Blue Nitrile Examination Gloves Powder Free

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May 28, 2022 Amazing Rubber Products Pvt Ltd % Manoj Zacharias Consultant Liberty Management Group Ltd. 75 Executive Dr. STE114 Aurora, Illinois 60504 Re: K212584 Trade/Device Name: 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: April 28, 2022 Received: May 2, 2022 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. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal {1}------------------------------------------------ Page 2 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, Clarence W. Murray, III, PhD Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K212584 Device Name Blue Nitrile Examination Gloves Powder Free #### Indications for Use (Describe) Blue Nitrile Examination Gloves Powder Free is disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. | Type of Use (Select one or both, as applicable) | |-------------------------------------------------| |-------------------------------------------------| | Serve The Community (21 CFR 601 Subpart C) | <span style="text-decoration: overline;">X</span> | |----------------------------------------------|---------------------------------------------------| | Registration Use (Part 21 CFR 601 Subpart B) | | __ 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 K212584 As required by: 21CFR§807.92(c) ## A. APPLICANTINFORMATION | 510(K) Owner's Name | Amazing Rubber Products Pvt. Ltd. | |---------------------|---------------------------------------------------------------------------------------| | Address | Plot No 14c, Cochin Special Economic Zone, Kakkanad,<br>Cochin-682 037, Kerala- India | | Phone | 9447053062 | | Fax | ----- | | E-mail | info@amazingglove.com | | Contact Person | Mr. Jayasankar S | | Designation | Executive Director | | Contact Number | 9447053062 | | Contact Email | info@amazingglove.com | | Date Submitted | 12 August 2021 | #### B. DEVICE IDENTIFICATION | Name of the device | Blue Nitrile Examination Gloves Powder Free | |-----------------------------------|---------------------------------------------| | Product proprietary or trade name | Amazing+ | | Common or usual name | Exam Gloves | | Classification name | Patient Examination Gloves | | Device Classification | Class-1 | | Product Code | LZA | | Regulation Number | 21 CFR 880.6250 | | Review Panel | General Hospital | ## C. PREDICATE DEVICE | Predicate Device | JR Engineering & Medical Technologies (M) SDN.BHD | |------------------|---------------------------------------------------| | 510( K) Number | K192333 | | Regulatory Class | I | | Product code | LZA | ## D. DESCRIPTION OF THEDEVICE: Blue Nitrile Examination Gloves Powder Free are Class I patient examination gloves bearing the product code Nitrile - LZA (21CFR880.6250). The gloves are made from acrylonitrilebutadiene copolymer dispersion. These gloves are blue in color and are powder free. ## E. INTENDED USE OF THE DEVICE: Blue Nitrile Examination Gloves Powder Free is disposable devices intended for medical purpose that are worn on the examiner's hand to prevent contamination between patient and examiner. {4}------------------------------------------------ ## F. SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED TO THE PREDICATEDEVICE | Characteristics | Standards | Device Performance | | Comparison | |-----------------------|----------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------| | | | Predicate | Subject | | | 510(K) Number | | K192333 | K212584 | ---- | | Name of device | | JR MEDIC Blue Nitrile<br>Examination Gloves<br>Powder-free | Blue Nitrile<br>Examination Gloves<br>Powder Free | ---- | | Dimensions | ASTM D6319-<br>2019 | Length Min 230 m Width<br>Min 95+/-10<br>mm(for medium size) | Length Min 230 mm<br>Width Min 95+/-10<br>mm(for medium size) | Same | | Physical Properties | ASTM D6319-2019 | <b>Before Aging</b><br>Tensile Strength<br>min 14 Mpa<br>Ultimate Elongation<br>Min 500%<br><b>After Aging</b><br>Tensile Strength<br>min 14 Mpa<br>Ultimate Elongation<br>Min 400% | <b>Before Aging</b><br>Tensile Strength min<br>14 Mpa<br>Ultimate Elongation<br>Min 500%<br><b>After Aging</b><br>Tensile Strength<br>min 14 Mpa<br>Ultimate