Nitrile Patient Examination Glove

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains 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 square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. December 14, 2022 PingAn Medical Products Co.,Ltd. % Boyle Wang Shanghai Truthful Information Technology Co., Ltd. RM. 608, No. 738, Shangcheng Rd., Pudong Shanghai, Shanghai 200120 China Re: K222527 Trade/Device Name: Nitrile Patient Examination Glove Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA Dated: November 14, 2022 Received: November 14, 2022 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. 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 {1}------------------------------------------------ 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 medical devices and radiation-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, # Bifeng Qian -S Bifeng Qian, M.D., Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ #### Indications for Use 510(k) Number (if known) K222527 Device Name Nitrile Patient Examination Glove Indications for Use (Describe) The Nitrile Patient Examination Glove is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hands or finger 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 (K222527) This summary of 510(k) is being submitted in accordance with 21 CFR 807.92. #### 1.0 Submitter's Information PingAn Medical Products Co.,Ltd. Name: Address: Zheji road, High-tech Industrial Zone of Hukou County, Jiujiang City, Jiangxi Province, China Phone Number: +86-15247135174 Contact: Zhou Ziyu Date of Preparation: 2022.07.20 #### 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: Nitrile Patient Examination Glove Common name: Patient Examination Gloves Classification name: Non-powdered patient examination glove Model(s): S, M, L, XL #### 3.0 Classification Production code: LZA Regulation number: 21CFR880.6250 Classification: Class I Panel: General Hospital #### 4.0 Predicate Device Information Manufacturer: Yingxiang Glove Products Co., Ltd. Device: Nitrile Patient Examination Gloves 510(k) number: K211914 {4}------------------------------------------------ #### 5.0 Indication for Use The Nitrile Patient Examination Glove is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner. #### 6.0 Device Description The subject device is powder free nitrile examination gloves. The subject device is blue. The subject device is non-sterile. #### 7.0 Technological Characteristic Comparison Table | Table1-General Comparison | | | | |--------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------| | Item | Subject Device<br>(K222527) | Predicated Device<br>(K211914) | Remark | | Product Code | LZA | LZA | Same | | Regulation No. | 21CFR880.6250 | 21CFR880.6250 | Same | | Class | I | I | Same | | Intended Use /<br>Indication for Use | The Nitrile Patient<br>Examination Glove is a<br>non-sterile disposable<br>device intended for<br>medical purposes that is<br>worn on the examiner's<br>hands or finger to prevent<br>contamination between<br>patient and examiner. | The Nitrile Patient<br>Examination Gloves is a<br>disposable device<br>intended for medical purposes<br>that is worn on the<br>examiner's hands to prevent<br>contamination between<br>patient and examiner. | Same | | Powdered or<br>Powered free | Powdered free | Powdered free | Same | | Design Feature | Ambidextrous | Ambidextrous | Same | | Labeling<br>Information | Single-use indication,<br>powder free, device color,<br>device name, glove size<br>and quantity, Nitrile Glove<br>Powder Free Blue,<br>Non-Sterile | Single-use indication,<br>powder free, device<br>color, device name,<br>glove size and quantity,<br>Disposable Powder Free<br>Nitrile Examination<br>Glove, Non-Sterile | Same | #### Table1-General Comparison #### Table2 Device Dimensions Comparison {5}------------------------------------------------ | | Size | | | | | | | |----------------------------------|--------------------|----------------|------|-----|-----|-----|-----------| | Predicate<br>Device<br>(K211914) | Designation | | S | M | L | XL | Tolerance | | | 9-inch | Length, mm | 220 | 230 | 230 | 230 | min | | | | Width, mm | 80 | 95 | 110 | 120 | ±10 | | | 12-inch | Length, mm | 220 | 230 | 230 | 230 | min | | | | Width, mm | 80 | 95 | 110 | 120 | ±10 | | | Thickness, mm: | | | | | | | | | 9-inch/<br>12-inch | Finger<br>Palm | 0.05 | | | | min | | | | | 0.05 | | | | min | | Subject<br>Device | 12 inch | Designation | S | M | L | XL | Tolerance | | | | Length, mm | 220 | 230 | 230 | 230 | min | | | | Width, mm | 80 | 95 | 110 | 120 | ±10 | | | | Thickness, mm: | | | | | | | | | Finger | 0.05 | | | | min | | | | Palm | 0.05 | | | | min | | | | SIMILAR | | | | | | Analysis: The physical dimensions of subject device are same with the 12 inch ones of the predicate device, and they all meet the requirements of ASTM D6319-19. | Item | Subject device (Pending) | Predicated device (K211914) | Remark | | |---------------------|---------------------------------------------------------------------|---------------------------------------------------------------------|------------|------| | Colorant | Blue | Blue | Same | | | Physical Properties | Before Aging<br>Tensile Strength | 14MPa, min | 14MPa, min | Same | | | Before Aging<br>Ultimate Elongation | 500% min | 500% min | Same | | | After Aging<br>Tensile Strength | 14MPa, min | 14MPa, min | Same | | | After Aging<br>Ultimate Elongation | 400%min | 400%min | Same | | | Comply with ASTM D6319 | Comply with ASTM D6319 | Same | | | Freedom from Holes | Be free from holes when tested in accordance with ASTMD5151 AQL=2.5 | Be free from holes when tested in