Hycare Med+ Nitrile Examination Gloves; Hycare Touch Latex Examination Gloves

{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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. December 17, 2021 Hycare International Co., Ltd Sebastian Feye Regulatory Affairs Consultant Accurate Consulting Inc. 3234 Ibis Street San Diego, California 92103 Re: K211209 Trade/Device Name: Hycare Med+ Nitrile Examination Gloves; Hycare Touch Latex Examination Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Non-powdered patient examination glove Regulatory Class: Class I. reserved Product Code: LZA, LYY Dated: November 1, 2021 Received: November 4, 2021 Dear Sebastian Feye: 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 Clarence W. Murray, III, 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 Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below. ## Indications for Use 510(k) Number (if known) K211209 Device Name Hycare Touch Latex Examination Gloves ### Indications for Use (Describe) A patient exammation glove is a disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner. Model LWH-0201 - Latex exammation gloves non-sterile powder-free polymer coated (Ambidextrous) - palm textured -- Color: Natural White - Sizes: X-Small, Small, Medium, Large and X-Large Type of Use (Select one or both, as applicable) | Prescription Use (Part 21 CFR 801 Subpart D) 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." FORM FDA 3881 (6/20) Page 1 of 1 PSC Publishing Services (301) 443-6740 {3}------------------------------------------------ ## DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below. 510(k) Number (if known) K211209 Device Name Hycare Med+ Nitrile Examination Gloves ### Indications for Use (Describe) A patient exammation glove is a disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner. Model NBL-0201 - Nitrile examination gloves non-sterile powder-free (Ambidextrous) - Finger textured - Color: Blue -Sizes: Small, Medium, Large, X-Large and XX Large Type of Use (Select one or both, as applicable) Prescription Use (Part 21 CFR 801 Subpart D) 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." FORM FDA 3881 (6/20) {4}------------------------------------------------ # 510(k) Summary - K211209 ## 1 SUBMITTER: Tippawan Phongpheaw, Assistant Managing Director Hycare International Co., Ltd 1197 Moo 3, Asia Highway, Khuanlang Hatyai Songkhla, 90110 Thailand Establishment Registration Number: None ## Primary Contact: Sebastian Feye, Regulatory Affairs Consultant Accurate Consultants Inc. 3234 Ibis Street San Diego, CA, 92103 Telephone: 619-517-0673 sebastian@accuratefdaconsulting.com Date Prepared: 12/16/2021 #### DEVICE: വ ## Name of Device Candidate #1: 1) Hycare Med+ Nitrile Examination Gloves Common or Usual Name: Exam Gloves Classification Name: Patient Examination Gloves (21 CFR 880.6250) Regulatory Class: 1, reserved Product code: LZA ## Name of Device Candidate #2: 2) Hycare Touch Latex Examination Gloves Common or Usual Name: Exam Gloves Classification Name: Patient Examination Gloves (21 CFR 880.6250) Regulatory Class: 1, reserved {5}------------------------------------------------ #### ന PREDICATE DEVICES: | Candidate #1 | Primary<br>Predicate | Manufacturer | Docket<br>Number | |----------------------------------------------|---------------------------------------------------|----------------------------------------------|------------------| | Hycare Med+<br>Nitrile Examination<br>Gloves | Powder Free<br>Nitrile Patient<br>Exam<br>Gloves, | Tangshan Zhonghong<br>Pulin Plastic Co., Ltd | K120970 | | Candidate #2 | Primary<br>Predicate | Manufacturer | Docket<br>Number | |---------------------------------------------|-----------------------------------------------------------------------------------|----------------------------------|------------------| | Hycare Touch<br>Latex Examination<br>Gloves | Powder Free<br>Latex Exam<br>Glove, with<br>Protein Labeling<br>(50 ug/g or