Powder-Free Nitrile Examination Glove, Non-Sterile

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July 23, 2022 GoodGloves Industries Sdn Bhd % Prithul Bom Most Responsible Person Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k Saint Paul, Minnesota 55114 Re: K221877 Trade/Device Name: Powder-Free Nitrile Examination Glove, Non-Sterile Regulation Number: 21 CFR 880.6250 Regulation Name: Non-powdered patient examination glove Regulatory Class: Class I, reserved Product Code: LZA Dated: June 27, 2022 Received: June 28, 2022 Dear Prithul Bom: 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. 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 Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K221877 Device Name Powder Free Nitrile Examination Glove, Non Sterile Indications for Use (Describe) The Powder-Free Nitrile Examination Gloves, Non-Sterile (Blue) is a disposable device intended for medical purposes that is worn on the examiner's hand 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}------------------------------------------------ # 510K SUMMARY - K221877 #### 1.0 Submitter: | Name: | Yee Kam Lin | |------------|-------------------------------------------------------------------------------------------------------------------------------------------------------| | Address: | GoodGloves Industries Sdn Bhd<br>PT 12678, Jalan Techvalley 2, Sendayan Techvalley, Bandar<br>Sri Sendayan, 71950 Seremban, Negeri Sembilan, Malaysia | | Phone No.: | 06-781 8888 | Date of Summary Prepared: July 21, 2022 #### 2.0 Device Description | Common Name | : | Powder-Free Nitrile Examination Gloves | |------------------------------|---|-------------------------------------------------------------| | Trade/Proprietary<br>Name | : | Powder Free Nitrile Examination Glove, Non-Sterile | | Device Classification | : | Class I | | Classification<br>Regulation | : | 21 CFR 880.6250 (Non-Powdered Patient Examination<br>Glove) | | Product Code | : | LZA (Polymer Patient Examination Glove) | The Powder-Free Nitrile Examination Gloves, Non-Sterile (Blue) is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. The device is for over-the-counter use and single use only. The Powder-Free Nitrile Examination Gloves, Non-Sterile (Blue) is made of Nitrile, a synthetic rubber copolymer of acrylonitrile and butadiene. The device does not incorporate powder for purpose other than manufacturing. The final finished alove includes only residual powder from manufacturing. The Powder-Free Nitrile Examination Gloves, Non-Sterile is finishing through polymer coating process. The device is provided non-sterile. # 3.0 Summary of the Technological Characteristics Comparison of the device: The Powder Free Nitrile Examination Glove, Non-Sterile, meets minimal thickness of 0.06 mm and minimal length of 230 mm respectively. {4}------------------------------------------------ # Non-Clinical Bench Performance Testing Comparison | CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE | | COMPARISON<br>ANALYSIS | |-----------------------------------------------------------|------------|-------------------------------------------------------|--------------------------------|----------------------------------------------| | | | PREDICATE | CURRENT | | | | | BLUE | BLUE | | | 510(k) Number | - | K192333 | - | - | | Manufacturer(s) | - | JR Engineering & Medical<br>Technologies (M) SDN.BHD. | Goodgloves Industries Sdn Bhd | - | | Material | ASTM D6319 | Nitrile | Nitrile | Same | | Color | - | Blue | Blue | Same | | Physical Properties | ASTM D6319 | Meets | Meets | | | Before Aging<br>Tensile Strength:<br>Ultimate Elongation: | | 28Mpa min<br>500% min | 14.00 MPa min<br>500% min | Different but<br>within the ASTM<br>standard | | After Aging<br>Tensile Strength:<br>Ultimate Elongation: | | 30Mpa min<br>480% min | 14.00 MPa min<br>400% min | Different but<br>within the ASTM<br>standard | | Thickness :<br>- Finger<br>- Palm<br>- Cuff | ASTM D6319 | 0.10mm<br>0.06mm<br>0.04mm | 0.05mm min<br>0.05mm min<br>NA | Different but<br>within the ASTM<br>standard | | Powder Free | ASTM D6124 | Less than 2mg per glove | Less than 2mg per glove | Same | {5}------------------------------------------------ | CHARACTERISTICS | STANDARDS | PREDICATE | CURRENT | COMPARISON<br>ANALYSIS | |------------------|------------------------------------------------------------------------------------------------------------------------------------------------|-------------------|----------------------------------------------------------------------------------------------------------------------------|------------------------| | | | BLUE | BLUE | | | Biocompatibility | Primary Skin Irritation<br>- ISO 10993-10:2010<br>(E) & Consumer<br>Product Safety<br>Commission Title 16.