Edma Synthetic Nitrile Examination Gloves

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & 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. August 9, 2021 Edma Group, LLC % Boyle Wang Official Correspondent Shanghai Truthful Information Technology Co., Ltd. RM. 1801, No. 161, Lujiazui East Rd., Pudong Shanghai, 200120 China Re: K211540 Trade/Device Name: Edma Synthetic Nitrile Examination Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Non-powdered patient examination glove Regulatory Class: Class I, reserved Product Code: LZA Dated: May 12, 2021 Received: May 19, 2021 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 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. 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) K211540 Device Name Edma Synthetic Nitrile Examination Gloves Indications for Use (Describe) A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands or finger 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 (K211540) This summary of 510(k) is being submitted in accordance with 21 CFR 807.92. ### 1.0 Submitter's Information Edma Group, LLC. Name: Address: 3634 E Piccadilly Rd, Phoenix, AZ 85018. Contact: Mr. Vio Cretu Date of Preparation: 07/03/2021 #### Designated Submission Correspondent Mr. Boyle Wanq 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: Edma Synthetic Nitrile Examination Gloves Common name: Patient Examination Glove Classification name: Non-powdered patient examination glove Model(s): M. L. XL #### 3.0 Classification Production code: LZA Regulation number: 21CFR880.6250 Classification: Class I Panel: General Hospital #### 4.0 Predicate Device Information Manufacturer: Careglove Global Sdn Bhd Device: Powder Free Nitrile Examination Gloves, Blue (colored) 510(k) number: K172015 #### 5.0 Indication for Use {4}------------------------------------------------ A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands or finger to prevent contamination between patient and examiner. # 6.0 Device Description The subject device is powder free synthetic Nitrile patient examination gloves. The subject device is blue. The design of subject device is addressing the standards as ASTM D6124, ASTM D5151, and ASTM D6319. The subject device is non-sterile. | Item | Subject device | Predicate device | Comparison | |-----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------| | 510(k) number | K211540 | K172015 | -- | | Product Code | LZA | LZA | Same | | Regulation No. | 21CFR880.6250 | 21CFR880.6250 | Same | | Class | I | I | Same | | Intended Use | A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands or finger to prevent contamination between patient and examiner. | A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hand or finger to prevent contamination between patient and examiner. | Same | | Powdered or<br>Powered free | Powdered free | Powdered free | Same | | Main Material | Nitrile | Nitrile | Same | | Colorant | Blue | Blue | Same | | Design Feature | Ambidextrous | Ambidextrous | Same | | Single Use | Yes | Yes | Same | | Sterility status | Non-Sterile | Non-Sterile | Same | | Dimensions(mm) | Length:≥230;<br>Width:<br>M:95±10;<br>L:110±10;<br>XL:120±10; | Length:<br>XS/S:≥220;<br>M/L/XL: ≥230;<br>Width:<br>XS:70±10;<br>S:80±10;<br>M:95±10;<br>L:110±10;<br>XL:120±10; | Similar | | Physical | Before Tensile 14MPa min | Tensile 14MPa min | Same | # 7.0 Technological Characteristic Comparison Table {5}------------------------------------------------ | Properties | Aging | Strength | | Strength | | | | |--------------------------|----------------|-------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|------|------| | | | Ultimate<br>Elongation | 500%min | Ultimate<br>Elongation | 500%min | Same | | | | After<br>Aging | Tensile<br>Strength | 14MPa,min | Tensile<br>Strength | 14MPa,min | Same | | | | | Ultimate<br>Elongation | 400%min | Ultimate<br>Elongation | 400%min | Same | | | Freedom<br>from<br>Holes | | Be free from holes when<br>tested in accordance<br>with ASTM | | Meet AQL 1.5<br>Meet AQL 2.5 | | Same | | | | | AQL=2.5 | D5151 | | | | | | Powder Content | | <0.07 mg per glove.