less) | Hycare International<br>Co., Ltd | K020042 | #### DEVICE DESCRIPTION: 4. Two subject devices are bundled into this 510(k) submission. The first is a Hycare Med+ Nitrile Examination Gloves, blue colored, non-sterile called Hycare Med+ Nitrile Examination Gloves and the second is Hycare Touch Latex Examination Gloves, Natural White, Non-Sterile with Protein Labeling Claim (50 ug/g or less) called Hycare Touch Latex Examination Gloves. The principal operation both types of patient exam gloves are to provide single use barrier protection for the wearer and each device meets all the appropriate requirement specifications for Barrier Protection and tensile properties as defined in ASTM D6319-10, Standard Specification for Nitrile Examination Gloves and ASTM D3578-19, Standard Specification for Rubber Examination Gloves. The following models are disposable, single-use examination gloves (in boxes of 50, 100 and 200) which are included in this submission: | Models | Description | Length | Color | Sizes | |--------|-------------|--------|-------|-------| |--------|-------------|--------|-------|-------| {6}------------------------------------------------ | | Hycare Touch Latex Examination Gloves | | | | |----------|---------------------------------------------------------------------------------------------------|------------|------------------|------------------| | | Latex examination gloves non-sterile powder-free<br>polymer coated (Ambidextrous) – palm textured | | Natural<br>white | | | LWH-0201 | | min 240 mm | | XS,S,M,L,XL | | | Hycare Med+ Nitrile Examination Gloves | | | | | | Nitrile examination gloves non-sterile powder-free<br>(Ambidextrous) - Finger textured | | Blue | S,M,L,XL,<br>XXL | | NBL-0201 | | min 240 mm | | | #### 5 INDICATIONS FOR USE: A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner. ### 6 COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE: The following tables compares each subject device and it's predicate device, that are identified in Section 3.0 of this summary: ## Candidate #1 | Characteristics | Subject device,<br>Hycare Med+ Nitrile<br>Examination Gloves | Predicate Device<br>Tangshan Zhonghong Pulin<br>Plastic Co. Powder- Free<br>Nitrile Patient Exam<br>Glove | Comments | |----------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------| | 510k | K211209 | K120970 | Different | | Product Code | LZA | LZA | Same | | Intended Use | A patient examination glove<br>is a disposable device<br>intended for medical<br>purposes that is worn on the<br>examiner's hands or finger to<br>prevent contamination<br>between patient and<br>examiner. | A patient examination glove<br>is a disposable device<br>intended for medical<br>purposes that is worn on the<br>examiner's hands or finger to<br>prevent contamination<br>between patient and<br>examiner. | Same | | Material Use | Nitrile Compound | Nitrile Compound | Same | | Color | Blue | Blue | Same | | Sterility | Non-sterile | Non-sterile | Same | | Dimensions | Overall Length (mm)<br>Min 230mm Width (±<br>10mm) Size S = 80mm<br>Size M= 95mm Size L<br>= 110mm Size<br>XL = 120mm XXL = 130 mm<br>Thickness at Palm<br>(mm)<br>Min; 0.05 mm<br>Thickness at Finger Tip<br>(mm) Min 0.05 mm | Overall Length (mm)<br>Min 230mm Width (±<br>10mm) Size S = 80mm<br>Size M= 95mm Size L<br>= 110mm Size<br>XL = 120mm<br>Thickness at Palm<br>(mm)<br>Min; 0.05 mm<br>Thickness at Finger Tip<br>(mm) Min 0.05 mm | Meets ASTM<br>D6319-10 | | Physical<br>Properties | Before Ageing Tensile<br>Strength (MPa) = 14 min<br>Ultimate Elongation (%)<br>= 500 min<br>After Aging at 70°C for 168<br>hrs @ 100°C for<br>22 hrs Tensile Strength<br>(MPa) = 14 min Ultimate<br>Elongation (%) = 400 min | Before Ageing Tensile<br>Strength (MPa) = 14 min<br>Ultimate Elongation (%)<br>= 500 min<br>After Aging at 70°C for 168<br>hrs @ 100°C for<br>22 hrs Tensile Strength<br>(MPa) = 14 min Ultimate<br>Elongation (%) = 400 min | Meets ASTM<br>D6319-10 | | Freedom