Elongation<br>Min 400% | Same | | Thickness | ASTM D6319-2019 | Palm min 0.05 mm<br>Finger min 0.05 mm | Palm min 0.05 mm<br>Finger min 0.05 mm | Same | | Powder Residue | ASTM D6319-2019 | $\le$ 2 mg/glove | $\le$ 2 mg/glove | Similar | | Biocompatibility | Primary Skin<br>Irritation-<br>ISO 10993-<br>10:2010(E) | Under the condition of<br>study not an irritant | Under the condition<br>of study not an<br>irritant | Same | | | Dermal<br>Sensitization- ISO<br>10993-10:2010(E) | Under the conditions of<br>the study not a sensitizer | Under the conditions<br>of the study not a<br>sensitizer | Same | | | In vitro cytotoxicity<br>ISO10993-5<br>:2009(E) | Under the conditions of<br>the study, cytotoxic | Under the conditions<br>of the study cytotoxic | Same | | | Acute Systemic<br>Toxicity Test ISO<br>10993-11:2017(E) | Under the conditions<br>of study the device<br>extracts do not pose a<br>systemic toxicity concern | Under the conditions<br>of study the device<br>extracts do not pose a<br>systemic toxicity<br>concern | Same | | | Material Mediated<br>Pyrogenicity ISO<br>10993-11:2017(E) /<br>USP 41<151> | Under the conditions of<br>the study the device<br>extract did not show a<br>material mediated<br>pyrogenicity response. | Under the conditions<br>of the study the<br>device extract did<br>not show a material<br>mediated<br>pyrogenicity<br>response. | Same | | Characteristics | Standards | Device Performance | | Comparison | | | | Predicate | Current | | | Water Tight (1000 ml) | ASTM D5151-<br>2019 | Passes AQL-1.5 | Passes AQL-1.5 | Similar | | Intended use | | JR MEDIC Blue Nitrile<br>Examination Gloves<br>Powder-free is disposable<br>devices intended for medical<br>purpose that are won on<br>the examiner's hand to prevent<br>contamination between patient<br>and examiner. | Blue Nitrile<br>Examination Gloves<br>Powder free is<br>disposable devices<br>intended for medical<br>purpose that are worn<br>on the examiner's hand<br>to prevent<br>contamination between patient and<br>examiner. | Similar | | Material | ASTM<br>D6319-<br>2019 | Nitrile | Nitrile | Same | | Color | - | Blue | Blue | Same | | Texture | - | Finger Texture | Finger texture | Same | | Size | ASTM<br>D6319-<br>2019 | Extra Small, Small,<br>Medium, Large, Extra<br>Large | Extra Small, Small,<br>Medium, Large, Extra<br>Large | Same | | Single Use | Medical Glove<br>Guidance<br>Manual<br>- Labeling | Single Use | Single Use | Same | | Manufacturer(s) | - | JR Engineering &<br>Medical<br>Technologies<br>(M) SDN.BHD.<br>Malaysia | Amazing Rubber<br>Products Pvt. Ltd. | ------ | {5}------------------------------------------------ ## NON-CLINICAL TESTING SUMMARY #### PERFORMANCE DATA Result Test Method Acceptance Criteria Purpose ASTM D6319-2019 Standard To determine the Min 230 mm for all sizes X-Small:- 303 mm Specification for Nitrile length of the gloves Small:-304 mm Examination Gloves Medium:-305mm for Medical Application Large:-306mm X-Large:- 307mm ASTM D6319-2019 Standard To determine the X-small:-70+/-10 mm X-small-74 mm Specification for Nitrile width of the gloves Small:-80+/-10 mm Small:-84 mm Examination Gloves for Medium:- 95+/-10mm Medium:- 94 mm Medical Application Large:-110+/-10 mm Large:-104 mm X-Large:- 120+/-10 mm X-Large:- 115 mm {6}------------------------------------------------ | Test Method | Purpose | Acceptance<br>Criteria | Result | | | |--------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------|------------------------------------------------------------------------------|-----------------------------------------------------------------------------| | ASTM D6319-2019 Standard<br>Specification for Nitrile<br>Examination Gloves for<br>Medical Application | To determine the<br>thickness of the<br>gloves | Palm 0.05 mm min<br>Finger 0.05 mm min<br>for all sizes | Size<br>X-Small<br>Small<br>Medium<br>Large<br>X-Large | Palm<br>0.10mm<br>0.10mm<br>0.10mm<br>0.10mm<br>0.10mm | Finger<br>0.12mm<br>0.12mm<br>0.12mm<br>0.12mm<br>0.12mm | | ASTM D6319-2019 Standard<br>Specification for Nitrile<br>Examination Gloves for<br>Medical Application | To Determine the<br>physical properties-<br>Tensile strength | Before Ageing<br>Tensile Strength<br>14Mpa Min for all<br>sizes<br>After