First Glove Blue Nitrile Examination Gloves Powder Free

{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. May 30, 2023 First Glove Sdn. Bhd. % Manoj Zacharias Consultant Liberty Management Group Ltd. 75 Executive Dr. Ste 114 Aurora, Illinois 60504 Re: K230958 Trade/Device Name: First Glove Blue Nitrile Examination Gloves Powder Free Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I. reserved Product Code: LZA Dated: March 13, 2023 Received: April 4, 2023 Dear Manoj Zacharias: 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. # Bifeng Qian -S Bifeng Oian, 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 Quality Center for Devices and Radiological Health {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K230958 #### Device Name First Glove Blue Nitrile Examination Gloves Powder Free #### Indications for Use (Describe) First Glove Blue Nitrile Examination Gloves Powder Free is a 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) | | |--------------------------------------------------------------|-------------------------------------------------------------| | <span></span> ☐ Prescription Use (Part 21 CFR 801 Subpart D) | <span></span> ☑ 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 K230958 AS REQUIRED BY: 21CFR§807.92 ## A. APPLICANT INFORMATION | 510(K) Owner's Name | FIRST GLOVE SDN. BHD. | |---------------------|---------------------------------------------------------------------------------------------------------------| | Address | Unit 23-2, Level 23, Binjai 8, No. 2, Lorong Binjai,<br>Kuala Lumpur, Wilayah Persekutuan, Malaysia<br>50450. | | Phone | +60 12-389 1644, +603 2181 8201 | | Fax | +603 2181 7201 | | E-mail | dean@firstglove.com, | | Contact Person | Mr. Dean Segal | | Designation | President | | Contact Number | +60 12-389 1644 | | Contact Email | dean@firstglove.com | | Date Submitted | 13 March 2023 | ## B. DEVICE IDENTIFICATION | Name of the device | First Glove Blue Nitrile Examination Gloves Powder<br>Free | |-----------------------------------|------------------------------------------------------------| | Product proprietary or trade name | First Glove | | Common or usual name | Blue Nitrile Examination Gloves Powder Free | | Classification name | Non-powdered patient examination glove | | Device Classification | Class-1 | | Product Code | LZA | | Regulation Number | 21 CFR 880.6250 | | Review Panel | General Hospital | ## C. PREDICATE DEVICE | Predicate Device | Palm Care Blue Nitrile Examination Gloves Powder free | |------------------|-------------------------------------------------------| | 510(k) Number | K202384 | | Regulatory Class | Class 1 | | Product code | LZA | | Reference Device | Nitrile Patient Examination Gloves | |------------------|------------------------------------| | 510(k) Number | K211351 | | Regulatory Class | Class 1 | | Product code | LZA | {4}------------------------------------------------ # 510(K) SUMMARY AS REQUIRED BY: 21CFR§807.92 ### D. DESCRIPTION OF THE DEVICE: First Glove Blue Nitrile Examination Gloves Powder Free are equivalent to Class I patient examination gloves bearing the product code LZA (21CFR880.6250). They meet all the current specifications listed under the ASTM D6319-19, Standard Specification for Nitrile Examination Gloves for Medical Application. They are made from Nitrile (NBR)100%. These gloves are blue in color and are powder free. The product is non-sterile, finger textured, ambidextrous with beaded cuff and single use only. First Glove Blue Nitrile Examination Gloves Powder Free with sizes Extra Small, Small, Medium, Large, Extra Large and Extra Extra Large are included in the submission. ### E. INDICATIONS