from<br>Pinholes | AQL 2.5<br>Inspection Level G-1 | AQL 2.5<br>Inspection Level G-1 | Meets ASTM<br>D5151-<br>19 | | Residual Powder | < 2.0 mg/dm2 | < 2.0 mg/dm2 | Meets ASTM<br>D6124-<br>06 | | Biocompatibility -<br>ISO 10993-10-<br>-Primary Skin<br>Irritation<br>Test | Under the conditions of<br>this study, the test<br>article was a nonirritant. | Under the conditions of<br>this study, the test<br>article was a nonirritant. | Meets<br>ISO 10993-10 | | ISO 10993-10-<br>Dermal<br>Sensitization<br>Assay | Under the conditions of<br>this study, the test<br>article was a non-sensitizer. | Under the conditions of<br>this study, the test<br>article was a non-sensitizer. | Meets<br>ISO 10993-10 | | ISO 10993-5<br>Biological<br>evaluation of<br>medical devices --<br>Part 5: Tests for In<br>Vitro cytotoxicity | Under the conditions of this<br>study, the test article was<br>cytotoxic; does not meet ISO<br>10993-5 | Did not conduct this testing | Different | | ISO 10993-11-<br>Systemic Toxicity | Under the conditions of this<br>study, the test article did not<br>induce systemic toxicity;<br>meets ISO 10993-11 | Did not conduct this testing | Different | | Labeling for the<br>legally marketed<br>device to which<br>substantial<br>equivalence is<br>claimed | Powder Free<br>-Patient Examination<br>Glove<br>-Single Use Only<br>- Manufactured For:<br>- Lot<br>-Blue color<br>- Non-sterile | Powder Free<br>-Patient Examination<br>Glove<br>-Single Use Only<br>- Manufactured For:<br>- Lot<br>-Blue color<br>- Non-sterile | Same | {7}------------------------------------------------ {8}------------------------------------------------ There are no significant differences between the Hycare International Nitrile examination gloves non-sterile powder-free and the predicate, Tangshan Zhonghong Pulin Plastic Co Powder-Free Nitrile Patient Examination Gloves. (K120970) ## Candidate #2 | Characteristics | Subject device,<br>Hycare Touch Latex<br>Examination Gloves | Predicate Device<br>Hycare International Co., Ltd<br>Powder-Free Latex Exam<br>Gloves With Protein Labeling<br>(50 ug/g or less | Comments | |----------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------| | 510k | K211209 | K020042 | Different | | Product Code | LYY | LYY | Same | | Intended Use | A patient examination glove<br>is a disposable device<br>intended for medical<br>purposes that is worn on the<br>examiner's hands or finger to<br>prevent contamination<br>between patient and<br>examiner. | A patient examination glove<br>is a disposable device<br>intended for medical<br>purposes that is worn on the<br>examiner's hands or finger to<br>prevent contamination<br>between patient and<br>examiner. | Same | | Material Use | Rubber (Latex) Compound | Rubber (Latex) Compound | Same | | Color | Natural White | Natural White | Same | | Sterility | Non-sterile | Non-sterile | Same | | Dimensions | Overall Length (mm)<br>Min 220-230 mm<br>Width (± 10 mm) Size XS =<br>70mm Size S = 80mm<br>Size M= 95mm Size L<br>= 110mm Size<br>XL = 120 mm<br>Thickness at Palm<br>(mm)<br>Min; 0.08 mm<br>Thickness at Finger Tip<br>(mm) Min 0.08 mm | Overall Length (mm)<br>Min 220-230 mm<br>Width (± 10 mm) Size XS =<br>70mm Size S = 80mm<br>Size M= 95mm Size L<br>= 110mm Size<br>XL = 120 mm<br>Thickness at Palm<br>(mm)<br>Min; 0.08+ mm<br>Thickness at Finger Tip<br>(mm) Min 0.08 mm | Meets ASTM<br>D3578-19 | | Physical<br>Properties | Before Aging Tensile<br>Strength (MPa) = 18min<br>Ultimate Elongation (%)<br>= 650min<br>Stress at 500% elongation =<br>max 5.5 MPa<br>After Aging at 70°C for 168<br>hrs @ 100°C for<br>22 hrs Tensile Strength<br>(MPa) = 14min Ultimate<br>Elongation (%) = 500min | Before Aging Tensile<br>Strength (MPa) = 18min<br>Ultimate Elongation (%)<br>= 650min<br>Stress at 500% elongation =<br>max 5.5 MPa<br>After Aging at 70°C for 168<br>hrs @ 100°C for<br>22 hrs Tensile Strength<br>(MPa) = 14min Ultimate<br>Elongation (%) = 500min | Meets ASTM<br>D3578-19 | | Freedom