Disposable Medical Nitrile Examination Gloves (Model:XYS-001)

{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. December 9, 2021 Anhui Xinyisheng Medical Technology Co.,Ltd % Dave Yungvirt, CEO Official Correspondent THIRD PARTY REVIEW GROUP, LLC 25 Independence Blvd Warren, NJ 07059 Re: K213371 Trade/Device Name: Disposable Medical Nitrile Examination Gloves (Model:XYS-001) Regulation Number: 21 CFR 880.6250 Regulation Name: Non-powdered patient examination glove Regulatory Class: Class I, reserved Product Code: LZA Dated: November 29, 2021 Received: December 2, 2021 Dear Dave Yungvirt : 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, For 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 Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ### Indications for Use 510(k) Number (if known) K213371 Device Name Disposable Medical Nitrile Examination Gloves(Model:XYS-001) Indications for Use (Describe) The Disposable Medical Nitrile Examination Gloves is disposable device intended for medical purpose 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." {3}------------------------------------------------ ### 510(K) Summary Prepared in accordance with the requirements of 21 CFR Part 807.92 #### Prepared Date: Oct.11, 2021 ### 1. Submitter's Information The submitter of this pre-market notification is: | Name: | Anhui Xinyisheng Medical Technology Co.,Ltd | |-----------------|---------------------------------------------------------------------------------------------------------------| | Address: | No.999 North of the intersection of Tonghe Road and G343<br>Road Si County Suzhou City, Anhui Province, China | | Contact person: | Shyla Tang | | Title: | Manager | | E-mail: | shyla@xinlingroup.com | | Tel: | 86-18012883846 | ### 2. Device Identification | 510(K) number: | K213371 | |--------------------|-----------------------------------------------| | Trade/Device Name: | Disposable Medical Nitrile Examination Gloves | | Size of glove | Large | | Models: | XYS-001 | | Common name: | Polymer Patient Examination Glove | | Regulation Number: | 880.6250 | | Regulation Name: | Non-powdered patient examination glove | | Regulation Class: | Class I | | Panel: | General Hospital | | Product Code: | LZA | ### 3. Predicate Device | 510(K) number: | K192333 | |--------------------|---------------------------------------------------| | Device Name: | Blue Nitrile Examination Gloves Powder Free | | Manufacturer: | JR Engineering & Medical Technologies (M) SDN.BHD | | Common name | Polymer Patient Examination Glove | | Regulation Number: | 880.6250 | | Regulation Name: | Non-powdered patient examination glove | | Regulation Class: | Class I | | Panel: | General Hospital | | Product Code: | LZA | {4}------------------------------------------------ ### 4. Device Description Disposable Medical Nitrile Examination Gloves (Model: XYS-001, Size Large) is a patient examination qlove and it is made from nitrile compound. It is a single-use, powder-free and nonsterile product. The glove is worn on the examiner's hand to prevent contamination between patient and examiner, and this device meets all the requirement specifications in the ASTM D6319-19 Standard. #### 5. Indication for use The Disposable Medical Nitrile Examination Gloves is disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. #### 6. Summary of the technological characteristics of the device compared to the Predicate Device Compared to the predicate device, the subject device has the same intended use, similar product design, and similar performance as the predicate device, the summarized comparison information is listed in the following table: | SE Comparisons | Subject Device | Predicate Device<br>K192333 | Remarks | | |-------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|----------------| | Name | Disposable Medical Nitrile<br>Examination Gloves | Blue Nitrile Examination<br>Gloves Powder Free | / | | | Model | XYS-001 | / | / | | | Size | Large | Extra Small, Small,<br>Medium, Large, Extra<br>Large | See Note1 | | | Classification | Class I | Class I | Same | | | Intended use | The