<br>Meet the requirements<br>of ASTM D6124 | | | Meet 2mg/glove max.<br>Meet the requirements<br>of ASTM D6124 | | Same | | Biocompatibility | | Irritation: Under the<br>conditions of the study,<br>not an irritant or a<br>sensitizer. | | Under the conditions of<br>this study the test<br>material did not cause an<br>irritant response. | | | | | | | Sensitization: Under<br>conditions of the study,<br>not a sensitizer. | | Under the conditions of<br>this study,the test<br>material did not produce<br>a skin sensitization effect | | Same | | | | | Cytotoxicity: Under<br>conditions of the study,<br>did not show potential<br>toxicity to L-929 cells. | | / | | | | | | | | | | | | | | Labeling<br>Information | | | Single use, powder free,<br>device color, device<br>name, glove size and<br>quantity, Non-Sterile | | Single use, powder free,<br>device color, device<br>name, glove size and<br>quantity, Non-Sterile | Same | | # 8.0 Summary of Non-clinical Testing Non clinical tests were conducted to verify that the subject device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The subject device were evaluated according to the following standards: ASTM D6319-19, Standard Specification for Nitrile Examination Gloves for Medical Application. ASTM D6124-06 (Reapproved 2017), Standard Test Method for Residual Powder on Medical Gloves {6}------------------------------------------------ ASTMD5151-19, Standard Test Method for Detection of Holes in Medical Gloves. # Biocompatibility Testing: The biocompatibility evaluation for the subject device were evaluated according to the following standard: ISO 10993-5:2009 Biological Evaluation Of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity. ISO 10993-10:2010 Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization. Biocompatibility testing including cytotoxicity test, sensitization test and irritation test according to ISO 10993-1 standards, have been conducted on the Edma Synthetic Nitrile Examination Gloves. Under the parameters of the tests it is concluded that they are biocompatible, and that there are no new issues of biocompatibility regarding their use as intended. | Test<br>Methodology | Purpose | Acceptance Criteria | Results | |---------------------|-----------------------------------------------------|-------------------------------------------------------------------------|-------------------------------------------------------------------------| | ASTM D6319 | Physical<br>Dimensions<br>Test | Length(mm):≥230;<br>Width(mm):<br>M: 95±10;<br>L: 110±10;<br>XL: 120±10 | Length: >230<br>Width:<br>M: 96-99<br>L: 106-109<br>XL: 114-118<br>Pass | | | | Thickness (mm):<br>Finger: ≥0.08<br>Palm: ≥0.08 | Finger: 0.08-0.13<br>Palm: 0.08-0.09<br>Pass | | ASTM D5151 | Watertightness<br>Test for<br>Detection of<br>Holes | Meet the requirements of ASTM D5151 AQL 2.5 | 0/125 leaks<br>Pass | | ASTM D6124 | Powder Content | Meet the requirements of ASTM D6124 < 2.0mg | 0.07 mg<br>Pass | | ASTM D412 | Physical<br>properties | Before Tensile<br>Aging Strength ≥14MPa | 15-18.5<br>Pass | ### Table 2: Performance Characteristic Comparison {7}------------------------------------------------ | | | | Ultimate<br>Elongation | ≥500% | 506-576<br>Pass | | |--------------|---------------|-----------------|------------------------|--------|-----------------|----------------------------------------------------------------------------------------------------| | | | After<br>Aging | Tensile<br>Strength | ≥14MPa | 14-17.6<br>Pass | | | | | | Ultimate<br>Elongation | ≥400% | 400-522<br>Pass | | | ISO 10993-5 | Cytotoxicity | Non-cytotoxic | | | | Under conditions<br>of the study, did<br>not show potential<br>toxicity to L-929<br>cells.<br>Pass | | ISO 10993-10 | Irritation | Non-irritating | | | | Under the<br>conditions of the<br>study, not an<br>irritant.<br>Pass | | ISO 10993-10 | Sensitization | Non-sensitizing | | | | Under conditions<br>of the study, not a<br>sensitizer.<br>Pass | # 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 proposed device, K211540 is as safe, as effective, and performs as well as or better than the legally marketed predicated device.