from<br>Pinholes | AQL 2.5<br>Inspection Level G-1 | AQL 2.5<br>Inspection Level G-1 | Meets ASTM<br>D5151-<br>19 | | Residual Powder | < 2.0 mg/dm² | < 2.0 mg/dm² | Meets ASTM<br>D6124-<br>06 | | Biocompatibility -<br>ISO 10993-10-<br>-Primary Skin<br>Irritation<br>Test | Under the conditions of<br>this study, the test<br>article was a nonirritant. | Under the conditions of<br>this study, the test<br>article was a nonirritant. | Meets<br>ISO 10993-10 | | ISO 10993-10-<br>Dermal<br>Sensitization<br>Assay | Under the conditions of<br>this study, the test<br>article was a non-sensitizer. | Under the conditions of<br>this study, the test<br>article was a non-sensitizer. | Meets<br>ISO 10993-10 | | ISO 10993-5<br>Biological<br>evaluation of<br>medical devices --<br>Part 5: Tests for In<br>Vitro cytotoxicity | Under the conditions of this<br>study, the test article was<br>cytotoxic; does not meet ISO<br>10993-5 | Did not conduct this testing | Different | | ISO 10993-11-<br>Systemic Toxicity | Under the conditions of this<br>study, the test article did not<br>induce systemic toxicity;<br>meets ISO 10993-11 | Did not conduct this testing | Different | | Labeling for the<br>legally marketed<br>device to which<br>substantial<br>equivalence is<br>claimed | Powder Free<br>-Patient Examination<br>Glove<br>-Single Use Only<br>- Manufactured For:<br>- Lot<br>-Natural White<br>- Non-sterile | Powder Free<br>-Patient Examination<br>Glove<br>-Single Use Only<br>- Manufactured For:<br>- Lot<br>-Natural White<br>- Non-sterile | Same | {9}------------------------------------------------ There are no differences between the Hycare Touch Latex Examination Gloves and the predicate device, Hycare International Co., Ltd Powder-Free Latex Exam Gloves with Protein Labeling (50 ug/g or less (K020042). {10}------------------------------------------------ #### SUMMARY OF NON-CLINICAL TESTING RESULTS 7 Candidate #1 Hycare Med+ Nitrile Examination Gloves was tested and conformed to the following standards: | Test Title | Purpose of Test | Acceptance Criteria | Results | |-------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------| | ASTM D6319-10<br>Standard<br>Specification for<br>Nitrile Examination<br>Gloves for Medical<br>Application | To determine<br>tensile strength<br>and elongation of<br>gloves | Before Aging: 14 MPa min<br>Tensile, 500% Elongation<br>After Aging: 14 MPa min<br>Tensile, 400% Elongation | Met<br>acceptance<br>criteria after<br>Aging at<br>70°C for<br>168 hrs @<br>100°C for<br>22 hrs, Pass | | ASTM D5151<br>Standard Test<br>Method for detection<br>of Holes in Medical<br>Gloves | Pinhole testing<br>with limited<br>number of<br>rejections to<br>ensure physical<br>strength | Inspection level G-1, AQL<br>2.5, reject max of 22<br>samples | 19 rejects<br>detected,<br>under 22 by<br>AQL<br>standards,<br>Pass | | D6124-06 Standard<br>Test Method for<br>Residual Powder on<br>Medical Gloves | To determine<br>residual powder on<br>gloves to ensure<br>under 2.0 mg limit | Residue limit < 2.0 mg on<br>all sizes | All powder<br>residue on<br>all sizes<br>was <<br>2.0mg, Pass | | ISO 10993-10<br>Biological evaluation<br>on medical device<br>Part 10: Test for<br>irritation and Skin<br>Sensitization | To determine<br>irritation and skin<br>sensitization<br>reactions if any | Sensitization: Grades of<br><1, no evidence of<br>sensitization<br>Skin Irritation: Test sites<br>should not exceed control<br>site grade | Grade 0 for<br>all tests,<br>Pass | | ISO 10993-5<br>Biological evaluation<br>of medical devices -<br>Part 5: Tests for In<br>Vitro cytotoxicity | To determine if<br>text article is<br>cytotoxic | Cytotoxicity Grade < 2 at<br>undiluted extraction<br>Non-Toxic to L-929 cells | Cytotoxic at<br>undiluted<br>extraction,<br>Failed | {11}------------------------------------------------ | Test Title | Purpose of Test | Acceptance Criteria | Results | |--------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Biological<br>Evaluation of<br>Medical Devices -<br>Part 11, Tests for<br>Systemic Toxicity,<br>ISO 10993-11 | To determine if<br>test article does<br>not induce<br>systemic toxicity | 1. None of the animals<br>treated with test item<br>should show a significantly<br>greater biological reactivity<br>than animals treated with<br>solvent control.