295820 Fax: +86-0319-7295801 Email: nanshaozhang@163.com - 3. Designated Submission Correspondent Mr. Ray Wang # Beijing Believe-Med Technology Service Co., Ltd. Tel: +86-18910677558, Fax: +86-10-56335780 Email: Ray.Wang(@believe-med.com {4}------------------------------------------------ #### 4. Identification of Proposed Device Trade Name: Single-use medical poly (vinyl chloride) examination glove (Clear, Non-Colored) Common Name: Vinyl Patient Examination Gloves (Powder Free) Model(s): XS S M L XL Regulatory Information Classification Name: Vinyl Patient Examination Gloves (Powder Free) Classification:1 Product Code: LYZ Regulation Number: 21 CFR 880.6250 Review Panel: General Hospital Indication for use Statement: The Single-use medical poly (vinyl chloride) examination glove (Clear, Non-Colored) is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner. - 5. Device Description The proposed device is Powder Free Vinyl Patient Examination Gloves. The proposed device is clear, non-colored. The design of proposed device is addressing the standards as ASTM D6124, ASTM D5151, and ASTM D5250. The proposed device is non-sterile. #### 6. Identification of Predicate Device(s) Predicate Device K163168 Vinyl Patient Examination Gloves (White, Blue, Yellow) Hebei Hongtai Plastic Products Company Limited K180849 Vinyl Examination Glove (Clear, Non-Colored) HUIFU TRADING CO., LTD. {5}------------------------------------------------ | ITEM | Proposed Device (K182043) | Predicate Device (K163168) | Predicate Device (K180849) | Remark | |-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------| | Product Code | LYZ | LYZ | LYZ | SAME | | Regulation No. | 21 CFR 880.6250 | 21 CFR 880.6250 | 21 CFR 880.6250 | SAME | | Class | I | I | I | SAME | | Intended Use | The Single-use medical poly<br>(vinyl chloride) examination<br>glove (Clear, Non-Colored) is<br>a disposable device intended<br>for medical purposes that is<br>worn on the examiner's hands<br>to prevent contamination<br>between patient and examiner. | The Vinyl Examination Glove<br>(White, Blue, or Yellow) is a<br>disposable device intended for<br>medical purposes that is worn on<br>the examiner's hands to prevent<br>contamination between patient<br>and examiner. | The Vinyl Patient<br>Examination Glove (Clear,<br>Non-Colored) is a disposable<br>device intended for medical<br>purposes that is worn on the<br>examiner's hands to prevent<br>contamination between patient<br>and examiner. | SAME | | Powdered or<br>Powered free | Powdered free | Powdered free | Powdered free | SAME | | Design Feature | ambidextrous | ambidextrous | ambidextrous | SAME | | Surface Feature | Smooth | Smooth | Smooth | SAME | | Labeling<br>Information | Single-use indication, powder<br>free, device color, device<br>name, glove size and quantity,<br>Vinyl Examination Gloves,<br>Non-Sterile | Single-use indication, powder<br>free, device color, device name,<br>glove size and quantity, Vinyl<br>Examination Gloves, Non-Sterile | Single-use indication, powder<br>free, device color, device<br>name, glove size and quantity,<br>Vinyl Examination Gloves,<br>Non-Sterile | SAME | #### 7. Technological Comparison Table 1 General Comparison {6}------------------------------------------------ | | Designation | Size | | | | | Tolerance | |----------------------------|----------------|------|-----|-----|-----|-----|-----------| | | | XS | S | M | L | XL | | | Proposed Device (K182043) | Length, mm | 240 | 240 | 240 | 240 | 240 | min | | | Width, mm | 80 | 85 | 95 | 105 | 115 | $\pm 5$ | | | Thickness, mm: | | | | | | | | | Finger | 0.07 | | | | | min | | | Palm | 0.08 | | | | | min | | Predicate Device (K163168) | Designation | XS | S | M | L | XL | Tolerance | | | Length, mm | 230 | 230 | 235 | 245 | 245 | min | | | Width, mm | 80 | 85 | 95 | 105 | 115 | $\pm 5$ | | | Thickness, mm: | | | | | | | | | Finger | 0.05 | | | | | min | | | Palm | 0.08 | | | | | min | | Predicate Device (K180849) | Designation | | S | M | L | XL | Tolerance | | | Length, mm | | 230 | 235 | 245 | 245 | min | | | Width, mm | | 85 | 95 | 105 | 115 | $\pm 5$ | | | Thickness, mm: | | | | | | | | | Finger | 0.05 | | | | | min | | | Palm | 0.08 | | | | | min | | Remark | Analysis 1 | | | | | | | # Table 2 Device Dimensions Comparison {7}------------------------------------------------ | ITEM | Proposed Device<br>(K182043) | Predicate Device<br>(K163168) | Predicate Device<br>(K180849) | Remark | | |------------------------|----------------------------------------------------------------------------------|------------------------------------|----------------------------------------------------------------------------------|----------------------------------------------------------------------------------|------------| | Colorant | Clear, Non-Colored | White, Blue,<br>Yellow | Clear,<br>Non-Colored | Analysis 2 | | | Physical<br>Properties | Before<br>Aging | Tensile<br>Strength<br>15 MPa, min | 15 MPa, min | 15 MPa, min | Analysis 3 | | | Ultimate<br>Elongation | 350 % min | 380 % min | 380 % min | | | | After<br>Aging | Tensile<br>Strength<br>15 MPa, min | 15 MPa, min | 15 MPa, min | | | | Ultimate<br>Elongation | 350 % min | 380 % min | 380 % min | | | | Comply with ASTM D5250 | | Comply with<br>ASTM D5250 | Comply with<br>ASTM D5250 | SAME | | Freedom from Holes | Be free from holes<br>when tested in<br>accordance with<br>ASTM D5151<br>AQL=1.5 | | Be free from holes<br>when tested in<br>accordance with<br>ASTM D5151<br>AQL=1.5 | Be free from holes<br>when tested in<br>accordance with<br>ASTM D5151<br>AQL=1.5 | SAME | | Powder Content | 0.33 mg | | Meet the<br>requirements of<br>ASTM 5250 | Meet the<br>requirements of<br>ASTM 5250 | SAME | Table 3 Performance Comparison # Table 4 Safety Comparison | ITEM | Proposed Device (K182043) | Predicate Device<br>(K163168) | Predicate Device<br>(K180849) | Remark | | |--------------------|---------------------------|--------------------------------------------------------------------------------------|-------------------------------|-----------------------------|------| | Material | Vinyl | Vinyl | Vinyl | SAME | | | Biocompatibility | Irritation | Under the conditions of the<br>study, not an irritant | Comply with ISO<br>10993-10 | Comply with ISO<br>10993-10 | SAME | | | Sensitization | Under conditions of the study,<br>not a sensitizer. | Comply with ISO<br>10993-10 | Comply with ISO<br>10993-10 | SAME | | | Cytotoxicity | Under conditions of the study,<br>did not show potential toxicity<br>to L-929 cells. | / | Comply with ISO<br>10993-5 | SAME | | Label and Labeling | | Meet FDA's Requirements | Meet FDA's<br>Requirements | Meet FDA's<br>Requirements | SAME | # Analysis 1: The proposed device has different Length to the predicate device, but all proposed devices are conducted the test according ASTM 5250, the test results shown that the Length of proposed device meet the {8}------------------------------------------------ ### requirements of standard. ### Analysis 2: The proposed device has different color to the predicate device, but all proposed devices are conducted the test according ISO 10993-5 and ISO 10993-10 for Irritation and Cytotoxicity, and other non-clinical bench test. The test results shown that the performance of proposed device meet the requirements of standard and no potential biocompatibility issues. So, the different color would not effects the safety and effectiveness of proposed device. # Analysis 3: The proposed device has different Ultimate Elongation to the predicate device, but all proposed devices are conducted the test according ASTM 5250, the test results shown that the Ultimate Elongation of proposed device meet the requirements of standard. #### 8. Non-Clinical Test Conclusion Non clinical tests were conducted to verify that the proposed device met all design specifications. The test results demonstrated that the proposed device complies with the following standards: - > ISO 10993-10:2010 Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization. - ISO 10993-5:2009 Biological Evaluation Of Medical Devices Part 5: Tests For In Vitro A Cytotoxicity - > ASTM D6124-06 (Reaffirmation 2017), Standard Test Method for Residual Powder on Medical Gloves - ASTM D5151-06 (Reapproved 2015), Standard Test Method for Detection of Holes in Medical > Gloves. - > ASTM D5250-06 (Reapproved 2015), Standard Specification for Poly(vinyl chloride) Gloves for Medical Application. - > ISO 2859-1:1999, "Sampling Procedures for Inspection by Attributes - Part I: Sampling Plans Indexed by Acceptable Quality Level (AQL) for Lot-by-Lot Inspection. - Clinical Test Conclusion 9. Clinical testing is not needed for this device. - 10. Conclusion The conclusions drawn from the nonclinical tests demonstrate that the proposed device is as safe, as effective, and performs as well as or better than the legally marketed predicate device.