Disposable Powder Free Polyethylene Examination Gloves

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May 31, 2022 Mastermax Plastic (Huizhou) LTD % Tracy Che Registration Engineer Feiying Drug & Medical Consulting Technical Service Group Rm 2401 Zhenye International Business Center, No. 3101-90 Oianhai Road Shenzhen, Guangdong 518100 China Re: K212699 Trade/Device Name: Disposable Powder Free Polyethylene Examination Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I. reserved Product Code: LZA Dated: April 26, 2022 Received: May 2, 2022 Dear Tracy Che: 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. 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) K212699 Device Name Disposable Powder Free Polyethylene Examination Gloves Indications for Use (Describe) Disposable Powder Free Polyethylene Examination Gloves are powder free and non-sterile disposable devices intended for medical purposes that are worn on the examiner's hand 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}------------------------------------------------ # K212699 # 510k Summary This 510(k) Summary is submitted in accordance with requirements of Title 21, CFR Section 807.92. ## (1) Applicant information: | 510(k) owner's name: | Mastermax Plastic (Huizhou) LTD | |---------------------------|---------------------------------------------------------------------------------| | Address: | No.1, Qingli 3rd Road, Shuikou, Huicheng district, Huizhou,<br>Guangdong, China | | Contact person: | Benson Xu | | Phone number: | +86-752-2315076 | | Email: | Bensonmastermax1@126.com | | Date of summary prepared: | 2022-5-24 | #### (2) Proprietary name of the device | Trade name/model: | Disposable Powder Free Polyethylene Examination Gloves | |--------------------|--------------------------------------------------------| | Common name: | Polymer Patient Examination Glove | | Regulation number: | 21 CFR 880.6250 | | Product code: | LZA | | Review panel: | General Hospital | | Regulation class: | Class I | #### (3) Predicate device | Sponsor | Jiangsu U-MED Rubber & Plastic Products Co.,Ltd. | |-----------------------|---------------------------------------------------------------| | Device Name and Model | U-MED Powder Free Polyethylene Examination Gloves, Blue Color | | 510(k) Number | K173228 | | Product Code | LZA | | Regulation Number | 21 CFR 880.6250 | | Regulation Class | Class I | # (4) Description/ Design of device: The Disposable Powder Free Polyethylene Examination Gloves are non-sterile disposable patient examination glove. The gloves are made of translucent (clear), low density polyethylene material and are powder free. The Disposable Powder Free Polyethylene Examination Gloves come in four sizes: Small, Medium, Large, X Large. The Disposable Powder Free Polyethylene Examination Gloves act as a barrier to prevent {4}------------------------------------------------ contamination between patient and examiner. The physical and performance characteristics of the device meets all requirements of ASTM D5250 and ASTM D5151. ### (5) Indications for use: Disposable Powder Free Polyethylene Examination Gloves are powder free and non-sterile disposable devices intended for medical purposes that are worn on the examiner's hand or finger to prevent contamination between patient and examiner. | Item | Subject device | Predicate device | Comparison | | |------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------| | Company | Mastermax Plastic (Huizhou) LTD | Jiangsu U-MED Rubber &<br>Plastic Products Co.,Ltd | / | | | Trade name | Disposable Powder Free<br>Polyethylene Examination<br>Gloves | U-MED Powder Free<br>Polyethylene Examination<br>Gloves, Blue Color | / | | | 510 (k) number | K212699 | K173228 | / | | | Regulation<br>number | 21CFR 880.6250 | 21 CFR 880.6250 | Same | | | Product code | LZA | LZA | Same | | | Size | Small/ Medium/ Large/X large | Small/ Medium/ Large/X large | Same | | | Class | I | I | Same | | | Indications for<br>use / Intended<br>use | Disposable Powder Free<br>Polyethylene Examination<br>Gloves are powder free and<br>non-sterile disposable devices<br>intended for medical purposes<br>that are worn on the<br>examiner's hand or finger to<br>prevent contamination<br>between patient and examiner. | Powder Free