Nitrile Examination Gloves, Dual Color Black-Blue

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. October 20, 2023 Shanxi Hongjin Plastic Technology Co., Ltd. Zhigang Wu General Manager Coal Bed Gas Industrial Zone, Qu'e Town, Daning County Linfen, Shanxi 042300 China Re: K232550 Trade/Device Name: Nitrile Examination Gloves, Dual Color Black-Blue Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA Dated: August 20, 2023 Received: August 23, 2023 Dear Zhigang Wu: 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 (the 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 available 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. Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" {1}------------------------------------------------ (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). 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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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). {2}------------------------------------------------ Sincerely, # Bifeng Qian -S Bifeng Qian, M.D., Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic and Reconstructive Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ ## Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below. Submission Number (if known) K232550 Device Name Nitrile Examination Gloves, Dual Color Black-Blue Indications for Use (Describe) The glove is a disposable device intended for medical purposes that is worn on the examiner's hand 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." {4}------------------------------------------------ Coal Bed Gas Industrial Zone, Qu'e Town, Daning County, Linfen City, Shanxi Province ## 510(K) SUMMARY The assigned 510(K) numbers: K232550 Date Prepared: October 13, 2023 ## 1. Owner's Identification: Mr. Wu Zhigang Shanxi Hongjin Plastic Technology Co., Ltd. Coal Bed Gas Industrial Zone, Qu'e Town, Daning County, Linfen City, Shanxi Province Email: fdareg@hongray.com.cn Contact: Mr. Wu Zhigang/General Manager Address: 3973 Schaefer Avenue, Chino, CA 91710, USA Tel: 909-590-1611 Email: janicema@hongrayusa.com ## 2. Name of the Device: Trade / Product Name: Nitrile Examination Gloves, Dual Color Black-Blue Common Name: Exam Gloves Classification Name: Non-powdered Patient Examination Glove Classification Regulation: 21 CFR 880.6250 Product Code: LZA Classification Panel: General Hospital Device Class: Class I ## 3. Predicate Device Information: Careplus (M) SDN BHD. Powder Free Nitrile Examination Glove Black and Dual Color White-Blue (K201857) ## 4. Device Description: Nitrile Examination Gloves, Dual Color Black-Blue are Class I Patient Examination Gloves. The glove is made dual color by double dipping. They are ambidextrous and come in different sizes - Extra Small, Small, Medium, Large, Extra Large and XXL. Gloves meet the specification of ASTM D6319-19. The gloves are single use, disposable, and provided non-sterile. ## 5. Indications for Use: The Glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. ## 6. Comparison of Subject Device and Predicate Device: | | Subject Device<br>K232550 | Predicate Device<br>K201857 | Comparison<br>Result | |-------------------|---------------------------------------------------|-----------------------------------------------------------------------|----------------------| | Trade Name | Nitrile Examination Gloves, Dual Color Black-Blue | Powder Free Nitrile Examination Glove Black and Dual Color White-Blue | Similar | | Product Code | LZA | LZA | Same | | Regulation Number | 21 CFR 880.6250 | 21 CFR 880.6250 | Same | {5}------------------------------------------------ Coal Bed Gas Industrial Zone, Qu'e Town, Daning County, Linfen City, Shanxi Province ### 510(K) SUMMARY | Class | I | I | Same | |-----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------| | Indications for Use | Nitrile Examination Gloves, Dual<br>Color Black-Blue is a disposable<br>device intended for medical<br>purposes that is worn on the<br>examiner's hand to prevent<br>contamination between patient and<br>examiner. | Powder Free Nitrile Examination Glove<br>Black and Dual Color White-Blue is a<br>disposable device intended for medical<br>purpose that is worn on the examiner's<br>hand or finger to prevent contamination<br>between examiner and patient. | Same | | Material | Nitrile | Nitrile | Same | | Powder or Powder Free | Powder Free | Powder Free | Same | | Color | Black-Blue | White-Blue | Similar | | Single use | Single use | Single use | Same | ## Technological Characteristic Comparison Table: | Technological<br>Characteristics | Subject Device<br>K232550 | Predicate Device<br>K201857 | Comparison | |-------------------------------------------------|-------------------------------------------------------------|--------------------------------------------------------------|------------| | Length | Minimum 220mm for size XS-S<br>Minimum 230mm for size M-XXL | Minimum 220mm for size XS-S<br>Minimum 230mm for size M-XXXL | Different* | | Palm Width (size) (mm) | | | | | XS | 70±10 | 70±10 | Same | | S | 80±10 | 80±10 | Same | | M | 95±10 | 95±10 | Same | | L | 110±10 | 110±10 | Same | | XL | 120±10 | 120±10 | Same | | XXL | 130±10 | 130±10 | Same | | XXXL | No | 126-132 | Different* | | Thickness(mm) | | | | | Finger | Minimum 0.05 | Minimum 0.05 | Same | | Palm | Minimum 0.05 | Minimum 0.05 | Same | | Tensile Strength, Before<br>Aging | 14MPa, min | 14MPa, min | Same | | Ultimate<br>Elongation, Before<br>Aging | 500%, min | 500%, min | Same | | Tensile Strength, After<br>Accelerated Aging | 14MPa, min | 14MPa, min | Same | | Ultimate Elongation,<br>After Accelerated Aging | 400%, min | 400%, min | Same | | Watertight (1000ml) | 21 CFR 800.20<br>ASTM D5151<br>G-I, AQL 2.5 | 21 CFR 800.20<br>ASTM D5151<br>G-I, AQL 2.5 | Same | {6}------------------------------------------------ Coal Bed Gas Industrial Zone, Qu'e Town, Daning County, Linfen City, Shanxi Province ## 510(K) SUMMARY | Powder-Content | ≤ 2 mg per glove | ≤ 2 mg per glove | Same | |------------------------------------------------------|-------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------|---------| | 10993-23:2021 Skin<br>Irritation Study | Under the conditions of the<br>study, not an irritant | Under the conditions of the study,<br>the subject device is non-irritating | Same | | 10993-10:2021<br>Maximization Sensitization<br>Study | Under the conditions of the study,<br>not a sensitizer | Under the conditions of the study,<br>the subject device is non<br>sensitization | Same | | 10993-5:2009 Cytotoxicity<br>Test | Under the conditions of this study,<br>the test article extract showed<br>potential toxicity to L929 cells. | Cytotoxic (grade >2) at undiluted,<br>1:2, 1:4, 1:8 and Noncyctotoxic,<br>grade <2 at dilutions;1:16,1:32 and<br>1:64. | Similar | | ISO 10993-11:2017 Acute<br>Systemic toxicity study | Under the conditions of this study,<br>there was no evidence of systemic<br>toxicity. | Under the conditions of this study,<br>the test material did not reveal<br>systemic toxicity | Same | *The difference is for dimension and does not raise different questions of safectiveness and does not affect the substantial equivalence in effectiveness and safety. ## 7. Summary of Non-Clinical Performance Data Non-clinical tests were conducted to verify that the proposed device met all design specifications. The test results demonstrated that the proposed device met the performance criteria with the following standards: | Methodology | Test Performed | Acceptance Criteria | Results | |---------------------------------------|-----------------------------------|------------------------------------------------------------------------------------------|------------------------------------------| | ASTM D6319-19 | Physical Dimensions Length | Minimum 220mm for size XS-S<br>Minimum 230mm for size M-XXL | Pass | | ASTM D6319-19 | Physical Dimensions Palm Width | XS: 70±10mm<br>S: 80±10mm<br>M: 95±10mm<br>L:110±10mm<br>XL: 120±10mm<br>XXL: 130±10mm | Pass | | ASTM D6319-19 | Physical Dimensions Thickness | Finger: 0.05mm (min)<br>Palm: 0.05mm (min) | Pass | | ASTM D6319-19<br>ASTM D412-16(2021) | Physical Properties | Tensile Strength (Min14 MPa) and Elongation (Before Aging 500% and after aging 400%) Min | Pass | | ASTM D6319-19<br>ASTM D5151-19 | Water leak test | G-I, AQL 2.5 (ISO 2859-1) | Pass | | ASTM D6319-19<br>ASTM D6124-06 (2017) | Powder Residue | Max 2mg/glove | Pass | | ISO 10993-10 &23:2021 | Irritation and Skin Sensitization | Skin sensitization and Skin irritation | Is non-sensitization and Non-irritation | | ISO 10993-5:2009 | Cytotoxicity | Cytotoxicity reactivity | showed potential toxicity to L929 cells. | | ISO 10993-11:2017 | Acute systemic toxicity study | Subject showed no adverse biological reaction | no evidence of systemic toxicity. | - ASTM D6319-19, Standard Specification for Nitrile Examination Gloves for Medical Application. ● {7}------------------------------------------------ Coal Bed Gas Industrial Zone, Qu'e Town, Daning County, Linfen City, Shanxi Province ## 510(K) SUMMARY - ASTM D5151-19, Standard Test Method for Detection of Holes in Medical Gloves. ● - ASTM D6124-06 (Reapproved 2017), Standard Test Method for Residual Powder on Medical Gloves . - ASTM D412-16 (2021) Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers-Tension - ISO 10993-10:2021 Biological Evaluation of Medical Devices Part 10: Tests For Skin Sensitization. ● - ISO 10993-5:2009 Biological Evaluation of Medical Devices Part 5: Tests For In Vitro Cytotoxicity ● - ISO 10993-23:2021 Biological Evaluation of Medical Devices Part 10: Tests For Skin Irritation. . - ISO 10993-11:2017 Biological evaluation of medical devices Part 11: Tests for systemic toxicity ● ## 8. Clinical Performance Data N/A ## 9. 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.