Violet Nitrile Powder Free Patient Examination Glove, Non Sterile

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October 18, 2022 Safeskin Retailing (HK) Limited % Stephan Toupan President Dawa Medical LLC 7320 NW 12th Street Suite 103 Miami, Florida 33126 Re: K222721 Trade/Device Name: Violet Nitrile Powder Free Patient 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: September 5, 2022 Received: September 8, 2022 Dear Stephan Toupan: 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. 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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. Bifeng Qian, M.D., 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 Ouality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K222721 Device Name VIOLET NITRILE POWDER-FREE PATIENT EXAMINATION GLOVE, NON STERILE Indications for Use (Describe) A nitrile patient examination glove is a disposable device made of nitrile rubber intended for medical purposes that is 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. 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The text "safeskin retailing" is in a bold, sans-serif font, with "safeskin" on the top line and "retailing" on the bottom line. # K222721 510K Summary Trade Name : Violet Nitrile Powder-free Patient Examination Glove, Non-Sterile {4}------------------------------------------------ | 1.0 | Submitter:<br>Name | : Alvin Ho | |-----|--------------------------|-----------------------------------------------------------------------------------------------------------------| | | Address | : Safeskin Retailing (HK) Limited<br>26th Floor, Beautiful Group Tower, 77 Connaught Road<br>Central, Hong Kong | | | Phone No. | : +6012 826 5625 | | | Date of Summary Prepared | : 12 October 2022 | #### 2.0 ldentification of the subject device: | Trade Name: | Violet Nitrile Powder-Free Patient Examination Glove, Non-Sterile | |-----------------------|-------------------------------------------------------------------| | Common Name: | Patient Examination Gloves | | Classification Name : | Patient Examination Gloves | | Device Classification | 1 | | Regulation Number : | 21 CFR 880.6250 | | Product Code | LZA | #### 3.0 Predicate Device: ### K143289 Non-Sterile, Powder Free Nitrile Examination Gloves - Violet Color Company: YTY Industry (Manjung) Sdn Bhd #### 4.0 Description of The Subject Device: Violet Nitrile Powder-Free Patient Examination Glove, Non-Sterile meets all requirements of ASTM D6319 standard and FDA 21 CFR 880.6250. The powder free nitrile examination glove is manufactured from nitrile rubber. Innersurface of gloves undergoes surface treatment process to produce a smooth surface that assists the user in donning the gloves with ease without using any lubricant such as powder or silicone on the glove surface. The glove is ambidextrous, i.e., can be worn on right or left hand. #### 5.0 Indication for use: A nitrile patient examination glove is a disposable device made of nitrile rubber intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner ### 6.0 ### Comparison of the Technological Characteristics of the Device: The Violet Nitrile Powder-Free Patient Examination Gloves, Non-Sterile are summarized with the following technological characteristics compared to ASTM D6319 or equivalent standards as shown in Table 1 {5}------------------------------------------------ ### Table 1 | CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE | | COMPARISON ANALYSIS | |-----------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------| | | | PREDICATE<br>K143289<br>VIOLET | CURRENT<br>K222721<br>VIOLET | | | 510(k) Number | - | K143289 | K222721 | | | Manufacturer(s) | - | YTY Industry (Manjung) Sdn Bhd. | Safeskin Retailing (HK) Limited | Same | | Material | ASTM D6319 | Nitrile | Nitrile | Same | | Color | - | Violet | Violet | Same | | Sterility | - | Non-Sterile | Non-Sterile | Same | | Handedness | - | Ambidextrous | Ambidextrous | Same | | Physical Properties | ASTM D6319 | | | | | | | | | | | Before Aging<br>Tensile Strength:<br>Ultimate