<br>2. None of the animals in<br>the control group should<br>show significant loss of<br>body weight greater than<br>10%.<br>3. No mortality or abnormal<br>behavior such as<br>convulsions or prostration<br>should occur in control<br>group animals. | No mortality<br>or morbidity<br>observed,<br>gradual<br>increase in<br>body weight<br>and no<br>signs of ill<br>health or<br>toxicity was<br>observed,<br>Passed | ## Candidate #2 Hycare Touch Latex Examination Gloves was tested and conformed to the following standards: | Test Title | Purpose of Test | Acceptance Criteria | Results | |--------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------| | ASTM D3578-19<br>Standard<br>Specification for<br>Rubber Examination<br>Gloves | To determine<br>tensile strength<br>and elongation of<br>gloves | Before Aging: 18 MPa min<br>Tensile, 650% Elongation,<br>5.5 MPa max at 500%<br>Elongation<br>After Aging: 14 MPa min<br>Tensile, 500% Elongation | Met<br>acceptance<br>criteria after<br>Aging at<br>70oC for<br>168 hrs @<br>100oC for<br>22 hrs, Pass | | ASTM D5151<br>Standard Test<br>Method for detection<br>of Holes in Medical<br>Gloves | Pinhole testing<br>with limited<br>number of<br>rejections to<br>ensure physical<br>strength | Inspection level G-1, AQL<br>2.5 | 13 rejects<br>detected,<br>under 22 by<br>AQL<br>standards,<br>Pass Pass | | D6124-06 Standard<br>Test Method for<br>Residual Powder on<br>Medical Gloves | To determine<br>residual powder on<br>gloves to ensure<br>under 2.0 mg limit | Residue limit < 2.0 mg on<br>all sizes | All powder<br>residue on<br>all sizes<br>was <<br>2.0mg, Pass | {12}------------------------------------------------ | Test Title | Purpose of Test | Acceptance Criteria | Results | |-------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------| | ISO 10993-10<br>Biological evaluation<br>on medical device<br>Part 10: Test for<br>irritation and Skin<br>Sensitization | To determine<br>irritation and skin<br>sensitization<br>reactions if any | Sensitization: Grades of<br><1, no evidence of<br>sensitization<br>Skin Irritation: Test sites<br>should not exceed control<br>site grade | Grade 0 for<br>all tests,<br>Pass | | ISO 10993-5<br>Biological evaluation<br>of medical devices -<br>Part 5: Tests for In<br>Vitro cytotoxicity | To determine if<br>text article is<br>cytotoxic | Cytotoxicity Grade <2 at<br>undiluted extraction<br>Non-Toxic to L-929 cells | Cytotoxic at<br>undiluted<br>extraction,<br>Failed | | Biological<br>Evaluation of<br>Medical Devices -<br>Part 11, Tests for<br>Systemic Toxicity,<br>ISO 10993-11 | To determine if<br>test article does<br>not induce<br>systemic toxicity | 1. None of the animals<br>treated with test item<br>should show a significantly<br>greater biological reactivity<br>than animals treated with<br>solvent control.<br>2. None of the animals in<br>the control group should<br>show significant loss of<br>body weight greater than<br>10%.<br>3. No mortality or abnormal<br>behavior such as<br>convulsions or prostration<br>should occur in control<br>group animals. | No mortality<br>or morbidity<br>observed,<br>gradual<br>increase in<br>body weight<br>and no<br>signs of ill<br>health or<br>toxicity was<br>observed,<br>Passed | #### 8 SUMMARY OF CLINICAL PERFORMANCE TESTING: N/A Not applicable for this device. ## CONCLUSIONS: The conclusions drawn from the nonclinical tests that demonstrate that the two devices in this submission, Hycare Med+ Nitrile Examination Gloves (Candidate #1) and the Hycare Touch Latex Examination Gloves (Candidate #2) is as safe, as effective, and performs as well as or better than the legally marketed device.