Polyethylene<br>Examination Gloves, Blue<br>Color is a non-sterile<br>disposable device intended for<br>medical purposes that is worn<br>on the examiner's hand or<br>finger to prevent<br>contamination between patient<br>and examiner. | Similar | | | Device<br>Description and<br>Specifications | Meets ASTM D5250-19 | Meets ASTM D5250-06<br>(Reapproved 2015) | Similar | | | Dimensions:<br>Overall length,<br>Width,<br>Palm and Finger<br>thickness | Meets ASTM D5250-19 | Meets ASTM D5250-06<br>(Reapproved 2015) | Similar | | | Item | Proposed device | Predicate device | Remark | | | Physical<br>Properties<br>Tensile Strength<br>before<br>aging/after<br>aging | Meets ASTM D5250-19 | Meets ASTM D5250-06<br>(Reapproved 2015) | Similar | | | Ultimate<br>Elongation<br>before<br>aging/after<br>aging | Meets ASTM D5250-19 | Meets ASTM D5250-06<br>(Reapproved 2015) | | | | Freedom from<br>Pinholes<br>Holes | Holes at<br>Inspection Level I<br>AQL2.5 | Holes at<br>Inspection Level I<br>AQL2.5 | Same | | | Residual<br>Powder | Meets ASTM D5250-19 | Meets ASTM D5250-06<br>(Reapproved 2015) | Similar | | | Materials used<br>to fabricate the<br>devices | Polyethylene | Polyethylene | Same | | | Color | Translucent [clear] | Blue color | Different | | | Performance<br>Data Standard | Meets ASTM D5151-19<br>ASTM D5250-19<br>ASTM D6124-06<br>(Reapproved 2017) | Meets ASTM D5151-06<br>(Reapproved 2015)<br>ASTM D5250-06<br>(Reapproved 2015)<br>ASTM D6124-06<br>(Reaffirmation 2011) | Similar | | | Single Patient<br>Use | Single Patient Use | Single Patient Use | Same | | | Biocompatibility | Under the conditions of this<br>study, not have cytotoxicity<br>and<br>Under the conditions of this<br>study, not an irritant and<br>Under the conditions ofthis | Under the conditions of this<br>study, not an irritant and Under<br>the conditions of this study,<br>not a sensitizer.<br>SKIN IRRITATION | Similar | | | Item | Proposed device | Predicate device | Remark | | | | study, not a sensitizer.<br>SKIN IRRITATION<br>and SENSITIZATION<br>STUDIES Meet ISO<br>10993-10: 2010<br>In Vitro Cytotoxicity Meets<br>ISO 10993-5: 2009 | DERMAL and<br>SENSITIZATION STUDIES<br>Meets ISO 10993-10 Third<br>Edition 2010-08-01 | | | | | Labeling | There are no special labeling<br>claims and we do not claim<br>our gloves as hypoallergenic<br>on our labels.<br>-Powder Free<br>-Patient Examination Glove<br>-Single Use Only<br>-Lot<br>Shelf life of 3 years | There are no special labeling<br>claims and we do not claim<br>our gloves as hypoallergenic<br>on our labels.<br>-Powder Free<br>-Patient Examination Glove<br>-Single Use Only<br>- Manufactured For:<br>- Lot | Similar | (6) Technological Characteristics Comparison: {5}------------------------------------------------ {6}------------------------------------------------ # (7) Summary of the Technological Characteristics of the Device: Disposable Powder Free Polyethylene Examination Gloves are summarized with the following technological characteristics compared to ASTM or equivalent standard. | Characteristics | Standard | |-----------------------|--------------------------------------------------------------------------------------------------------| | Dimension | ASTM D 5250-19 | | | Length $\geq$ 230mm | | | Width | | | Small 85±5mm | | | Medium 95±5mm | | | Large 105±5mm | | | X large 115±5mm | | | Thickness | | | Finger $\geq$ 0.08mm | | | Palm $\geq$ 0.08mm | | Physical Properties | ASTM D 5250-19 | | | Tensile strength (Before & After aging) $\geq$ 11MPa | | | Elongated rate (Before & After aging) $\geq$ 300% | | Freedom from pinholes | <br>● ASTM D5250-19 Passed Standard<br>● ASTM D5151-19 Acceptance Criteria | | Powder Residual | ASTM standard D5250-19 and D6124-06<br>(Reapproved 2017) Meets <2mg/glove | | Biocompatibility | In Vitro Cytotoxicity MTT method ISO 10993-5: 2009 Pass<br>Under the experimental conditions, the test | {7}------------------------------------------------ | | | article has no potential<br>toxicity to L-929 in the<br>MTT method. | |--|------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------| | | Skin Irritation in rabbits ISO 10993-10: 2010 | Pass<br>Under the experimental<br>conditions, the test<br>article has no potential<br>skin irritation on rabbit in<br>the extraction method. | | | Skin sensitization