FOR USE OF THE DEVICE: First Glove Blue Nitrile Examination Gloves Powder Free is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. ### F.SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED TO THE PREDICATE DEVICE | CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE | | | COMPARISON | |---------------------|------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------| | | | PREDICATE | REFERENCE | SUBJECT | | | 510(k) Number | --- | K202384 | K211351 | K230958 | --- | | Name of device | --- | Palm Care Blue<br>Nitrile<br>Examination<br>Gloves Powder<br>free | Nitrile Patient<br>Examination<br>Gloves | First Glove Blue<br>Nitrile Examination<br>Gloves Powder<br>Free | --- | | Product Code | --- | LZA | LZA | LZA | Same | | Indications for Use | --- | Blue Nitrile<br>Examination<br>Gloves Powder<br>Free is disposable<br>devices intended<br>for medical<br>purpose that are<br>worn on the<br>examiner's hand<br>to prevent<br>contamination<br>between patient<br>and examiner. | The Nitrile<br>Patient<br>Examination<br>Gloves are non-<br>sterile disposable<br>devices intended<br>for medical purposes<br>that are worn on<br>the examiner's<br>hands or finger to<br>prevent<br>contamination<br>between patient<br>and examiner. | First Glove Blue<br>Nitrile<br>Examination<br>Gloves Powder<br>Free is a disposable<br>device intended for<br>medical purpose<br>that is worn on the<br>examiner's hand to<br>prevent<br>contamination<br>between patient<br>and examiner. | Same | | Regulation Number | --- | 21 CFR 880.6250 | 21 CFR 880.6250 | 21 CFR 880.6250 | Same | | Material | ASTM<br>D6319-19 | Nitrile (NBR) | Nitrile | Nitrile (NBR) | Same | | Color | --- | Blue | Blue | Blue | Same | | Texture | --- | Finger Texture | --- | Finger Texture | Same as<br>predicate<br>device | {5}------------------------------------------------ # | CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE | | | COMPARISON | | | | | | | | | | | | | | | |------------------------------------------|----------------------------------------|-------------------------------------------------|-------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------|--|--|--|--|--|--|--|--|--|--|--|------|--|--------------------------| | | | PREDICATE | REFERENCE | SUBJECT | | | | | | | | | | | | | | | | | 510(k) Number | --- | K202384 | K211351 | K230958 | --- | | | | | | | | | | | | | | | | Size | ASTM<br>D6319-19 | Extra Small, Small, Medium, Large, Extra Large | XS, S, M, L, XL, XXL | XS, S, M, L, XL, XXL | Same as reference device | | | | | | | | | | | | | | | | Design Feature | --- | Ambidextrous | Ambidextrous | Ambidextrous | Same | | | | | | | | | | | | | | | | Single Use | Medical Glove Guidance Manual-Labeling | Single Use | Single Use | Single Use | Same | | | | | | | | | | | | | | | | Sterile/non sterile | --- | Nonsterile | Non-Sterile | Nonsterile | Same | | | | | | | | | | | | | | | | Powder/Powder free | --- | Powder free | Powder free | Powder free | Same | | | | | | | | | | | | | | | | Dimensions- Length | ASTM<br>D6319-19 | Length Min 230 mm<br>(for medium size) | Length (mm):<br>XS/S:≥220;<br>M/L/XL/XXL:<br>≥230 | Length (mm):<br>XS/S:≥220;<br>M/L/XL/XXL:<br>≥230<br>Size Average XS 247.00 S 247.23 M 252.54 L 250.92 XL 245.54 XXL 251.00 | | | | | | | | | | | | | | | Same as reference device | | Dimensions- Width | ASTM<br>D6319-19 | Width Min 95+/-<br>10mm<br>(for medium size) | Width (mm):<br>XS:70±10;<br>S:80±10;<br>M:95±10;<br>L:110±10;<br>XL:120±10;<br>XXL:130±10 | Width (mm):<br>XS:70±10;<br>S:80±10;<br>M:95±10;<br>L:110±10;<br>XL:120±10;<br>XXL:130±10<br>Size Average XS 74.31 S 85.08 M 94.85 L 105.38 XL 110.77 XXL 121.31 | | | | | | | | | | | | | | | Same