Disposable Nitrile Powder-Free Examination Gloves (Tested for Use with Chemotherapy Drugs)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a smaller font. June 1, 2022 Anhui Zhong Lian Latex Gloves Manufacturing Co., Ltd. % Boyle Wang General Manager Shanghai Truthful Information Technology Co., Ltd. Room608,No.738,Shangcheng Rd.,Pudong Shanghai, Shanghai 200120 China Re: K220488 Trade/Device Name: Disposable Nitrile Powder-Free Examination Gloves (Tested for Use with Chemotherapy Drugs) Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I. reserved Product Code: LZA, LZC Dated: April 25, 2022 Received: May 2, 2022 Dear Boyle Wang: 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 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, Bifeng Oian, M.D., Ph.D. Acting 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) K220488 #### Device Name Disposable Nitrile Powder-Free Examination Gloves (Tested for Use with Chemotherapy Drugs) #### Indications for Use (Describe) A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical gloves to Permeation by Chemotherapy Drugs. | Chemotherapy Drug | Concentration | Breakthrough Detection Time in Minutes | |----------------------------|------------------------|----------------------------------------| | Carmustine (BCNU) | 3.3 mg/ml (3,300 ppm) | 23.6 (23.6, 27.5, 25.2) Minutes | | Cisplatin | 1.0 mg/ml(1,000 ppm) | > 240 Minutes | | Cyclophosphamide (Cytoxan) | 20.0 mg/ml(20,000 ppm) | > 240 Minutes | | Dacarbazine | 10 mg/ml (10,000 ppm) | > 240 Minutes | | Doxorubicin HCl | 2.0 mg/ml(2,000 ppm) | > 240 Minutes | | Etoposide | 20.0 mg/ml(20,000 ppm) | > 240 Minutes | | Fluorouracil | 50.0 mg/ml(50,000 ppm) | >240 Minutes | | Methotrexate | 25 mg/ml (25,000 ppm) | >240 Minutes | | Mitomycin C | 0.5 mg/ml (500 ppm) | >240 Minutes | | Paclitaxel | 6.0 mg/ml(6,000 ppm) | >240 Minutes | | Thio Tepa | 10.0 mg/ml(10,000 ppm) | 37.4 (38.8, 37.4, 37.5) Minutes | | Vincristine Sulfate | 1 mg/ml (1,000 ppm) | > 240 Minutes | Please note that the following drugs have low permeation times: Carmustine (BCNU) 3.3 mg/ml 23.6 Minutes (min.); Thio Tepa 10.0 mg/ml 37.4 Minutes (min.). Warning: Please do not use with Carmustine (BCNU) and Thiotena. | 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 # K220488 This summary of 510(k) K220488 is being submitted in accordance with 21 CFR 807.92. #### 1.0 Submitter's Information Name: ANHUI ZHONG LIAN LATEX GLOVES MANUFACTURING CO., LTD. Address: GUZHEN ECONOMIC DEVELOPMENT ZONE BENGBU CITY ANHUI CHINA GUZHEN ECONOMIC DEVELOPMENT ZONE BENGBU CITY Contact: ANHUI CHINA Date of Preparation: 2022.05.26 #### Designated Submission Correspondent Mr. Boyle Wang Shanghai Truthful Information Technology Co., Ltd. Room 1801, No. 161 Lujiazui East Rd., Pudong Shanghai, 200120 China Tel: +86-21-50313932 Email: Info@truthful.com.cn #### 2.0 Device Information Trade name: Disposable Nitrile Powder-Free Examination Gloves (Tested for Use with Chemotherapy Drugs) Common name: Patient Examination Gloves Classification name: Non-powdered patient examination glove Model(s): S. M. L. XL ### 3.0 Classification Production code: LZA,LZC Requlation number: 21CFR880.6250 Classification: Class I Panel: General Hospital #### 4.0 Predicate Device Information Ever Growth (Vietnam) Co., Ltd. Manufacturer: Disposable Powder Free Nitrile Examination Glove, Tested For Device: {4}------------------------------------------------ Use With Chemotherapy Drugs, Disposable Powder Free Nitrile Examination Glove, Tested For Use With