Powder Free Nitrile Examination Gloves, Orange

{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: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters. March 26, 2022 Shanxi Hongjin Plastic Technology Co., Ltd. % Kathy Liu Project Manager Hongray USA Medical Products Inc. 3973 Schaefer Avenue Chino, California 91710 Re: K220229 Trade/Device Name: Powder Free Nitrile Examination Gloves, Orange Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA Dated: January 20, 2022 Received: January 27, 2022 Dear Kathy Liu: 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, Clarence W. Murray, III, PhD 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) K220229 Device Name Powder Free Nitrile Examination Gloves, Orange Indications for Use (Describe) Powder Free Nitrile Examination Gloves, Orange is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. 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}------------------------------------------------ # Shanxi Hongjin Plastic Technology Co., Ltd. Coal Bed Gas Industrial Zone, Qu'e Town, Daning County, Linfen City, Shanxi Province ## 510(K) SUMMARY The assigned 510(K) number: K220229 Date Prepared: January 20, 2022 ## 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 Tel: 86-311-66766067 Contact: Ms. Kathy Liu, Project Manager Address: 3973 Schaefer Avenue, Chino, CA 91710, USA Tel: 909-590-1611 Email: kathyliu@hongrayusa.com or fdareg@126.com #### 2. Name of the Device: Trade / Product Name: Powder Free Nitrile Examination Gloves, Orange Common Name: Patient Examination Gloves Classification Name: Patient Examination Glove Classification Regulation: 21 CFR 880.6250 Product Code: LZA Classification Panel: General Hospital Device Class: Class I ### 3. Predicate Device Information: Wrp Asia Pacific Sdn Bhd Powder Free Nitrile Patient Examination Gloves, Non-Sterile (Orange) (K192635) #### 4. Device Description: Powder Free Nitrile Examination Gloves, Orange are Patient Examination Gloves, Disposable, single use only and non-sterile. The gloves are made of nitrile latex and are powder free. They are ambidextrous. The physical and performance characteristics of the devices meet all requirements of ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application. #### 5. Indications for Use: Powder Free Nitrile Examination Gloves, Orange is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. #### Comparison of Subject Device and Predicate Device: 6. The subject device will be known as Powder Free Nitrile Examination Gloves, Orange. The following tables are summaries of the technological characteristics, biocompatibility of the subject and predicate devices. | Characteristics | Standards | Subject Device<br>K220229 | Predicate Device<br>K192635 | Comparison<br>Analysis | |-----------------|---------------|------------------------------------------------------|-----------------------------------------------------------------------------|------------------------| | Material | ASTM D6319-19 | Nitrile | Nitrile | Same | | Color | - | Orange | Orange | Same | | Texture | - | Hand textured | Hand textured | Same | | Trade Name | - | Powder Free Nitrile<br>Examination Gloves,<br>Orange | Powder Free Nitrile Patient<br>Examination Gloves, Non-<br>Sterile (Orange) | Similar | | Product Code | - | LZA | LZA | Same | General Comparison Table: {4}------------------------------------------------ # Shanxi Hongjin Plastic Technology Co., Ltd. Coal Bed Gas Industrial Zone, Qu'e Town, Daning County, Linfen City, Shanxi Province ## 510(K) SUMMARY | Regulation Number | - | 21 CFR 880.6250 | 21 CFR 880.6250 | Same | |-----------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------| | Class | | I | I | Same | | Physical Properties<br>Before Aging<br>Tensile Strength:<br>Ultimate Elongation:<br>After Aging<br>Tensile Strength:<br>Ultimate Elongation : | ASTM D6319-19 | 14MPa min<br>500% min<br>14MPa min<br>400% min | 14MPa min<br>500% min<br>14MPa min<br>400% min | Same | | Thickness<br>- Finger<br>- Palm | ASTM D6319-19 | 0.16-0.22mm<br>0.15-0.18mm | 0.21-0.23mm<br>0.19-0.22mm | Different | | Powder Free | ASTM D6124–<br>06(2017) | ≤ 2 mg/glove | ≤ 2 mg/glove | Same | | Biocompatibility<br>Primary Skin Irritation<br>Test | ISO 10993-10:2010 | Under conditions of the study,<br>not an irritant | Not a primary skin irritant | Same | | Biocompatibility<br>Dermal Sensitization<br>Study | ISO 10993-10:2010 | Under conditions of the study,<br>not a sensitizer | Not a contact sensitizer | Same | | Biocompatibility<br>Cytotoxicity | ISO 10993-5:2009 | Under the conditions of this<br>study, the test article extract<br>showed potential toxicity to<br>L929 cells.