<br>Chapter II, Part 1500 | Non Irritating | All animals were survived and<br>no abnormal signs were<br>observed during the study. | Similar | | | Dermal Sensitization-<br>ISO 10993-10: 2010<br>(E) & Consumer<br>Product Safety<br>Commission, Title 16,<br>Chapter II, Part<br>1500.3 (c) (4) | Non Sensitization | No skin sensitization reaction<br>was found in the skin of guinea<br>pig, and the positive rate of<br>sensitization was 0% | Similar | | | Cytotoxicity - MEM<br>Elution, ISO 10993-5:<br>2009 (E) | Non Cytotoxic | Findings suggest that the test<br>samples and control sample is<br>not toxic for cell growth. | Similar | {6}------------------------------------------------ | | DEVICE PERFORMANCE | | | | |---------------------|-------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------| | CHARACTERISTICS | STANDARDS | PREDICATE | CURRENT | COMPARISON<br>ANALYSIS | | | | BLUE | BLUE | | | Biocompatibility | Acute Systemic<br>Toxicity, ISO 10993-<br>11:2017 (E) | Not Available | There was no evidence of<br>systemic toxicity from the<br>extract | Different | | Watertight (1000ml) | ASTM D5151:2019 | Inspection Level 1, AQL 1.5 | Inspection Level 1, AQL 1.5 | Same | | Intended use | | A patient examination glove is a<br>disposable device intended for<br>medical purposes that is worn<br>on the examiner's hand to<br>prevent contamination between<br>patient and examiner. | A patient examination glove is<br>a disposable device intended<br>for medical purposes that is<br>worn on the examiner's hand<br>or finger to prevent<br>contamination between patient<br>and examiner. | Same | | Size | Medical Glove<br>Guidance Manual –<br>Labeling | X Small<br>Small<br>Medium<br>Large<br>Extra Large | Small<br>Medium<br>Large<br>Extra Large | Different | | Single use | Medical Glove<br>Guidance Manual –<br>Labeling | Single use | Single use | Same | There are no significant differences between the two products and are identical in terms of intended use, manufacturing methods except for size, physical properties and thickness. The current device is blue in color and thicker than predicate device. # 4.0 Summary of Non-Clinical testing The performance test data of the non-clinical test for this powder free nitrile examination glove is summarized as below. {7}------------------------------------------------ | Test<br>Method | Standard | Purpose of Testing | Acceptance Criteria | | Results | | Status | | |------------------------|------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------|------------------------|-----------------|-----------------|-------------|----------|------| | | | | Before aging | After aging | Before aging | After aging | | | | Physical<br>Properties | ASTM D412<br>(Standard Test<br>Method for<br>Vulcanized Rubber<br>and Thermoplastic<br>Elastomers-Tension) | To evaluate the<br>tensile (tension)<br>properties of glove. | Tensile<br>strength | Min 14.0<br>MPa | Min 14.0<br>MPa | 14.0<br>MPa | 14.0 MPa | Pass | | | | | Ultimate<br>elongation | Min<br>500% | Min<br>400% | Min 500% | Min 400% | Pass | | Test<br>Method | Standard | Purpose of<br>Testing | Acceptance Criteria | Results | Status | |----------------------------|-------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|------------------------------| | Dimension | ASTM D3767<br>Standard Practice for<br>Rubber—<br>Measurement of<br>Dimensions | To measure the<br>length, width and<br>thickness of<br>glove | Length<br>Min 230 mm<br><br>Width<br>Min 95 ± 10 mm<br><br>Thickness<br>Finger – 0.05 mm<br>Palm – 0.05 mm<br>Cuff - NA | Length<br>Min 230 mm<br><br>Width<br>Min 95±10 mm<br><br>Thickness<br>Finger – 0.05 mm<br>Palm – 0.05 mm<br>Cuff - NA | Pass<br><br>Pass<br><br>Pass | | Test Method | Standard | Purpose of<br>Testing | Acceptance Criteria | Results | Status | | Residual<br>Powder | ASTM D6124<br>(Standard Test<br>Method for Residual<br>Powder on Medical<br>Gloves) | To determine the<br>amount of<br>residual powder<br>and non-powder<br>solids found on<br>gloves. | Less than 2 mg per glove | Sample size : 5 pcs<br>Requirement : <2mg/glove<br>Result<br>: 1.2 mg/glove | Pass | | Skin<br>Sensitization | Dermal<br>Sensitization- ISO<br>10993-10: 2010 (E) | To determine<br>whether the<br>subject device is a<br>sensitizer. | Magnusson and Kligman<br>grades of less than 1 | Non- Sensitizer to Guinea<br>Pigs. | Pass | | Skin Irritation | Primary Skin<br>Irritation - ISO<br>10993-10:2010 (E) | To determine<br>whether the<br>subject device is<br>an irritant. | Primary or Cumulative<br>Irritation Index (PII) of 0.4<br>or less | Non-irritant in New Zealand<br>White Rabbits | Pass | | Cytotoxicity | Cytotoxicity - MEM<br>Elution, ISO 10993-<br>5: 2009 (E) | To determine<br>whether the<br>subject device is<br>cytotoxic. | Reactivity grade should not<br>be greater than grade 2 or<br>should show "mild<br>reactivity". | Non-Cytotoxic on Hela Cells | Pass | | Acute Systemic<br>Toxicity | Acute Systemic<br>Toxicity, ISO 10993-<br>11:2017 (E) | To determine<br>whether the<br>subject device<br>causes a systemic<br>response. | 1. No animals showed a<br>significantly greater<br>biological reactivity than<br>animals treated with solvent<br>control.<br><br>2. None showed body weight<br>loss > 10%.<br><br>3. No mortality or abnormal<br>behavior such as conclusions<br>or prostration occurred in<br>the control group animals. | Does not induce any<br>systemic toxicity in Swiss<br>albino mice | Pass | {8}------------------------------------------------ {9}------------------------------------------------ # 5.0 Summary of Clinical Summary # Clinical testing is not needed for this device and review. # 6.0 Conclusion The conclusion drawn from the non-clinical tests demonstrate that the subject Powder Free Nitrile Examination Gloves, Non Sterile, is as safe, as effective, and performs as well as or better than the legally marketed predicate devices K192333.