Disposable Vinyl Glove

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and 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 10, 2020 Best Care Trading Co., LTD % Boyle Wang Official Correspondent Shanghai Truthful Information Technology Co., Ltd. RM. 608, No. 738, Shangcheng Rd., Pudong Shanghai, Shanghai 200120 China Re: K202008 Trade/Device Name: Disposable Vinyl Glove Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LYZ Dated: June 15, 2020 Received: July 21, 2020 Dear Boyle 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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-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 Elizabeth Claverie, M.S. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K202008 Device Name Disposable Vinyl Glove Indications for Use (Describe) The Disposable Vinyl Glove is 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 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}------------------------------------------------ # 510(k) Summary K202008 This summary of 510(k) is being submitted in accordance with 21 CFR 807.92. #### 1.0 Submitter's Information Best Care Trading Co.,Ltd. Name: Address: Yuying Village, Fangzhen, Zhangdian District, 255000 Zibo, Shandong,China. Phone Number: +86-13508943885 Contact: Mr. Chongfeng Zhao Date of Preparation: 9/4/2020 #### Designated Submission Correspondent Mr. Boyle Wang Shanghai Truthful Information Technology Co., Ltd. Room 608, No. 738 Shangcheng Rd., Pudong Shanghai, 200120 China Tel: +86-21-50313932 Email: Info@truthful.com.cn #### 2.0 Device information Trade name: Disposable Vinyl Gloves Common name: Vinyl Patient Examination Glove Classification name: Non-powdered Patient Examination Glove Model(s): XS, S, M, L, XL #### 3.0 Classification Production code: LYZ Regulation number: 21CFR880.6250 Classification: Class I Panel: General Hospital #### 4.0 Predicate device information Hebei Hongtai Plastic Products Company Limited Manufacturer: {4}------------------------------------------------ Vinyl Patient Examination Gloves (White, Blue, Yellow) Device: 510(k) number: K163168 ### 5.0 Indication for Use The Disposable Vinyl Glove is intended for medical purposes that is worn on the examiners hands to prevent contamination between patient and examiner. ### 6.0 Device description The subject device is powder free vinyl patient examination gloves. The subject device is clear, non-colored. The design of subject device is addressing the standards as ASTM D6124, ASTM D5151, and ASTM D5250. The subject device is non-sterile. #### 7.0 Summary comparing technological characteristics with predicate device | Item | Subject device | Predicated device | Comparison | |--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------| | 510(k) number | K202008 | K163168 | / | | Product Code | LYZ | LYZ | Same | | Regulation No. | 21CFR880.6250 | 21CFR880.6250 | Same | | Class | | | Same | | Intended Use | The Disposable Vinyl<br>Glove is a disposable<br>device intended for<br>medical purposes that is<br>worn on the examiner's<br>hands to prevent<br>contamination between<br>patient and examiner. | The Vinyl Examination<br>Glove (White, Blue, or<br>Yellow) is a disposable<br>device intended for<br>medical purposes that<br>is worn on the<br>examiner's hands to<br>prevent contamination<br>between patient and<br>examiner. | Same | | Powdered or Powered free | Powdered free | Powdered free | Same | | Design Feature | ambidextrous | ambidextrous | Same | | Labeling Information | Single use, powder free,<br>device color, device<br>name, glove size and<br>quantity, Vinyl<br>Examination Gloves,<br>Non-Sterile | Single use, powder<br>free, device color,<br>device name, glove<br>size and quantity, Vinyl<br>Examination Gloves,<br>Non-Sterile | Similar | #### Table1-General Comparison #### Table2 Device Dimensions Comparison {5}------------------------------------------------ | Predicate<br>Device(K163168) | Designation | Size | | | | Tolerance | | |------------------------------|----------------|------|-----|-----|-----|-----------|-----| | | Length, mm | 230 | 230 | 235 | 245 | 245 | min | | | Width, mm | 80 | 85 | 95 | 105 | 115 | ±5 | | | Thickness, mm: | | | | | | | | | Finger | 0.05 | | | | min | | | | Palm | 0.08 | | | | min | | | Subject Device | Designation | Size | | | | Tolerance | | | | Length, mm | 240 | 240 | 240 | 240 | 240 | min | | | Width, mm | 80 | 85 | 95 | 105 | 115 | ±5 | | | Thickness, mm: | | | | | | | | | Finger | 0.05 | | | | min | | | | Palm | 0.08 | | | | min | | | Remark | SAME | | | | | | | ### Table3 Performance Comparison | Item | Subject device | Predicated device | Comparison | | | |------------------------|-------------------------------------------------------------------------------------|----------------------------------------------------------------------------|------------|------------|-----------| | Colorant | Clear, Non-Colored | White, Blue, Yellow | Analysis1 | | | | Physical<br>Properties | Before<br>Aging | Tensile<br>Strength | 14MPa, min | 15MPa, min | Analysis2 | | | | Ultimate<br>Elongation | 500%min | 380%min | Analysis2 | | | After<br>Aging | Tensile<br>Strength | 14MPa, min | 15MPa, min | Analysis2 | | | | Ultimate<br>Elongation | 400%min | 380%min | Analysis2 | | | Comply with ASTM D5250 | Comply with ASTM D5250 | SAME | | | | Freedom from Holes | Be free from holes when<br>tested in<br>accordance with<br>ASTM<br>D5151<br>AQL=2.5 | Be free from holes when<br>tested in accordance with<br>ASTM D5151 AQL=2.5 | SAME | | | | Powder Content | < 0.08 mg per<br>glove | Meet the requirements of<br>ASTM D6124 | SIMILAR | | | Analysis1: The subject device (colorless) has different color to the predicate device (White, Blue, Yellow), but all proposed devices are conducted the biocompatibility test, the test results shown that the color difference do not affect the safety of proposed device. Analysis2: The tensile strength and ultimate elongation are different with that of the predicate,but they all meet the requirements of ASTM D5250,so the differences do not raise any new safety or performance questions. {6}------------------------------------------------ | Item | Subject device | Predicated device | Comparison | | |--------------------|------------------------|--------------------------------------------------------------------------------|-------------------------|---------| | Material | Vinyl | Vinyl | SAME | | | Biocompatibility | Irritation | Under the conditions of the study, not an irritant | Comply with ISO10993-10 | SAME | | | Sensitization | Under conditions of the study, not a sensitizer. | | | | | Cytotoxicity | Under conditions of the study, did not show potential toxicity to L-929 cells. | / | SIMILAR | | Label and Labeling | Meet FDA's Requirement | Meet FDA's Requirement | SAME | | ### Table4 Safety Comparison # 8.0 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 Cytotoxicity ASTM D6124-06 (Reapproved 2017), Standard Test Method for Residual Powder on Medical Gloves ASTMD5151-06(Reapproved2015), Standard Test Method for Detection of Holes in Medical Gloves. ASTM D5250-19, Standard Specification for Poly (vinyl chloride) Gloves for Medical Application. #### 9.0 Clinical Test Conclusion Clinical testing is not needed for this device. #### 10.0 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 predicated device.