<br>Cytotoxicity concern was<br>addressed by acute systematic<br>toxicity testing. | Exhibit severe cytotoxicity<br>reactivity at 100%, 66%, and<br>44% extract concentration.<br>Moderate cytotoxicity<br>reactivity at 30%, mild<br>cytotoxicity reactivity at<br>20% and slight cytotoxicity<br>reactivity at 15% extract<br>concentrations.<br>Cytotoxicity concern was<br>addressed by acute systematic<br>toxicity testing. | Same | | Biocompatibility Acute<br>Systemic Toxicity | ISO 10993-11:2017 | It is concluded that the extracts<br>(polar and non-polar) of the<br>product did not show any<br>systemic toxicity | It is concluded that the extracts<br>(polar and non -polar) of the<br>product did not show any<br>systemic toxicity | Same | | Watertight (1000ml) | ASTM D5151-19 | Inspection Level 1, AQL 2.5 | Inspection Level 1, AQL 1.5 | Similar | | Indications for Use | - | A patient examination glove is<br>a disposable device intended<br>for medical purposes that is<br>worn on the examiner's hand or<br>finger to prevent contamination<br>between patient and examiner. | A patient examination glove is<br>a disposable device intended<br>for medical purposes that is<br>worn on the examiner's hand or<br>finger to prevent contamination<br>between patient and examiner. | Same | | Size | Medical Glove<br>Guidance Manual<br>– Labeling | XS, S, M, L, XL, XXL | XS, S, M, L, XL | Similar | | Single use | Medical Glove<br>Guidance Manual<br>– Labeling | Single use | Single use | Same | There are no significant differences between the two products and are identical in terms of intended use, materials, design, manufacturing methods except for size and thickness. The subject device is one more extra size XXL and thinner than predicate device. {5}------------------------------------------------ # Shanxi Hongjin Plastic Technology Co., Ltd. Coal Bed Gas Industrial Zone, Qu'e Town, Daning County, Linfen City, Shanxi Province ## 510(K) SUMMARY ### 7. Summary of Non-Clinical Testing Non-clinical tests were conducted to verify that the subject device met all design specifications. The test results demonstrated that the subject device complies with the following standards: The performance test data of the non-clinical tests for this powder free nitrile examination glove is summarized as per below. | Test method | Purpose | Acceptance Criteria | Results | Status | |---------------------------------------|-------------------------------------------------|----------------------|---------------------------------------|--------| | ASTM D6319-19 | Length | Minimum 230mm | All size ≥230 | Pass | | ASTM D6319-19 | Palm Width | XS: 70±10mm | 76-78mm | Pass | | | | S: 80±10mm | 86-88 mm | Pass | | | | M:95±10mm | 96 -98mm | Pass | | | | L:110±10mm | 106-108 mm | Pass | | | | XL: 120±10mm | 116-118 mm | Pass | | | | XXL: 130±10mm | 126-128 mm | Pass | | ASTM D6319-19 | Thickness | Finger: 0.05mm (min) | 0.15-0.18mm | Pass | | | | Palm: 0.05mm (min) | 0.16-0.22mm | Pass | | ASTM D6319-19<br>ASTN D412-16 | Tensile Strength, Before<br>Aging | 14MPa, min | 15.8-19.9Mpa | Pass | | ASTM D6319-19<br>ASTN D412-16 | Tensile Strength, After<br>Accelerated Aging | 14MPa, min | 15.2-18.8Mpa | Pass | | ASTM D6319-19<br>ASTN D412-16 | Ultimate Elongation, Before<br>Aging | 500%, min | 500-550% | Pass | | ASTM D6319-19<br>ASTN D412-16 | Ultimate Elongation, After<br>Accelerated Aging | 400%, min | 430-500% | Pass | | ASTM D 5151-19<br>ASTM D6319-19 | Freedom from holes | G-I, AQL 2.5 | Meet and above AQL2.5<br>requirements | Pass | | ASTM D 6124-06(2017)<br>ASTM D6319-19 | Powder-Content | ≤ 2 mg per glove | 0.55-0.78 mg | Pass | #### 8. Summary of Clinical Testing No Clinical study is included in this submission. #### Conclusion: 9. The conclusions drawn from the non-clinical tests demonstrate that the subject device is as safe, as effective, and performs as well as or better than the legally marketed predicated device, K192635.