Glovmaster Nitrile Examination Glove 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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. December 22, 2021 Glovmaster SDN. BHD. % Manoj Zacharias US Agent Liberty Management Group Limited 75 Executive Drive Suite 114 Aurora, Illinois 60504 Re: K212914 Trade/Device Name: Glovmaster Nitrile Examination Glove Powder Free Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA Dated: November 17, 2021 Received: November 29, 2021 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}------------------------------------------------ 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, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K212914 Device Name GLOVMASTER Nitrile Examination Glove Powder Free ### Indications for Use (Describe) GLOVMASTER Nitrile Examination Glove 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) | <input type="checkbox"/> Remediation Use (Ref 21 CFR 201.Subject D) | |------------------------------------------------------------------------------------| | <input checked="" type="checkbox"/> Own-Use/Third-Party Use (21 CFR 201.Subject G) | __ 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}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the logo for Glovmaster. The logo consists of a globe with a hand reaching out to it on the left, followed by the word "GLOVMASTER" in large, bold letters. Below the word "GLOVMASTER" are the words "Life, Safe, Health" in a smaller font. ### GLOVMASTER SDN. BHD (1390380-A) Head Quarters: BV05F20, IOI Boulevard, Jalan Kenari 5, Bandar Puchong Jaya, 47100 Puchong Selangor Tel : 603-86034781 Manufacturing: 154, Jalan 4, Kawasan Perindustrian Olak Lempit, 42700 Banting, Selangor. # 510(k) SUMMARY (K212914) [AS REQUIRED BY 21CFR807.92] #### I. SUBMITTER | 510(k) Owner's Name | : | Glovmaster SDN. BHD. | |--------------------------|---|----------------------------------------------------------------------------------------| | Address | : | 154, Jalan 4, Kawasan Perindustrian Olak Lempit, 42700<br>Banting, Selangor, Malaysia. | | Telephone | : | +603-86034781 | | Contact person | : | Ms. Zarina binti Hamid | | Designation | : | QMS Manager | | Contact Number | : | +6013-5928225 | | Contact Email | : | ina@glovmaster.com.my | | Date of Summary Prepared | : | 21.12.2021 | - II. DEVICE | Device Name | : | GLOVMASTER Nitrile Examination Glove Powder Free | |----------------------------|---|--------------------------------------------------| | Device Common Name | : | Nitrile Examination Glove Powder Free | | Device Classification name | : | Non-powdered patient examination glove | | Regulation Number | : | 21 CFR 880.6250 | | Class | : | I | | Product Code | : | LZA | ## III. PREDICATE DEVICE | Predicate Device Name | : | JR Medic Blue Nitrile Examination Gloves Powder Free | |-----------------------|---|------------------------------------------------------| | 510(k) Number | : | K192333 | | Regulation Number | : | 21 CFR 880.6250 | | Class | : | I | | Product Code | : | LZA | {4}------------------------------------------------ ## IV. DEVICE DESCRIPTION GLOVMASTER Nitrile Examination Glove Powder Free is a Class I device bearing the product code LZA (21CFR 880.6250). 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 acrylonitrilebutadiene copolymer dispersion. These gloves are blue in color having Finger Texture, Ambidextrous and are powder free. The product is non-sterile. ### INDICATIONS FOR USE V. GLOVMASTER Nitrile Examination Glove 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 # VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE | SI.<br>No | Features compared | Proposed Device | Predicate Device | Comparison | | | | | | |-----------|---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|--|--|--|--|--| | | General Information | | | | | | | | | | 1. | 510(k) Number | K212914 | K192333 | - | | | | | | | 2. | Manufacturer | Glovmaster SDN. BHD. | JR Engineering & Medical<br>Technologies (M) SDN.BHD | - | | | | | | | 3. | Classification | I | I | Same | | | | | | | 4. | Regulation number | 21 CFR 880.6250 | 21 CFR 880.6250 | Same | | | | | | | 5. | Product Code | LZA | LZA | Same | | | | | | | 6. | Indication For Use | GLOVMASTER Nitrile Examination<br>Glove Powder Free is a disposable<br>device intended for medical<br>purpose that is worn on the<br>examiner's hand to prevent<br>contamination between patient<br>and examiner. | JR Medic Blue Nitrile Examination<br>Gloves Powder Free is disposable<br>devices intended for medical<br>purpose that are worn on the<br>examiner's hand to prevent<br>contamination between patient<br>and examiner. | Same | | | | | | | 7. | Material | Nitrile | Nitrile | Same | | | | | | | 8. | Color | Blue | Blue | Same | | | | | | | 9. | Texture | Finger Texture | Finger texture | Same | | | | | | | 10. | Ambidextrous | Yes | Data Not available | - | | | | | | | 11. | Size | S, M, L, XL | XS, S, M, L, XL | Similar | | | | | | | 12. | OTC Use | Yes | Yes | Same | | | | | | | 13. | Reusability | Single use | Single use | Same | | | | | | | 14. | Sterility | Non- sterile | Non- sterile | Same | | | | | | ### Table 1: General Comparison {5}------------------------------------------------ | SI.