in the guinea pig ISO<br>10993-10: 2010 | Pass<br>Under the experimental<br>conditions, the test<br>article has no potential<br>skin sensitization on<br>guinea pigs in the<br>extraction method. | #### (8) Non-Clinical Performance Data: The Disposable Powder Free Polyethylene Examination Gloves meet requirements per ASTM D5250-19, per ASTM D 5151-19, per ASTM D6124-06 (Reapproved 2017), ISO 10993-5: 2009 and ISO 10993-10: 2010. Those verification tests of gloves were performed by qualified test center according to the above standards and included dimensions, tensile strength (before & after aging) & elongated rate (before & after aging), powder residual, water leak testing, and biocompatibility. The overall results of the testing demonstrated that the subject glove passed testing performed according to ASTM D5250-19. Tensile strength (Before & After aging) was demonstrated as more than 11MPa, elongated rate (before & after aging) was demonstrated as more than 300%, powder residual was demonstrated as less than 2mg/glove. The subject glove also did not raise any biocompatibility concerns when tested according to ISO 10993-5 and ISO 10993-10. The detailed information for the non-clinical testing performed can be seen in corresponding test reports and are summarized as the following table. | Test Method | Purpose | Acceptance criteria | Results | |---------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Dimension<br>ASTM D 5250-19 | To evaluate the<br>physical dimension of<br>the gloves. | Length: $\geq$ 230mm;<br>Width:<br>Small 85 $\pm$ 5mm<br>Medium 95 $\pm$ 5mm<br>Large 105 $\pm$ 5mm<br>X large 115 $\pm$ 5mm;<br>Thickness: $\geq$ 0.08mm | Pass, the test results<br>meet the acceptance<br>criteria. | | | | (finger, palm) | | | Physical<br>Properties<br>ASTM D 5250-19 | To evaluate the<br>physical properties<br>(tensile strength and<br>elongated rate before<br>& after aging). | Before Aging<br>Tensile strength: ≥11MPa<br>Ultimate elongation: ≥300%;<br>After Aging<br>Tensile strength: ≥11MPa<br>Ultimate elongation: ≥300% | Pass, the test results<br>meet the acceptance<br>criteria. | | Freedom from<br>pinholes<br>ASTM D5250-19<br>ASTM D5151-19 | Detection of the holes<br>that allow water<br>leakage. | Do not show droplet,<br>stream or other type of<br>water leakage at<br>Inspection Level I<br>AQL2.5 | Pass, no leakage. | | Powder Residual<br>ASTM D5250-19<br>ASTM D6124-06<br>(Reapproved<br>2017) | To evaluate the<br>residual powder. | Less than 2.0mg/glove | Pass, the test results<br>meet the acceptance<br>criteria. | | In vitro<br>cytotoxicity ISO<br>10993-5 | To evaluate the<br>biological safety of the<br>product which has<br>direct contact with<br>intact skin. | The test article should not<br>have potential toxicity to<br>L-929 in the MTT<br>method. | Pass, the test article<br>has no potential<br>toxicity to L-929 in<br>the MTT method. | | Skin sensitization<br>ISO 10993-10 | To evaluate the<br>biological safety of the<br>product which has<br>direct contact with<br>intact skin. | The test article should not<br>cause delayed dermal<br>contact sensitization in the<br>guinea pig. | Pass, the test article<br>showed no evidence<br>of causing delayed<br>dermal contact<br>sensitization in the<br>guinea pig. The test<br>article has no<br>potential skin<br>sensitization on<br>guinea pigs in the<br>extraction method. | | Skin irritation | To evaluate the | The irritation response | Pass, the response of | | ISO 10993-10 | biological safety of the<br>product which has<br>direct contact with<br>intact skin. | category in the rabbit<br>should be negligible. | the test article extract<br>was categorized as<br>negligible under the<br>test condition. The<br>test article has no<br>potential skin<br>irritation on rabbit in<br>the extraction method. | {8}------------------------------------------------ {9}------------------------------------------------ ## (9) Clinical data Clinical performance testing was not needed for this device. # (10) Conclusion Based on the nonclinical tests performed, the subject device, Disposable Powder Free Polyethylene Examination Gloves, are as safe, as effective, and perform as well as or better than the legally marketed predicate device, K173228, U-MED Powder Free Polyethylene Examination Gloves, Blue Color.