Chemotherapy Drugs, Orange Color 510(k) number: K190860 #### 5.0 Device Description The subject device is single use, disposable gloves intended for medical purposes to be worn on the examiner's hands to prevent contamination between patient and examiner. The gloves are powder-free, ambidextrous with beaded cuff, blue colored, nitrile, and tested for use with chemotherapy drugs. The gloves are offered in four sizes: small, medium, large, and extra-large. #### 6.0 Indication for Use A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical gloves to Permeation by Chemotherapy Drugs | Chemotherapy Drug | Concentration | Breakthrough Detection<br>Time in Minutes<br>(minutes) | |-------------------------------|------------------------|--------------------------------------------------------| | Carmustine (BCNU) | 3.3 mg/ml (3,300 ppm) | 23.6<br>(23.6, 27.5, 25.2 ) | | Cisplatin | 1.0 mg/ml(1,000 ppm) | > 240 | | Cyclophosphamide<br>(Cytoxan) | 20.0 mg/ml(20,000 ppm) | > 240 | | Dacarbazine | 10 mg/ml (10,000 ppm) | > 240 | | Doxorubicin HCI | 2.0 mg/ml(2,000 ppm) | > 240 | | Etoposide | 20.0 mg/ml(20,000 ppm) | > 240 | | Fluorouracil | 50.0 mg/ml(50,000 ppm) | > 240 | | Methotrexate | 25 mg/ml (25,000 ppm) | > 240 | | Mitomycin C | 0.5 mg/ml (500 ppm) | > 240 | | Paclitaxel | 6.0 mg/ml(6,000 ppm) | > 240 | | Thio Tepa | 10.0 mg/ml(10,000 ppm) | 37.4<br>(38.8, 37.4, 37.5) | | Vincristine Sulfate | 1 mg/ml (1,000 ppm) | > 240 | Please note that the following drugs have low permeation times: Carmustine (BCNU) 3.3 mg/ml 23.6 Minutes (min.); Thio Tepa 10.0 mg/ml 37.4 Minutes (min.). Warning: Please do not use with Carmustine (BCNU) and Thiotepa. {5}------------------------------------------------ # 7.0 Technological Characteristic Comparison Table | Item | Subject Device<br>K220488 | Predicate Device<br>(K190860) | Remark | |----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------| | Product Code | LZA,LZC | LZA,LZC | Same | | Regulation No. | 21CFR880.6250 | 21CFR880.6250 | Same | | Class | I | I | Same | | Intended<br>Use/Indications for<br>Use | A patient examination<br>gloves is a disposable<br>device intended for medical<br>purpose that is worn on the<br>examiner's hand or<br>fingers to prevent<br>contamination between<br>patient and examiner. In<br>addition, these gloves were<br>tested for use with<br>chemotherapy drugs in<br>accordance with ASTM<br>D6978-05 Standard<br>Practice for Assessment of<br>Medical gloves to<br>Permeation by<br>Chemotherapy Drugs. | A patient examination gloves<br>is a disposable device<br>intended for medical purpose<br>that is worn on the<br>examiner's hand or<br>fingers to prevent<br>contamination between<br>patient and examiner. In<br>addition, these gloves were<br>tested for use with<br>chemotherapy drugs in<br>accordance with ASTM<br>D6978-05 Standard Practice<br>for Assessment of Medical<br>gloves to<br>Permeation by<br>Chemotherapy Drugs. | Same | | Powdered or<br>Powered free | Powdered free | Powdered free | Same | | Design Feature | Ambidextrous | Ambidextrous | Same | | Sterility | Non-Sterile | Non-Sterile | Same | | Labeling Information | Single-use indication,<br>powder free, device color,<br>device name, glove size and<br>quantity,Non-Sterile,<br>a statement of standard<br>ASTM D6978-05<br>compliance and a<br>summary of the testing<br>results. | Single-use indication,<br>powder free, device color,<br>device name, glove size and<br>quantity, Non-Sterile, a<br>statement of standard<br>ASTM D6978-05<br>compliance and a summary<br>of