<br>No | Features compared | Proposed Device | Predicate Device | Comparison | | |-----------|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|------| | 15. | Dimensions | Length Min 230 m<br>Width Min 95±10<br>Mm (for medium size) | Length Min 230 m<br>Width Min 95±10<br>Mm (for medium size) | Same | | | 16. | Thickness | Palm min 0.05 mm<br>Finger min 0.05 mm | Palm min 0.05 mm<br>Finger min 0.05 mm | Same | | | 17. | Physical Properties | Before Aging<br>Tensile Strength min 14 MPa<br>Ultimate Elongation Min 500%<br>After Aging<br>Tensile Strength min 14 MPa<br>Ultimate Elongation Min 400% | Before Aging<br>Tensile Strength min 14 MPa<br>Ultimate Elongation Min 500%<br>After Aging<br>Tensile Strength min 14 MPa<br>Ultimate Elongation Min 400% | Same | | | 18. | Detection of Holes | Passes AQL 2.5 | Passes AQL 1.5 | Similar | | | 19. | Powder Free Residue | ≤2 mg/glove | ≤2 mg/glove | Same | | | 20. | Biocompatibility Study | In Vitro Cytotoxicity | Under the conditions of the study, the device extract has a cytotoxic potential. | Under the conditions of the study, cytotoxic. Additional testing was performed to determine if this was a systemic toxicity concern. | Same | | | | Skin Sensitization | Under the conditions of the study not a sensitizer | Under the conditions of the study not a sensitizer | Same | | | | Skin Irritation | Under the condition of study not an irritant | Under the condition of study not an irritant | Same | | | | Acute systemic toxicity | Under the condition of study, the device extracts do not pose a systemic toxicity. | Under the condition of study, the device extracts do not pose a systemic toxicity. | Same | | | | Material mediated pyrogenicity | Under the conditions of the study, the device demonstrate a non-pyrogenic response. | Under the conditions of the study, the device did not demonstrate a material mediated Pyrogenicity response. | Same | There are no significant differences between the two products and are identical in terms of intended use, materials, design, manufacturing methods. # VII. PERFORMANCE DATA ### Non- Clinical Data A. #### Performance Tests 1. GLOVMASTER Nitrile Examination Glove Powder Free is subjected to the following performance tests according to the requirements of Guidance for Industry and FDA Staff - Medical Glove Guidance Manual and found to be safe and efficient with respect to its intended use: - Dimension - Physical property - Barrier property tests Detection of Holes in Medical Gloves - Powder Free Residue {6}------------------------------------------------ | SL<br>no | Title of<br>Test | Purpose<br>of Test | Reference<br>Source | Acceptance Criteria | | | Result | | | Pass/<br>Fail | |----------|-------------------------------|---------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------|---------------------|-------------------------------|-------------------------------|---------------------|--------------|--------------|---------------| | 1 | Physical<br>dimension<br>test | To<br>measure<br>the length,<br>width and<br>thickness<br>of gloves | ASTM<br>D6319-19<br>Standard<br>Specification<br>for Nitrile<br>Examination<br>Gloves for<br>Medical<br>Application | Size | Length | Width | Size | Length | Width | | | | | | | S | 230mm<br>min | 80<br>mm±10 | S | 248 mm | 85.61<br>mm | Pass | | | | | | M | | 95<br>mm±10 | M | 245.23<br>mm | 95.15<br>mm | Pass | | | | | | L | | 110<br>mm±10 | L | 248.07<br>mm | 105 mm | Pass | | | | | | XL | | 120<br>mm±10 | XL | 251.46<br>mm | 114.07<br>mm | Pass | | | | | | Thickness | | | Thickness | | | Pass/<br>Fail | | | | | | S | 0.05 mm<br>min | 0.05 mm<br>min | S | 0.07 mm | 0.11 mm | Pass | | | | | | M | | | M | 0.06 mm | 0.11 mm | Pass | | | | | | L | | | L | 0.06 mm | 0.11 mm | Pass | | | | | | XL | | | XL | 0.06 mm | 0.10 mm | Pass | | | | | | Tensile strength | | | Tensile strength | | | Pass/<br>Fail | | | | To test<br>tensile<br>strength<br>and<br>ultimate<br>elongation | ASTM<br>D6319-19<br>Standard<br>Specification<br>for Nitrile<br>Examination<br>Gloves