as reference device | | Physical Properties-<br>Tensile Strength | ASTM<br>D6319-19 | Before Ageing<br>Tensile Strength<br>Min 14 MPa | Before Ageing<br>Tensile<br>Strength<br>14MPa, min | Before Ageing<br>Tensile Strength<br>Min 14 MPa<br>Size Average XS 35.25 S 29.47 M 27.72 L 30.12 XL 36.26 | | | | | | | | | | | | | Same | | | {6}------------------------------------------------ # | CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE | | | COMPARISON | | | | | | | | | | | | | | | | | | | | | | |---------------------------------------------|------------------|-----------------------------------------------------|--------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|--|--|--|--|--|--|--|--|--|--|--|--|--|------|--|--|--|--|--|--|------| | | | PREDICATE | REFERENCE | SUBJECT | | | | | | | | | | | | | | | | | | | | | | | | 510(k) Number | | K202384 | K211351 | K230958 | | | | | | | | | | | | | | | | | | | | | | | | Physical Properties-<br>Tensile Strength | ASTM<br>D6319-19 | After Ageing<br>Tensile Strength<br>Min14 MPa | After Ageing<br>Tensile<br>Strength<br>14MPa, min | After Ageing<br>Tensile Strength<br>Min 14 MPa<br>Size Average XS 35.75 S 30.02 M 28.75 L 29.55 XL 31.20 XXL 35.66 | | | | | | | | | | | | | | | Same | | | | | | | | | Physical Properties-<br>Ultimate Elongation | ASTM<br>D6319-19 | Before Ageing<br>Ultimate<br>Elongation<br>Min 500% | Before Ageing<br>Ultimate<br>Elongation<br>500% min | Before Ageing<br>Ultimate Elongation<br>Min 500%<br>Size Average XS 537 S 525 M 525 L 523 XL 528 XXL 533 | | | | | | | | | | | | | | | Same | | | | | | | | | Physical Properties-<br>Ultimate Elongation | ASTM<br>D6319-19 | After Ageing<br>Ultimate<br>Elongation<br>Min 400% | After Ageing<br>Ultimate<br>Elongation<br>400% min | After Ageing<br>Ultimate Elongation<br>Min 400%<br>Size Average XS 493 S 478 M 516 L 495 XL 485 XXL 502 | | | | | | | | | | | | | | | Same | | | | | | | | | Thickness | ASTM<br>D6319-19 | Palm Min<br>0.05mm<br>Finger Min<br>0.05mm | Thickness<br>(mm):<br>Palm: ≥0.05<br>Finger: ≥0.05 | Palm Min 0.05 mm<br>Finger Min 0.05mm<br>Size Palm<br>(Avg)<br>mm Finger<br>(Avg)<br>mm XS 0.07 0.10 S 0.06 0.10 M 0.07 0.10 L 0.06 0.10 XL 0.07 0.11 XXL 0.07 0.10 | | | | | | | | | | | | | | | | | | | | | | Same | | Powder Free Residue | ASTM<br>D6319-19 | ≤2 mg/glove | Meet the<br>requirements<br>of ASTM<br>D6124<br><2.0mg | ≤2 mg/glove<br>Size Average XS 0.04 mg/glove S 0.28 mg/glove M 0.04 mg/glove L 0.04 mg/glove XL 0.26 mg/glove XXL 0.48 mg/glove | | | | | | | | | | | | | | | Same | | | | | | | | {7}------------------------------------------------ # 510(K) SUMMAR AS REQUIRED BY: 21CFR§807.92 | CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE | | | COMPARISON | |-----------------------|---------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------| | | | PREDICATE | REFERENCE | SUBJECT | | | 510(k) Number | --- | K202384 | K211351 | K23958 | | | Freedom from<br>Holes | ASTM<br>D5151-19 | Passes AQL - 1.5 | Be free from<br>holes when<br>tested in<br>accordance<br>with ASTM<br>D5151<br>AQL=2.5 | Passes AQL - 2.5 | Similar to<br>reference device | | Biocompatibility | Primary Skin<br>Irritation- ANSI<br>AAMI ISO<br>10993-<br>10:2010/(R)2014 | Under the<br>condition of<br>study, not an<br>irritant | Under the<br>conditions of<br>the study, not<br>an irritant or a<br>sensitizer. | Under the<br>condition of the<br>study, the test<br>article is<br>considered a non-<br>irritant. | Same | | | Dermal<br>Sensitization-<br>ANSI AAMI<br>ISO 10993-<br>10:2010/(R)2014 | Under the<br>conditions of the<br>study, not a<br>sensitizer | Under<br>conditions of<br>the study, not a<br>sensitizer. | Under