the testing results. | Similar | #### Table1-General Comparison ### Table2 Device Dimensions Comparison | Predicate<br>Device(K190860) | Designation | Size | | | | | Tolerance | |------------------------------|-------------|------|---|---|---|----|-----------| | | | XS | S | M | L | XL | | {6}------------------------------------------------ | | Length, mm | 230 | 230 | 230 | 230 | 230 | min | |----------------|----------------|------|-----|-----|-----|-----------|-----| | | Width, mm | 70 | 80 | 95 | 110 | 120 | ±10 | | | Thickness, mm: | | | | | | | | | Finger | 0.05 | | | | | min | | | Palm | 0.05 | | | | | min | | Subject Device | Designation | Size | | | | Tolerance | | | | | S | M | L | XL | | | | | Length, mm | 220 | 230 | 230 | 230 | min | | | | Width, mm | 80 | 95 | 110 | 120 | ±10 | | | | Thickness, mm: | | | | | | | | | Finger | 0.05 | | | | | min | | | Palm | 0.05 | | | | | min | | Remark | Different | | | | | | | Analysis: The physical dimensions are different with that of the predicate, but they all meet the requirements of ASTM D6319-19,so the differences do not raise any new safety or performance questions. | Item | Subject device<br>K220488 | Predicate device<br>(K190860) | Remark | | | |-----------------------------------------------------------|----------------------------------------------------------|-----------------------------------------------------------------------------------|------------------------|---------------------------------------------------------------------------------------------------------|---------| | Colorant | Blue | White, Orange | Different 1 | | | | Physical<br>Properties | Before<br>Aging | Tensile<br>Strength | 14MPa, min | 14MPa, min | Same | | | | Ultimate<br>Elongation | 500% min | 500% min | Same | | | After<br>Aging | Tensile<br>Strength | 14MPa, min | 14MPa, min | Same | | | | Ultimate<br>Elongation | 400%min | 400%min | Same | | | Comply with ASTM D6319 | | Comply with ASTM D6319 | Same | | | Freedom from Holes | | Be free from holes when tested in accordance with ASTMD5151 AQL=2.5 | | Be free from holes when tested in accordance with ASTMD5151 AQL=2.5 | Same | | Powder Content | | 0.09-0.11 mg per glove, Meet the requirements of ASTM D6124 | | Meet the requirements of ASTM D6124 | Same | | Chemotherapy Drugs<br>Tested with Minimum<br>Breakthrough | | Carmustine (BCNU) 3.3 mg/ml:<br>23.6 Minutes (min.)<br>Cisplatin 1.0 mg/ml: > 240 | | Carmustine (BCNU) 3.3 mg/ml:<br>White:11.8 Minutes;<br>Orange:31.6Minutes<br>Cisplatin 1.0 mg/ml: > 240 | Similar | | Detection Time as<br>Tested per ASTM D<br>6978 | Minutes | 240 Minutes | | | | | | Cyclophosphamide (Cytoxan)<br>20.0 mg/ml: > 240 Minutes | Cyclophosphamide<br>(Cytoxan)<br>20.0 mg/ml: > 240<br>Minutes | Same | | | | | Dacarbazine 10 mg/ml:> 240<br>Minutes | Dacarbazine (DTIC)<br>10.0 mg/ml:<br>>240 Minutes | Same | | | | | Doxorubicin HCl 2.0 mg/ml: ><br>240 Minutes | Doxorubicin<br>Hydrochloride 2.0<br>mg/ml: >240 Minutes | Similar | | | | | Etoposide 20.0 mg/ml: > 240<br>Minutes | Etoposide (Toposar)<br>20.0<br>mg/ml: >240 Minutes | Similar | | | | | Fluorouracil 50.0 mg/ml: ><br>240 Minutes | Fluorouracil 50.0<br>mg/ml: >240<br>Minutes | Same | | | | | Methotrexate, 25 mg/ml<br>(25,000 ppm): >240 Minutes | / | | | | | | Mitomycin C, 0.5 mg/ml (500<br>ppm): >240 Minutes | / | Different 2 | | | | | Paclitaxel 6.0 mg/ml: >240<br>Minutes | Paclitaxel (Taxol) 6.0<br>mg/ml:<br>>240 Minutes | Same | | | | | Thio Tepa 10.0 mg/ml: 37.4<br>Minutes (min.) | Thio-Tepa 10.0 