Disposable Medical<br>Nitrile Examination Gloves<br>is disposable device<br>intended for medical<br>purpose that is worn on<br>the examiner's hand to<br>prevent contamination<br>between patient and<br>examiner. | JR MEDIC Blue Nitrile<br>Examination Gloves<br>Powder Free is<br>disposable devices<br>intended for medical<br>purpose that are worn on<br>the examiner's hand to<br>prevent contamination<br>between patient and<br>examiner. | Same | | | Dimensions | ASTM D6319-<br>19 | Length Min:230mm<br>Width Min:110±10mm<br>(for Large size) | Length Min 230 mm<br>Width Min 95±10mm<br>(for medium size) | Note1 | | Physical<br>Properties | ASTM D6319-<br>19 | Before Aging<br>Tensile Strength Min 14<br>Mpa<br>Ultimate Elongation Min<br>500%<br>After Aging<br>Tensile Strength Min 14<br>Mpa<br>Ultimate Elongation Min<br>400% | Same | | | Thickness | ASTM D6319-<br>19 | Palm Min 0.05 mm<br>Finger Min 0.05 mm | Palm Min 0.05 mm<br>Finger Min 0.05 mm | Same | | Powder Free | ASTM D6319-<br>19 | ≤2 mg/glove | ≤2 mg/glove | Same | | Biocompatibility | ISO 10993-<br>10:2010 | / | Under the condition of<br>study not an<br>irritant | Note 2 | | | ISO 10993-<br>10:2010 | Under the conditions of<br>the study, the result shows<br>no<br>Intracutaneous Reactivity | / | | | | ISO 10993-<br>10:2010 | Under the conditions of<br>the study not a sensitizer | Under the conditions of<br>the study not a sensitizer | Same | | | ISO 10993-<br>5:2009 | Under the conditions of<br>the study,<br>cytotoxic.<br>Additional testing was<br>performed to determine if<br>this was a systemic<br>toxicity concern | Under the conditions of<br>the study,<br>cytotoxic.<br>Additional testing was<br>performed to determine if<br>this was a systemic<br>toxicity concern | Same<br>Note 3 | | | ISO 10993-<br>11:2017 | Under the condition of<br>study the device extracts<br>do not pose a systemic<br>toxicity concern | Under the condition of<br>study the device extracts<br>do not pose a systemic<br>toxicity concern | Same<br>Note 3 | | | ISO 10993-<br>11:2017 | / | Under the conditions of<br>the study, the device did<br>not demonstrate a<br>material mediated<br>pyrogenicity response. | Note 4 | | Power free | | Yes | Yes | Same | | Single Use | | Yes | Yes | Same | | Non-Sterile | | Yes | Yes | Same | | Color | | Blue | Blue | Same | | Intended use population | | Adult | Adult | Same | | Wear | | ambidextrous | ambidextrous | Same | | EXPIRE DATE | | Not claim | Included | See Note 5 | {5}------------------------------------------------ Note 1: In this submission, only one size "L" of glove was submitted for clearance and this size "L" of glove has been performed the testing according to the ASTM D6319-19, Note 2: According to the ISO 10993-10:2010, we conducted Intracutaneous reactivity test, Note 3: {6}------------------------------------------------ We evaluated the In vitro cytotoxicity in accordance with ISO 10993-5:2009s. Additionally we evaluated acute systemic toxicity in accordance with ISO 10993-11:2017. Note 4: We do not claim "non-pyrogenic" and we evaluated the biocompatibility per ISO 10993-1, the material mediated pyrogenicity testing is unnecessary. Note 5:According to FDA guidance, claiming shelf life is non-mandatory. #### 7. Performance Data Clinical test: Clinical testing is not required. #### Non-clinical data The following bench testing was conducted to demonstrate that the subject device met the performance specification or the acceptance criteria in the standard or the test methodology provided below in the table. The results demonstrate that the subject device met the performance specification and the acceptance criteria for the respected standard and test method below : Performance: 1. ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application. Freedom from Holes- Testing for freedom from holes were conducted in accordance with 2. Test Method ASTM D5151. 3. Physical Dimension test -Determine the dimension as directed in Table 2 of ASTM D6319-19. Physical Requirement Test-Before and accelerated aging, the physical requirement 4. specified in Table 3 of ASTM D6319-19, tests were conducted in accordance with test method ASTM D412 and accelerated aging test were conducted in accordance with Test Method ASTM D573. 