accordance with ASTMD5151 AQL=2.5 | Same | | #### Table3 Performance Comparison {6}------------------------------------------------ | Powder Content | 0.24 mg/glove | Meet the requirements of Similar<br>ASTM D6124 | |----------------|---------------|------------------------------------------------| |----------------|---------------|------------------------------------------------| #### Table4 Safety Comparison | Item | | Subject device (Pending) | Predicated device (K211914) | Remark | |--------------------|-----------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------|-----------------------------|---------| | Material | | Nitrile | Nitrile | Same | | Biocompatibility | Irritation (ISO 10993-10:2010 Biological Evaluation of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization) | Under the conditions of the study, not an irritant | | | | | Sensitization (ISO 10993-10:2010 Biological Evaluation of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization) | Under conditions of the study, not a sensitizer. | Comply with ISO10993-10 | Same | | | Cytotoxicity (ISO 10993-5:2009 Biological Evaluation of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity) | Under conditions of the study, device extract is not cytotoxic | Comply with ISO10993-5 | Similar | | Label and Labeling | | Meet FDA's Requirement | Meet FDA's Requirement | SAME | #### 8.0 Summary of Non-Clinical Performance Testing The following performance data has been provided to demonstrate that the subject device meets the acceptance criteria in the standard. {7}------------------------------------------------ ### Table 5 Summary of Non-Clinical Performance Testing | No. | Name of the Test<br>Methodology / Standard | Purpose | Acceptance Criteria | Results | |-----|--------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 1 | ISO 10993-10:2010<br>Biological Evaluation Of<br>Medical Devices - Part<br>10: Tests For Irritation<br>And Skin Sensitization. | This part of ISO 10993 assesses possible contact hazards from chemicals released from | Skin Sensitization<br>Test:<br>provided grades less than 1, otherwise sensitization. | All grades are 0.<br>All animals were survived and no abnormal signs were observed during the study. | | 2 | | medical devices, which may produce skin and mucosal irritation, eye irritation or skin sensitization. | Skin Irritation Test:<br>If the primary irritation index is 0-0,4, the response category is Negligible.<br>0,5-1,9 means slight 2-4,9 means moderate 5-8 means severe | The primary irritation index is 0.<br>The response of the proposed device was categorized as negligible under the test condition | | 3 | ISO 10993-5:2009<br>Biological Evaluation Of<br>Medical Devices - Part<br>5: Tests For In Vitro<br>Cytotoxicity | This part of ISO 10993 describes test methods to assess the in vitro cytotoxicity of medical devices. | The viab.% of the 100% extract of the test article is the final result, and if viability is reduced to <70% of the blank, it has cytotoxic potential. | Viab.% of 100% test article extract is 74.2%<br>It means the proposed device have potential toxicity to L-929 in the MTT method | | 4 | ASTM D6124-06<br>(Reapproved 2017),<br>Standard Test Method<br>for Residual Powder on<br>Medical Gloves | This standard is designed to determine the amount of residual powder (or filter-retained mass) found on medical gloves | powder residue limit of 2.0 mg | 0.24 mg /glove | | 5 | ASTM<br>D5151-06(Reapproved2<br>015), Standard Test<br>Method for Detection of<br>Holes in Medical Gloves. | This test method covers the detection of holes in medical gloves. | Samples number: 125 gloves<br>AQL: 2.5 (ISO 2859)<br>Criterion ≤7 gloves for water leakage | 0 glove water leakage found | | 6 | ASTM<br>D6319-10(Reapproved<br>2015),Standard<br>Specification For Nitrile<br>Examination Gloves For<br>Medical Application. | This specification<br>covers certain<br>requirements for<br>nitrile rubber<br>gloves used in<br>conducting<br>medical<br>examinations and<br>diagnostic and<br>therapeutic<br>procedures. | Sterility: no need<br>Freedom from holes:<br>pl. Refer to No. 5 in<br>table 5<br>Dimensions:<br>S: width 80±10mm<br>Length $\ge$ 220 mm<br>M: width 95±10mm<br>Length $\ge$ 230 mm<br>L: width 110±10mm<br>Length $\ge$ 230 mm<br>XL: width 120±10mm<br>Length $\ge$ 230 mm<br>Thickness:<br>Finger $\ge$ 0.05 mm<br>Palm $\ge$ 0.05 mm | Lot no.:JX220117<br>Dimensions:<br>S: width: 84-86 mm<br>Length 295-304 mm<br>Thickness:<br>Finger 0.136-0.155 mm<br>Palm 0.109-0.125 mm<br>M: width 94-97 mm<br>Length 296-302mm<br>Thickness:<br>Finger 0.136-0.155 mm<br>Palm 0.109-0.125 mm<br>L: width 104-107 mm<br>Length 297-302 mm<br>Thickness:<br>Finger 0.150-0.171 mm<br>Palm 0.112-0.125 mm<br>XL: width 113-117 mm<br>Length 296-303 mm<br>Thickness:<br>Finger 0.154-0.168 mm<br>Palm 0.113-0.129 mm<br>Physical properties:<br>Before aging<br>Tensile strength 17.9-40.5MPa<br>Ultimate Elongation 508.945% -<br>574.078%<br>After Accelerated Aging<br>Tensile strength 14.2-27.1 MPa<br>Ultimate Elongation 402.900% -<br>538.033%<br>Powder-free Residue:<br>pl. Refer to No. 4 in table 5<br>Physical properties:<br>Before aging<br>Tensile strength $\ge$ 14MPa<br>Ultimate Elongation $\ge$ 500%<br>After Accelerated<br>Aging<br>Tensile strength $\ge$ 14MPa<br>Ultimate Elongation $\ge$ 400%<br>Powder-free Residue:<br>pl. Refer to No. 4 in<br>table 5 | {8}------------------------------------------------ #### 9.0 Discussion of Clinical and Performance Testing Clinical testing is not needed for this device. {9}------------------------------------------------ #### 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.