mg/ml:<br>White:16.9 Minutes;<br>Orange: 72.5 Minutes | Similar | | | | | Vincristine Sulfate, 1mg/ml<br>(1,000 ppm): >240 Minutes | / | Different 2 | | | # Table3 Performance Comparison {7}------------------------------------------------ Analysis: Different 1: The color of the subject device is different of that of the predicate. Biocompatibility testing was successfully completed for the subject device, demonstrating that any color differences do not affect the safety of the proposed device. Different 2: The chemotherapy drug is different with that of the predicate, but they all meet the requirements of ASTM D6978-05(2019),so the differences do not raise any new safety or performance questions. ### Table4 Safety Comparison {8}------------------------------------------------ | Item | | Proposed device | Predicated device | Remark | |--------------------|-------------------|-----------------------------------------------------------------------------------------------------------------|--------------------------------------------------|-----------| | Material | | Nitrile | Nitrile | SAME | | Biocompatibility | Irritation | Under the conditions of the study, not an irritant | Comply with ISO10993-10 | SAME | | | Sensitization | Under conditions of the study, not a sensitizer. | | | | | Cytotoxicity | Under the conditions of the study, the device is potentially cytotoxic | Comply with ISO10993-5 | Analysis3 | | | Systemic toxicity | Under the conditions of the study, the device does not elicit a systemic toxicity response in the model animal. | Complies with ISO 10993-11 Third edition 2017-09 | | | Label and Labeling | | Meet FDA's Requirement | Meet FDA's Requirement | SAME | Analysis3: The proposed device is potentially cytotoxic, but all proposed devices are conducted the systemic toxicity test, the test results show that the proposed device is safe. #### 8.0 Summary of Non-Clinical Testing #### Biocompatibility Testing biocompatibility evaluation for Disposable Nitrile The Powder-Free Examination Gloves (Tested for Use with Chemotherapy Drugs) was conducted in accordance with the following standards: ISO 10993-10:2010 Biological Evaluation of Medical Devices - Part 10: Tests for Irritation And Skin Sensitization. ISO 10993-5:2009 Biological Evaluation of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity ISO 10993-11 Third edition 2017-09 Biological evaluation of medical devices -Part 11: Tests for systemic toxicity #### Performance Testing (Bench) Physical performance qualities of the proposed device were evaluated per ASTM D6319-10, Standard Specification for Disposable Nitrile Powder-Free Examination Gloves for Medical Application. Permeation testing was conducted to support the addition of the labeling claim: Tested for use with chemotherapy drugs. In addition, the proposed device was tested according to ASTM D6978-05 (Reapproved 2019), Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs, in which minimum breakthrough times were determined for a wide range of chemotherapy drugs. {9}------------------------------------------------ In summary, the performance testing of the subject device was conducted to adequately demonstrate the effectiveness of the device in accordance with the relevant test methods cited below: - ASTM D6124-06 (Reapproved 2017), Standard Test Method for -Residual Powder on Medical Gloves - ASTM D5151-19, Standard Test Method for Detection of Holes in -Medical Gloves. - ASTM D6319-19, Standard Specification for Disposable Nitrile -Powder-Free