5. Powder Free Gloves-Determine the powder residue in accordance with Test Method ASTM D6124. | Stand ard | Test item | Test<br>method | Criteria | Result | Conclusion | |-------------------|----------------------------------|-------------------------|------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|---------------------------------------------| | ASTM D6319<br>-19 | freedom<br>from holes | ASTM D5151 | Any glove that shows a<br>droplet, stream, or<br>other type of water<br>leakage shall be<br>considered to have<br>failed the test. | Did not show a<br>droplet, stream,<br>or other type of<br>water leakage | 200<br>samples tested<br>0 failures<br>Pass | | | Physical<br>Dimension<br>test | ASTM D412<br>ASTM D3767 | L size<br>Width:95±10mm<br>Length:230min<br>Thickness:<br>Finger 0.05min<br>Palm 0.05min | Width:<br>110mm<br>Length:<br>237mm<br>Thickness:<br>Finger 0.142mm<br>Palm 0.082mm | 13 samples tested/size<br>0 failure<br>Pass | | | Physical<br>Requiremen<br>t Test | ASTM D412<br>ASTM D573 | Tensile Strength:<br>Before Aging 14 Mpa,<br>min. | Tensile Strength:<br>Before Aging<br>19.1 Mpa, | 13 samples<br>tested/L size | {7}------------------------------------------------ | | | | After Aging 14 Mpa,<br>min.<br>Elongation:<br>Before Aging 500%<br>After Aging 400% min. | After Aging 25.4<br>Mpa, Elongation:<br>Before Aging 508%<br>After Aging 517% | 0 failure Pass | |--|-----------------------|------------|------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------|----------------| | | Powder<br>Free Gloves | ASTM D6124 | Max. 2.0mg | sample quantity:<br>5pcs<br>Average: 0.5mg | Pass | Biocompatibility: 1. ISO 10993-10:2010 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization. 2. ISO 10993-11:2017 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity. 3. ISO 10993-5:2009 Biological evaluation of medical devices - Part 5 Tests for In vitro cytotoxicity | Standard | Test item | Test method | Criteria | Results | |-------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------| | ISO 10993-5:<br>2009 | In Vitro<br>Cytotoxicity | In this study, mammalian L- 929<br>cells were cultured in vitro<br>according to ISO 10993- 5:2009<br>to test the potential cytotoxicity<br>of the test article. The test<br>articles and the control material<br>were separately placed in MEM<br>medium containing 10% fetal<br>bovine serum, and extracted in a<br>37°C incubator for 24 hours.<br>After the end of the extraction,<br>the cell culture medium in the<br>96-well plate (104 cells/well)<br>cultured for 24 hours was<br>removed and replaced with the<br>corresponding extract, cultured<br>in 37°C, 5%<br>CO2, >90% humidity for 24<br>hours. After the culture, the<br>morphology and cell lysis of the<br>cells were observed under the<br>microscope, and the cytotoxicity<br>of the test samples was<br>determined by<br>MTT assay. | The 50% extract of the test<br>article should have at least<br>the same or a higher viability<br>than the 100% extract.<br>Otherwise the test should be<br>repeated.<br>The lower the Viab. % value,<br>the higher the cytotoxic<br>potential of the test article is.<br>If viability is reduced to <70%<br>of the blank, it has a<br>cytotoxic potential.<br>The Viab.% of the 100%<br>extract of the test article is<br>the final result. | Under the condition<br>of the test, the test<br>article was found to<br>be cytotoxic | | ISO 10993<br>-10:<br>2010 | Skin<br>Sensitization | we took guinea pigs to observe<br>the skin sensitization of the test<br>article according to ISO 10993-<br>10: 2010.