Ageing<br>Tensile Strength<br>14Mpa Min for all<br>sizes | Size<br>X-Small<br>Small<br>Medium<br>Large<br>X-Large | Before<br>ageing<br>18.44Mpa<br>18.49Mpa<br>18.56Mpa<br>18.62Mpa<br>18.64Mpa | After<br>ageing<br>17.49Mpa<br>17.53Mpa<br>17.65Mpa<br>17.71Mpa<br>17.76Mpa | | ASTM D6319-2019 Standard<br>Specification for Nitrile<br>Examination Gloves for<br>Medical Application | To Determine the<br>physical properties-<br>Ultimate Elongation | Before Ageing<br>Ultimate Elongation<br>500% Min for all<br>sizes<br>After Ageing<br>Ultimate<br>Elongation 400%<br>Min for all sizes | Size<br>X-Small<br>Small<br>Medium<br>Large<br>X-Large | Before<br>ageing<br>683%<br>687%<br>692%<br>695%<br>698% | After<br>ageing<br>656%<br>660%<br>663%<br>666%<br>669% | | Test Method | Purpose | Acceptance<br>Criteria | Result | |-----------------------------------------------------------------------------------------------------|------------------------------------------------------|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | ASTM D5151-2019 Standard<br>Test Method for Detection of<br>Holes in Medical Gloves | To determine the<br>holes in the gloves | AQL 1.5 | Gloves Passes AQL 1.5 | | ASTM D6124-06 (Reapproved<br>2017) Standard Test Method<br>for Residual Powder on<br>Medical Gloves | To determine the<br>residual powder in<br>the gloves | 2 Mg/Glove Max | Size<br>X-small<br>Small<br>Medium<br>Large<br>X-Large<br><br>Residual Powder<br>Content<br>0.21mg/glove<br>0.21mg/glove<br>0.22 mg/glove<br>0.22 mg/glove<br>0.22 mg/glove | {7}------------------------------------------------ #### BIO-COMPATIBILITY DATA | Test Method | Purpose | Acceptance<br>Criteria | Result | |---------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------| | ISO 10993-10 Biological<br>Evaluation of Medical Devices<br>Test for Irritation and Skin<br>Sensitization. Test done for<br>irritation. | To determine the potential of<br>the material under test to<br>produce dermal irritation in<br>Rabbits | Under the condition<br>of study not an<br>irritant | Under the condition of<br>study not an irritant | | ISO 10993-10 Biological<br>Evaluation of Medical Devices<br>Test for Irritation and Skin<br>Sensitization. Test done Skin<br>sensitization. | To determine the skin<br>sensitization potential of the<br>material both in terms of<br>induction and elicitation in<br>Guinea Pig. | Under the<br>conditions of the<br>study not a<br>sensitizer | Under the conditions of<br>the study not a<br>sensitizer | | ISO 10993-5:2009 biological<br>evaluation of medical devices -<br>part 5, tests for in vitro<br>cytotoxicity. | To evaluate the in vitro<br>cytotoxic potential of the test<br>item (both inner and outer<br>surface) Extracts in L-929<br>mouse fibroblasts cells using<br>elution method. | Under the<br>conditions of study<br>non cytotoxic | Under the conditions of<br>the study cytotoxic. | | ISO 10993-11:2017 biological<br>evaluation of medical devices -<br>part 11, tests for systemic<br>toxicity. | To determine the acute<br>systemic toxicity potential of<br>the test item extracts (both<br>inside and outer surfaces) in<br>Swiss Albino mice. | Under the<br>conditions of study<br>the device extracts<br>do not pose a<br>systemic toxicity<br>concern | Under the conditions<br>of study the device<br>extracts do not pose a<br>systemic toxicity<br>concern | | Material Mediated<br>Pyrogenicity ISO 10993-<br>11:2017(E) / USP 41<151> | To determine the pyrogenic<br>potential of the test item<br>extract following intravenous<br>injection in New Zealand<br>white Rabbits. | Under the<br>conditions of the<br>study, the device<br>did not<br>demonstrate a<br>material mediated<br>pyrogenicity<br>response. | Under the conditions of<br>the study, the device did<br>not demonstrate a<br>material mediated<br>pyrogenicity response. | | | | | | ## G. Clinical Testing Summary Not applicable - Clinical data is not needed for gloves or for most devices cleared by the 510(K) process. # H. CONCLUSION The conclusions drawn from the nonclinical test demonstrate that the subject device in 510(K) submission, Blue Nitrile Examination Gloves Powder Free is as effective, and performs as well as or better than the legally marketed predicate device K192333.