Examination Gloves for Medical Application. - -ASTM D 6978-05 (Reapproved 2019) ,Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs. - | No. | Name of the Test<br>Methodology / Standard | Purpose | Acceptance Criteria | Results | |-----|--------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------| | 1 | ISO 10993-10:2010<br>Biological Evaluation Of<br>Medical Devices - Part<br>10: Tests For Irritation<br>And Skin Sensitization. | This part of ISO<br>10993 assesses<br>possible contact<br>hazards from<br>chemicals<br>released from<br>medical devices,<br>which may<br>produce skin and<br>mucosal irritation,<br>eye irritation or<br>skin sensitization. | Skin Sensitization Test:<br>provided<br>grades less than 1,<br>otherwise<br>sensitization. | All grades are 0.<br><br>All animals were survived and no<br>abnormal signs were observed<br>during the study. | | 2 | | | Skin Irritation Test:<br>If the primary irritation<br>index is 0-0,4, the<br>response category is<br>Negligible.<br>0,5-1,9 means slight<br>2-4,9 means moderate<br>5-8 means severe | The primary irritation index is 0.<br><br>The response of the proposed<br>device was categorized as<br>negligible under the test<br>condition | | 3 | ISO 10993-5:2009<br>Biological Evaluation Of<br>Medical Devices - Part<br>5: Tests For In Vitro<br>Cytotoxicity | This part of ISO<br>10993 describes<br>test methods to<br>assess the in vitro<br>cytotoxicity of<br>medical devices. | The viab.% of the<br>100% extract of the<br>test article is the final<br>result, and if viability is<br>reduced to <70% of<br>the blank, it has<br>cytotoxic potential. | Viab.% of 100% test article<br>extract is 21.0%<br><br>It means the proposed device<br>have potential toxicity to L-929 in<br>the MTT method | | 7 of | 7 | |------|---| |------|---| {10}------------------------------------------------ | 4 | ISO 10993-11: 2017<br>Biological evaluation of<br>medical devices — Part<br>11: Tests for systemic<br>toxicity | To evaluate the<br>potential for<br>medical device<br>materials to cause<br>adverse systemic<br>reactions. | Within the monitoring<br>period (72 h), if the<br>toxicosis response of<br>testing group is not<br>greater than that of<br>control group, the<br>testing sample is<br>regarded as<br>acceptable. | There was no evidence of<br>systemic toxicity from the extract. | | Tensile strength ≥ 14MPa<br>Ultimate Elongation ≥ 500%<br>After Accelerated Aging<br>Tensile strength ≥ 14MPa<br>Ultimate Elongation ≥ 400%<br>Powder-free Residue:<br>pl. Refer to No. 4 in table 5 | Tensile strength 15.2-17.6 MPa<br>Ultimate Elongation 629.928% - 788.321%<br>After Accelerated Aging<br>Tensile strength 14.2-18.7MPa<br>Ultimate Elongation 601.793% - 738.384%<br>Powder-free Residue:<br>pl. Refer to No. 4 in table 5<br>Lot no.:210518<br>Dimensions:<br>S: width: 83-85 mm<br>Length 252-255 mm<br>M: width 91-96 mm<br>Length 250-256 mm<br>L: width 101-106 mm<br>Length 254-261 mm<br>XL: width 111-116 mm<br>Length 254-258 mm<br>Thickness:<br>Finger 0.11mm<br>Palm 0.08mm<br>Physical properties:<br>Before aging<br>Tensile strength 17.1-24.4 MPa<br>Ultimate Elongation 525.655% - 750.940%<br>After Accelerated Aging<br>Tensile strength 14.0-18.1MPa<br>Ultimate Elongation 578.552% - 755.773%<br>Powder-free Residue:<br>pl. Refer to No. 4 in table 5<br>Lot no.:210520<br>Dimensions:<br>S: width: 82-86 mm<br>Length 246-250 mm | |---|------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 5 | ASTM D6124-06<br>(Reapproved 2017),<br>Standard Test Method<br>for Residual Powder