<br>The test article were extracted<br>in Constant Temperature<br>Vibrator at | Magnusson and Kligman<br>grades of 1 or greater in the<br>test group generally indicate<br>sensitization, provided<br>grades of less than 1 are<br>seen in control animals. | Under the condition<br>of the test, the test<br>article<br>was found to be non- | | | 50°C, 60 rpm for 72 h by<br>0.9 % Sodium Chloride Injection<br>and Sesame Oil. Mix 50:50 (by<br>volume) stable emulsion of<br>Freund's complete adjuvant with<br>selected solvent. Intradermal<br>induction and topical induction<br>were operated in the clipped<br>intrascapular region of each<br>animal. After the topical<br>induction phase was completed<br>on day 14, all test and control<br>animals were challenged with<br>the test sample. The erythema<br>and edema of the challenge site<br>were observed to test the<br>sensitization response of the test<br>article. According to the<br>Magnusson and Kligman scales,<br>the response to erythema and<br>edema at each application site<br>of the skin was described and<br>scored 24<br>hours and 48 hours after the<br>challenge phase. | If grades of 1 or greater are<br>noted in control animals, then<br>the reactions of test animals<br>which exceed the most severe<br>reaction in control animals are<br>presumed to be due to<br>sensitization.<br>If the response is equivocal,<br>rechallenge is recommended<br>to confirm the results from the<br>first challenge. The outcome<br>of the test is presented as the<br>frequency of positive<br>challenge results in test and<br>control animals. | sensitizin g | | | Intracutaneo<br>us reactivity | Within a 4 h to 18 h period<br>before testing, closely clip the fur<br>on the back of the animals,<br>allowing. a sufficient distance on<br>both sides of the spine for<br>injection of the extracts.<br>Use the smallest needle<br>appropriate to the viscosity of<br>the test material for the<br>intradermal injection. Inject<br>intracutaneously 0.2 mL of the<br>extracts obtained with polar<br>solvent at five sites and with<br>non-polar solvent control at<br>another five posterior sites on<br>one side of each rabbit.<br>Similarly, inject 0.2 mL of polar<br>solvent control at five sites and<br>non-polar solvent control at<br>another five posterior sites on<br>the contralateral side of each<br>rabbit. | The requirements of the test<br>are met if the final test article<br>score is 1.0 or less. | the result showed<br>that the polar and<br>non-polar extract of<br>the final test<br>sample score is<br>less 1.0. | | | ISO 10993<br>-11:<br>2017 | Acute<br>systemic<br>toxicity | A single dose of test article<br>extract was injected into the<br>designated group of mice<br>intraperitoneally at the dose level<br>of 50 mL/kg bw. The negative<br>control liquid was injected<br>similarly into the separate group<br>of designated control mice.<br>Mice were observed for any<br>adverse clinical reactions<br>immediately after injection, and<br>then the animals were returned<br>to their cages. The animals<br>were observed for signs of<br>systemic reactions at4,24,48<br>and 72 hours after injection and<br>weighed daily for three days<br>after dosing. Any animal found<br>dead or showed abnormal<br>signs were subjected to gross<br>necropsy. | (1) If during the observation<br>period of an acute systemic<br>toxicity test none of the mice<br>treated with the test article<br>extract exhibited a significantly<br>greater biological reactivity<br>than control mice, the test<br>article met the requirements. If<br>two or more animals died, or if<br>abnormal behavior such as<br>convulsions or prostration<br>occurs in two or more animals,<br>or if body weight loss greater<br>than<br>10 %occurs in three or more<br>animals, the test article did not<br>meet the requirements. (2)If<br>any animals treated with the<br>sample exhibited only slight<br>signs of biological reactivity,<br>and no more than one animal<br>showed gross symptoms of<br>biological reactivity or died,<br>repeat the testing using groups<br>of ten animals. On the repeat<br>test, if all ten animals treated<br>with the test article extract<br>exhibited no scientifically<br>meaningful biological reactivity<br>above the vehicle control<br>animals during the observation<br>period, the test<br>article met the requirements. | Under the condition<br>of the test, the test<br>article was found to<br>be non- systemic<br>toxicity | {8}------------------------------------------------ {9}------------------------------------------------ ### 8. 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.