the<br>conditions of the<br>study, the test<br>article is not<br>considered to be a<br>contact sensitizer. | Same | | | In vitro<br>cytotoxicity-<br>ANSI AAMI<br>ISO 10993-<br>5:2009/(R)2014 | Under the<br>conditions of the<br>study, non-<br>cytotoxic | Under<br>conditions of<br>the study, did<br>not show<br>potential<br>toxicity to L-<br>929 cells. | Under the<br>conditions of the<br>study, the test<br>article is<br>considered<br>cytotoxic at extract<br>concentrations of<br>100%, 66.7%,<br>44.4%, 29.6% and<br>19.8% and did not<br>produce a cytotoxic<br>effect at 13.2%.<br>Moreover, under<br>the conditions of<br>the study, non<br>acute systemic<br>toxic. | Similar | | | Acute Systemic<br>Toxicity-ANSI<br>AAMI ISO<br>10993-11:2017 | Under the<br>conditions of<br>study, the device<br>extracts do not<br>pose a systemic<br>toxicity | --- | Under the<br>condition of study,<br>the test article did<br>not induce any<br>systemic toxicity. | Same as<br>predicate device | There are no significant differences between the products and are identical in terms of intended use materials, design and manufacturing methods. Devices meet the ASTM standard D6319-19. {8}------------------------------------------------ ## 510(K) SUMMARY AS REQUIRED BY: 21CFR§807.92 ## G. SUMMARY OF NON-CLINICAL PERFORMANCE TESTING | TEST METHOD | PURPOSE | ACCEPTANCE<br>CRITERIA | RESULT | | | | | | | | | | | | | | | | | | | | | | |----------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--| | ASTM D6319-19<br>Standard Specification<br>for Nitrile Examination<br>Gloves for Medical<br>Application. | To determine<br>the length of the<br>gloves | X-Small : 220 mm min<br>Small : 220 mm min<br>Medium : 230 mm min<br>Large : 230 mm min<br>X-Large : 230 mm min<br>XX-Large : 230 mm min | XS: - 247.00 mm<br>S: - 247.23 mm<br>M: - 252.54 mm<br>L: - 250.92 mm<br>XL: - 245.54 mm<br>XXL: - 251.00 mm | | | | | | | | | | | | | | | | | | | | | | | ASTM D6319-19<br>Standard Specification<br>for Nitrile Examination<br>Gloves for Medical<br>Application. | To determine<br>the width of the<br>gloves | XS: 70+/-10 mm<br>S: 80+/-10 mm<br>M: 95+/-10 mm<br>L: 110+/-10 mm<br>XL: 120+/-10 mm<br>XXL: 130+/-10 mm | XS: - 74.31 mm<br>S: - 85.08 mm<br>M: - 94.85 mm<br>L: - 105.38 mm<br>XL: - 110.77 mm<br>XXL: - 121.31 mm | | | | | | | | | | | | | | | | | | | | | | | ASTM D6319-19<br>Standard Specification<br>for Nitrile Examination<br>Gloves for Medical<br>Application. | To determine<br>the thickness of<br>the gloves | Palm<br>0.05 mm min (for all<br>sizes)<br>Finger<br>0.05 mm min (for all<br>sizes) | Size Palm(mm) Finger(mm) XS 0.07 0.10 S 0.06 0.10 M 0.07 0.10 L 0.06 0.10 XL 0.07 0.11 XXL 0.07 0.10 | | | | | | | | | | | | | | | | | | | | | | | ASTM D6319-19<br>Standard Specification<br>for Nitrile Examination<br>Gloves for Medical<br>Application. | To determine<br>the physical<br>properties-<br>Tensile strength | Before Ageing<br>Tensile Strength 14MPa<br>Min for all sizes<br>After Ageing<br>Tensile Strength 14MPa<br>Min for all sizes | Size Before<br>Ageing After<br>ageing XS 35.25 MPa 35.75 MPa S 29.47 MPa 30.02 MPa M 27.72 MPa 28.75 MPa L 30.12 MPa 29.55 MPa XL 36.26 MPa 31.20 MPa XXL 33.60 MPa 35.66 MPa | | | | | | | | | | | | | | | | | | | | | | | | To determine<br>the physical<br>properties-<br>Ultimate<br>Elongation | Before Ageing<br>Ultimate Elongation<br>500% Min for all sizes<br>After Ageing<br>Ultimate Elongation<br>400% Min for all sizes | Size Before<br>Ageing After<br>Ageing XS 537 % 493 % S 525 % 478 % M 525 % 516 % L 523 % 495 % XL 528 % 485 % XXL 533 % 502 % | | | | | | | | | | | | | | | | | | | | | | | ASTM D5151-19<br>Standard Test Method<br>for Detection of