for<br>Medical<br>Application | S | 14Mpa<br>Min for<br>all sizes | 14Mpa<br>Min for<br>all sizes | S | 33.60<br>MPa | 30.56<br>MPa | Pass | | 2 | Physical<br>property<br>test | | | M | | | M | 33.69<br>MPa | 32.05<br>MPa | Pass | | | | | | L | | | L | 32.78<br>MPa | 28.66<br>MPa | Pass | | | | | | XL | | | XL | 33.96<br>MPa | 32.20<br>MPa | Pass | | | | | | Ultimate Elongation | | | Ultimate Elongation | | | Pass/<br>Fail | | | | | | S | 500%<br>Min for<br>all sizes | 400%<br>Min for<br>all sizes | S | 521.53% | 483.84% | Pass | | | | | | M | | | M | 553.07% | 514.61% | Pass | | | | | | L | | | L | 526.15% | 504.61% | Pass | | | | | XL | | | XL | 524.61% | 496.15% | Pass | | # Table 2: Performance Testing Summary {7}------------------------------------------------ | SL<br>no | Title of<br>Test | Purpose<br>of Test | Reference<br>Source | Acceptance Criteria | Result | |----------|-----------------------------------|--------------------------------------------|------------------------------------------------------------------------------------------------------------------------|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 3 | Barrier<br>property<br>test | To detect<br>holes in<br>gloves | ASTM<br>D6319-19 /<br>ASTM<br>D5151-19<br>Standard<br>Test Method<br>for Detection<br>of Holes in<br>Medical<br>Gloves | AQL 2.5 | AQL 2.5<br>Pass | | 4 | Powder<br>free<br>residue<br>test | To test<br>residual<br>powder on<br>gloves | ASTM<br>D6124-06<br>(Reapproved<br>2017)<br>Standard<br>Test Method<br>for Residual<br>Powder on<br>Medical<br>Gloves | Size<br>S<br>M<br>L<br>XL | Residual powder<br>content<br>≤ 2Mg/ Glove<br>Size Residual powder content Pass/Fail<br>S 0.04 mg/glove Pass<br>M 0.30 mg/glove Pass<br>L 0.20 mg/glove Pass<br>XL 0.28 mg/glove Pass | ### 2. BIOCOMPATIBILITY The materials used in the GLOVMASTER Nitrile Examination Glove Powder Free are biocompatible based on the biocompatibility tests mentioned in the Guidance for Industry and FDA Staff - Medical Glove Guidance Manual: - In vitro Cytotoxicity - Skin Sensitization - Skin Irritation - Acute Systemic Toxicity - Material-Mediated Pyrogenicity These tests are performed according to ISO 10993-1:2018, Biological Evaluation of Medical Devices -Part 1, Evaluation and Testing within a Risk Management Process. | Table 3: Biocompatibility Test Summary | | |----------------------------------------|--| |----------------------------------------|--| | SL<br>no | Title of Test | Purpose of<br>Test | Reference<br>Source | Acceptance<br>Criteria | Result | |----------|--------------------------|---------------------------------------------|-----------------------|------------------------|---------------------------------------------------------------------------------------| | 1 | In Vitro<br>Cytotoxicity | | ISO 10993-<br>5:2009 | Non cytotoxic | Under the conditions of the study,<br>the device extract has a<br>cytotoxic potential | | 2 | Skin<br>Sensitization | To ensure the<br>device is<br>biocompatible | ISO 10993-<br>10:2010 | Non sensitizer | Under the conditions of the study not a<br>sensitizer | | 3 | Skin Irritation | | ISO 10993-<br>10:2010 | Non irritant | Under the condition of study not an<br>irritant | {8}------------------------------------------------ | SL<br>no | Title of Test | Purpose of<br>Test | Reference<br>Source | Acceptance<br>Criteria | Result | |----------|---------------------------------------|----------------------------|--------------------------|------------------------|-------------------------------------------------------------------------------------------| | 4 | Acute<br>Systemic<br>Toxicity | To ensure the<br>device is | ISO 10993-<br>11:2017 | Non toxic | Under the condition of study, the<br>device extracts do not pose a systemic<br>toxicity. | | 5 | Material-<br>Mediated<br>Pyrogenicity | device is<br>biocompatible | ISO 10993-<br>11:2017(E) | Non pyrogenic | Under the conditions of the study, the<br>device demonstrate a non-pyrogenic<br>response. | #### 3. STERILISATION Sterilization study was not conducted as GLOVMASTER Nitrile Examination Glove Powder Free is provided non-sterile. #### 4. SHELF LIFE Shelf life is not claimed for GLOVMASTER Nitrile Examination Glove Powder Free. #### B. CLINICAL TEST DATA Clinical study was not conducted, as clinical data is not needed for GLOVMASTER Nitrile Examination Glove Powder Free. ## VIII. CONCLUSION The conclusion drawn from the non-clinical tests demonstrate that the subject device, GLOVMASTER Nitrile Examination Glove Powder Free are as safe, as effective and perform as well as or better than legally marketed predicated device in K192333.