on<br>Medical Gloves | This standard is<br>designed to<br>determine the<br>amount ofresidual<br>powder (or<br>filter-retained<br>mass) found<br>on medical gloves | powder residue limit of<br>2.0 mg | 0.09-0.11 mg /glove | | | | | 6 | ASTM<br>D5151-06(Reapproved2<br>015), Standard Test<br>Method for Detection of<br>Holes in Medical Gloves. | This test method<br>covers the<br>detection of holes<br>in<br>medical gloves. | Samples number: 125<br>gloves<br>AQL: 2.5 (ISO 2859)<br>Criterion ≤7 gloves<br>for water leakage | no glove water leakage found | | | | | 7 | ASTM<br>D6319-10(Reapproved<br>2015),Standard<br>Specification For Nitrile<br>Examination Gloves For<br>Medical Application. | This specification<br>covers certain<br>requirements for<br>nitrile rubber<br>gloves used in<br>conducting<br>medical<br>examinations and<br>diagnostic and<br>therapeutic<br>procedures. | Sterility: no need<br>Freedom from holes:<br>pl. Refer to No. 5 in<br>table 5<br>Dimensions:<br>S: width 80±10mm<br>Length ≥220 mm<br>M: width 95±10mm<br>Length ≥230 mm<br>L: width 110±10mm<br>Length ≥230 mm<br>XL: width 120±10mm<br>Length ≥230 mm<br>Thickness:<br>Finger ≥0.05 mm<br>Palm ≥0.05 mm<br><br>Physical properties: | N.A.<br>Please refer to No. 5 in table 5<br>Lot no.:210515<br>Dimensions:<br>S: width: 82-85 mm<br>Length 245-254 mm<br>M: width 91-94 mm<br>Length 249-255 mm<br>L: width 102-105 mm<br>Length 252-260 mm<br>XL: width 112-115 mm<br>Length 250-262 mm<br>Thickness:<br>Finger 0.11-0.12 mm<br>Palm 0.08 mm<br><br>Physical properties: | | | | {11}------------------------------------------------ {12}------------------------------------------------ | | | | | Length 245-249 mm<br>L: width 103-107 mm<br>Length 252-259 mm<br>XL: width 112-116 mm<br>Length 254-258 mm<br>Thickness:<br>Finger 0.11-0.12 mm<br>Palm 0.07-0.08 mm | |---|----------------|-----------------------------------------------------------------------------------|--|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | | | | Physical properties:<br>Before aging<br>Tensile strength 16.1-19.8 MPa<br>Ultimate Elongation 668.374% -<br>798.544%<br>After Accelerated Aging<br>Tensile strength 14.5-18.4MPa<br>Ultimate Elongation 621.273% -<br>745.388%<br>Powder-free Residue:<br>pl. Refer to No. 4 in table 5 | | 8 | ASTM D<br>6978 | Chemotherapy<br>Drugs<br>Tested with<br>Minimum<br>Breakthrough<br>Detection Time | | Carmustine (BCNU) 3.3 mg/ml: 23.6 Minutes (min.) | | | | | | Cisplatin 1.0 mg/ml: > 240 Minutes | | | | | | Cyclophosphamide (Cytoxan) 20.0 mg/ml: > 240<br>Minutes | | | | | | Dacarbazine 10 mg/ml :> 240 Minutes | | | | | | Doxorubicin HCl 2.0 mg/ml: > 240 Minutes | | | | | | Etoposide 20.0 mg/ml: > 240 Minutes | {13}------------------------------------------------ | | | Fluorouracil 50.0 mg/ml: >240 Minutes | |--|--|-------------------------------------------------------| | | | Methotrexate, 25 mg/ml (25,000 ppm): >240 Minutes | | | | Mitomycin C, 0.5 mg/ml (500 ppm): >240 Minutes | | | | Paclitaxel 6.0 mg/ml: >240 Minutes | | | | Thio Tepa 10.0 mg/ml: 37.4 Minutes (min.) | | | | Vincristine Sulfate, 1mg/ml (1,000 ppm): >240 Minutes | ## 9.0 _Summary of Clinical Testing Clinical testing is not needed for this device. #### 10.0 Conclusion The conclusions drawn from the nonclinical tests demonstrate that the subject device, Disposable Nitrile Powder-Free Examination Gloves (Tested for Use with Chemotherapy Drugs) is as safe, as effective, and performs as well as or better than the legally marketed predicated device under K190860.