Vinyl Examination Glove (Clear, Non-Colored)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left and consists of a stylized emblem. The FDA logo is on the right and includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. June 11, 2018 Huifu Trading 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 China Re: K180849 Trade/Device Name: Vinyl Examination Glove (Clear, Non-Colored) Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: Class I Product Code: LYZ Dated: March 30, 2018 Received: April 2, 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. 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 {1}------------------------------------------------ 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); 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. 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. 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, Geeta K. Pamidimukkala -S 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) K180849 Device Name Vinyl Examination Glove (Clear, Non-Colored) Indications for Use (Describe) The Vinyl 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. 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EF {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: K180849 - 1. Date of Preparation:2018/06/04 - 2. Sponsor Identification HUIFU TRADING CO., LTD. NORTH, SHANGHAI ROAD, ZHANGDIAN DISTRICT, ZIBO CITY, CHINA 255000 Contact Person: Kangkang Wang Position:Sales Manager Tel: +86-533-3819144 Fax: +86-533-3819144 Email: victor821016@126.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: Vinyl Examination Glove (Clear, Non-Colored) Common Name: Vinyl Patient Examination Gloves (Powder Free) Model(s): 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 Vinyl 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. - Device Description న. 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. - Identification of Predicate Device(s) 6. Predicate Device K163168 Vinyl Patient Examination Gloves (White, Blue, Yellow) Hebei Hongtai Plastic Products Company Limited {5}------------------------------------------------ | 7. | Technological Comparison | |----|--------------------------| |----|--------------------------| | ITEM | Proposed Device | Predicate Device (K163168) | Remark | |-----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------| | Product Code | LYZ | LYZ | SAME | | Regulation No. | 21 CFR 880.6250 | 21 CFR 880.6250 | SAME | | Class | I | I | SAME | | Intended Use | The Vinyl Patient Examination Glove<br>(Clear, Non-Colored) is a disposable<br>device intended for medical purposes that<br>is worn on the examiner's hands to prevent<br>contamination between patient and<br>examiner. | The Vinyl Examination Glove (White,<br>Blue, or Yellow) is a disposable device<br>intended for medical purposes that is worn<br>on the examiner's hands to prevent<br>contamination between patient and<br>examiner. | SIMILAR | | Powdered or<br>Powered free | Powdered free | Powdered free | SAME | | Design Feature | ambidextrous | ambidextrous | SAME | | Surface Feature | Smooth | Smooth | SAME | | Labeling<br>Information | Single-use indication, powder free, device<br>color, device name, glove size and quantity,<br>Vinyl Examination Gloves, Non-Sterile | Single-use indication, powder free, device<br>color, device name, glove size and quantity,<br>Vinyl Examination Gloves, Non-Sterile | SAME | Table 1 General Comparison Table 2 Device Dimensions Comparison | | | Size | | | | | | |----------------------------|----------------|------|-----|-----|-----|-----------|-----------| | | Designation | XS | S | M | L | XL | Tolerance | | | Length, mm | 230 | 230 | 235 | 245 | 245 | min | | Predicate Device (K163168) | Width, mm | 80 | 85 | 95 | 105 | 115 | $\pm$ 5 | | | Thickness, mm: | | | | | | | | | Finger | 0.05 | | | | | min | | | Palm | 0.08 | | | | | min | | | | Size | | | | Tolerance | | | | Designation | S | M | L | XL | | | | | Length, mm | 230 | 235 | 245 | 245 | | min | | Proposed Device | Width, mm | 85 | 95 | 105 | 115 | | $\pm$ 5 | | | Thickness, mm: | | | | | | | | | Finger | 0.05 | | | | | min | | | Palm | 0.08 | | | | | min | | Remark | SAME | | | | | | | # Table 3 Performance Comparison | ITEM | Proposed Device | Predicate Device (K163168) | Remark | |----------|--------------------|----------------------------|------------| | Colorant | Clear, Non-Colored | White, Blue, Yellow | Analysis 1 | {6}------------------------------------------------ | Physical<br>Properties | | Tensile<br>Strength<br>Before | 15 MPa, min | 15 MPa, min | | | |------------------------|--------------------|-------------------------------|------------------------|----------------------------------------------------------------------------|----------------------------------------------------------------------------|---------| | | | Aging | Ultimate<br>Elongation | 380 % min | 380 % min | SAME | | | | After | Tensile<br>Strength | 15 MPa, min | 15 MPa, min | | | | | Aging | Ultimate<br>Elongation | 380 % min | 380 % min | | | | | | Comply with ASTM D5250 | Comply with ASTM D5250 | SAME | | | | Freedom from Holes | | | Be free from holes when tested in<br>accordance with ASTM D5151<br>AQL=1.5 | Be free from holes when tested<br>in accordance with ASTM<br>D5151 AQL=1.5 | SAME | | | Powder Content | | | 0.5 mg | Meet the requirements of ASTM<br>5250 | SIMILAR | ### Table 4 Safety Comparison | ITEM | Proposed Device | Predicate Device (K163168) | Remark | | |--------------------|-------------------------|--------------------------------------------------------------------------------|--------------------------|---------| | Material | Vinyl | Vinyl | SIMILAR | | | Biocompatibility | Irritation | Under the conditions of the study, not an irritant | Comply with ISO 10993-10 | SIMILAR | | | Sensitization | Under conditions of the study, not a sensitizer. | | | | | Cytotoxicity | Under conditions of the study, did not show potential toxicity to L-929 cells. | / | | | Label and Labeling | Meet FDA's Requirements | Meet FDA's Requirements | SAME | | Analysis 1: The proposed device has different color to the predicate device, but all proposed devices are conducted the biocompatibility test, the test results shown difference do not effect the safety of proposed device. #### 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 {7}------------------------------------------------ Cytotoxicity - > ASTM D6124-06 (Reaffirmation 2011), 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.