Holes<br>in Medical Gloves | To determine the<br>holes in the<br>gloves | AQL 2.5 | Gloves Passes AQL 2.5 | | | | | | | | | | | | | | | | | | | | | | | ASTM D6124-06<br>(Reapproved 2017)<br>Standard Test Method<br>for Residual Powder on<br>Medical Gloves | To determine the<br>residual powder<br>in the gloves | ≤ 2 mg/glove | XS: - 0.04 mg/glove<br>S: - 0.28 mg/glove<br>M: - 0.04 mg/glove<br>L: - 0.04 mg/glove<br>XL: - 0.26 mg/glove<br>XXL: - 0.48 mg/glove | | | | | | | | | | | | | | | | | | | | | | ## BENCH TEST DATA {9}------------------------------------------------ # AS REQUIRED BY: 2 ### BIOCOMPATIBILITY DATA | TEST METHOD | PURPOSE | ACCEPTANCE<br>CRITERIA | RESULT | |----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | ANSI AAMI ISO 10993-<br>10:2010/(R)2014 - Biological<br>evaluation of medical devices<br>- Part 10: Tests for irritation<br>and skin sensitization<br>Test done for irritation | To evaluate the test item,<br>for skin irritation test in<br>New Zealand Albino<br>Rabbits. | Under the condition of<br>study not an irritant | Under the condition of the<br>study, the test article is<br>considered a non-irritant. | | ANSI AAMI ISO 10993-<br>10:2010/(R)2014 - Biological<br>evaluation of medical devices<br>- Part 10: Tests for irritation<br>and skin sensitization<br>Test done for skin sensitization | To evaluate the test item,<br>for the skin sensitization<br>in Guinea pigs by<br>maximization test. | Under the conditions<br>of the study, not a<br>sensitizer | Under the conditions of the<br>study, the test article is not<br>considered to be a contact<br>sensitizer. | | ANSI AAMI ISO 10993-<br>5:2009/(R)2014 - Biological<br>evaluation of medical devices<br>-Part 5: Tests for in vitro<br>cytotoxicity | To evaluate the test item,<br>for its ability to induce<br>cytotoxicity using mouse<br>cell line L929 by XTT<br>Dye Method. | Under the conditions<br>of the study, non-<br>cytotoxic | Under the conditions of the<br>study, the test article is<br>considered cytotoxic at<br>extract concentrations of<br>100%, 66.7%, 44.4%,<br>29.6% and 19.8% and did<br>not produce a cytotoxic<br>effect at 13.2%.<br>Moreover, under the<br>conditions of the study, non<br>acute systemic toxic. | | ANSI AAMI ISO 10993-<br>11:2017 - Biological<br>evaluation of medical devices<br>- Part 11: Tests for systemic<br>toxicity | To evaluate the test item,<br>for acute systemic<br>toxicity in Albino CD-1<br>Mouse. | Under the conditions<br>of study, the device<br>extracts do not pose a<br>systemic toxicity<br>concern | Under the condition of<br>study, the test article did<br>not induce any systemic<br>toxicity. | ### The performance test data of the non-clinical tests meet the following standards: ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application. 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 ANSI AAMI ISO 10993-10:2010/(R)2014 Biological Evaluation of Medical Devices - Part 10: Tests for Irritation and Skin Sensitization. ANSI AAMI ISO 10993-5:2009/(R)2014 Biological Evaluation of Medical Devices - Part 5, Tests for In Vitro Cytotoxicity. ANSI AAMI ISO 10993-11:2017 Biological Evaluation of Medical Devices - Part 11, Tests for Systemic Toxicity. {10}------------------------------------------------ ## 510(K) SUMMARY AS REQUIRED BY: 21CFR§807.92 ### H. SUMMARY OF CLINICAL PERFORMANCE TESTING Not applicable - Clinical data is not needed for gloves. ### I. CONCLUSION The conclusion drawn from the nonclinical tests demonstrates that the subject device in 510(k) submission, First Glove Blue Nitrile Examination Gloves Powder free is as effective, and performs as well as or better than the legally marketed predicate device K202384.