Elongation: | - | 23.33 - 29.11Mpa<br>520 - 580% | 26.8 – 32.3 Mpa<br>520 - 600% | Different but<br>within the ASTM<br>standard | | After Aging Tensile<br>Strength:<br>Ultimate Elongation: | - | 27.39 - 30.82Mpa<br>440 - 500% | 30.6 – 35.3 Mpa<br>450 - 540 % | Different but<br>within the ASTM<br>standard | | Thickness:<br>- Finger<br>- Palm | ASTM D6319 | | | | | | | 0.09 - 0.11mm<br>0.06 - 0.07mm<br>0.05-0.06mm | Min 0.10mm for (XS, S, M, L XL)<br>Min 0.06mm for (XS, S, M, L XL) | Different but<br>within the ASTM<br>standard | | | | | | | | Powder Free | ASTM D6124 | Below 2mg of residual powder | Below 2mg of residual powder | Different but<br>within the ASTM<br>standard | | CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE | | COMPARISON ANALYSIS | | | | PREDICATE<br>K143289<br>VIOLET | CURRENT<br>K222721<br>VIOLET | | | Biocompatibility | Primary Skin Irritation<br>– ISO 10993-10:2010<br>(E) & Consumer<br>Product Safety<br>Commission Title 16.<br>Chapter II, Part 1500 | Under the conditions of this<br>study, the device is non-irritant<br>and non-sensitizer | Under conditions of this study, the<br>test material did not cause an<br>irritant response. The Primary<br>Irritant Response Category is<br>deemed 'Negligible' | Same | | Biocompatibility | Dermal Sensitization-<br>ISO 10993-10: 2010<br>(E) & Consumer Product<br>Safety Commission,<br>Title 16,Chapter II, Part<br>1500.3 (c) (4) | Under the conditions of this<br>study, the test device is non-<br>irritant and non-sensitizer. | Under conditions of this study,the<br>test material did not produce a skin<br>sensitization effect in the guinea<br>pigs. | Same | | Biocompatibility | Acute Systemic<br>Toxicity, ISO 10993-<br>11:2017 (E) | Not Tested | Under conditions of this study,the<br>test item did not induce any<br>systemic toxicity in Swiss albino<br>mice. | Different. The<br>subject glove was<br>tested using<br>systemic toxicity test<br>and passed, but the<br>Predicate did not<br>have the test<br>performed | | CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE | | COMPARISON ANALYSIS | | | | PREDICATE<br>K143289<br>VIOLET | CURRENT<br>K222721<br>VIOLET | | | Watertight (1000ml) | ASTM D5151:2019 | AQL 2.4<br>Result : 0 | Meets<br>• 21 CFR 800.20<br>• ASTM D6319-10<br>(Reapproved 2015)<br>Tested in accordance with ASTM<br>D5151 (Reapproved 2015) with<br>acceptable results<br>At an AQL 1.5 | Same | | Intended use / Indications<br>for use | - | A patient examination glove is a<br>disposable device intended for<br>medical purposes that is worn on<br>the examiners hand or finger to<br>prevent contamination between<br>patient and examiner | A Nitrile patient examination glove<br>is a disposable device made of<br>nitrile rubber intended for medical<br>purposes that is worn on the<br>examiner's hand or finger to<br>prevent contamination between<br>patient and examiner. | Similar | | Size | Medical Glove<br>Guidance Manual –<br>Labeling | Medium | Extra Small<br>Small<br>Medium<br>Large<br>Extra Large | Similar<br>The subject glove<br>has a size Extra<br>Small, the Predicate<br>does not | | Single use | Medical Glove<br>Guidance Manual –<br>Labeling | Single Use | Single Use | Same | {6}------------------------------------------------ {7}------------------------------------------------ {8}------------------------------------------------ There are no significant differences between the two devices. They are the same or similar in terms of intended use, primary material (Nitrile), design, physical properties, thickness, powder-free compliance, color, and biocompatibility assessments. #### Summary of Non-Clinical Testing 7.0 The performance test data of the non-clinical tests for this powder free nitrile examination glove is summarized as per below. {9}------------------------------------------------ | 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 Method<br>for 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 | XS – 28.8<br>S – 29.2<br>M – 28.0<br>L – 27.2<br>XL – 26.8 | XS – 30.8<br>S – 32.2<br>M – 31.0<br>L – 31.6<br>XL – 30.6 | Pass | | | | | Ultimate<br>elongation | Min<br>500% | Min<br>400% | XS – 520<br>S – 550<br>M – 540<br>L – 560<br>XL – 540 | XS – 460<br>S – 470<br>M – 480<br>L – 460<br>XL – 450 | Pass | {10}------------------------------------------------ | Test<br>Method | Standard | Purpose of<br>Testing | Glove<br>Size | Acceptance Criteria | Results | Status | | |----------------|----------------------------------------------------------------------------------|----------------------------------------------------------|---------------|----------------------------------|-----------|---------|------| | Dimension | ASTM D3767<br>Standard<br>Practice for<br>Rubber—<br>Measurementof<br>Dimensions | To measure the<br>length, width and<br>thickness ofglove | X-Small | Length<br> | 243 mm | Pass | | | | | | | Width<br>$70 \pm 10$ mm | 75.0 mm | Pass | | | | | | | Thickness<br>Finger - min 0.05mm | 0.10 mm | Pass | | | | | | | Palm - min 0.05mm | 0.06 mm | Pass | | | Small | Length<br>Min 240 mm | 243 mm | Pass | | | | | | | Width<br>$80 \pm 10$ mm | 85.0 mm | Pass | | | | | | | Thickness<br>Finger - min 0.05mm | 0.10 mm | Pass | | | | | | | Palm - min 0.05mm | 0.06 mm | Pass | | | | | | Medium | Length<br>Min 240 mm | 243 mm | Pass | | | | | | | Width<br>$95 \pm 10$ mm | 95.0 mm | Pass | | | | | | | Thickness<br>Finger - min 0.05mm | 0.10 mm | Pass | | | | | | | Palm - min 0.05mm | 0.06 mm | Pass | | | | | | Large | Length<br>Min 240 mm | 242 mm | Pass | | | | | | | Width<br>$110 \pm 10$ mm | 106 mm | Pass | | | | | | | | | Thickness | Finger – min 0.05mm | Thickness | 0.10 mm | Pass | | | | | | Palm - min 0.05mm | | 0.06 mm | | | | | | Length | Min 240 mm | Length | 248 mm | Pass | | | | X-Large | Width | $120 \pm 10$ mm | Width | 115 mm | Pass | | | | | Thickness | Finger – min 0.05mm | Thickness | 0.10 mm | Pass | | | | | | Palm - min 0.05mm | | 0.06 mm | | {11}------------------------------------------------ {12}------------------------------------------------ | Test<br>Method | Standard | Purpose of<br>Testing | Acceptance Criteria | Results | Status | |----------------|---------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------| | Watertight | ASTM D5151<br>(Standard Test<br>Method for<br>Detection of Holesin<br>Medical Gloves) | To detect holes<br>that leak water and<br>thereby<br>compromise the<br>usefulness of the<br>glove. | Sample size: 315 pcs<br>Inspection level: G1<br>AQL: 1.5, Acceptance No. 10 | The batch size for this<br>sampling is 150,001 to<br>500,000. Hence,<br>according to the single<br>sampling plan GI, the<br>sample to be drawn is<br>under code M equivalent<br>to 315 pieces with accept<br>10 and reject 11 to be<br>accepted under AQL<br>1.5.<br>For Size XS During the<br>test, 3piece was found<br>with leaks. Hence it falls<br>within the acceptance<br>criteria.<br>For Size S During the<br>test, 1piece was found<br>with leaks. Hence it falls<br>within the acceptance<br>criteria.<br>For Size M During the<br>test, 2piece was found<br>with leaks. Hence it falls<br>within the acceptance<br>criteria.<br>For Size L During the<br>test, 2piece was found<br>with leaks. Hence it falls<br>within the acceptance<br>criteria.<br>For Size XL During the<br>test, 1piece was found<br>with leaks. Hence it falls<br>within the acceptance<br>criteria. | Pass | {13}------------------------------------------------ | Test<br>Method | Standard | Purpose of<br>Testing | Acceptance Criteria | Results | | Status | |--------------------|----------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|------------------------------------------------------|-------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------|--------| | Residual<br>Powder | ASTM D6124<br>(Standard Test Method<br>for Residual Powder on<br>Medical Gloves) | To determine the<br>amount of residual<br>and non-powder<br>solids found on<br>gloves | Less than 2 mg per glove<br>Requirement : <2mg/glove | Sample size<br>Result<br>Result XS<br>Result S<br>Result M<br>Result L<br>Result XL | : 5 pcs<br>:0.33mg/glove<br>:0.28mg/glove<br>:0.26mg/glove<br>:0.30mg/glove<br>:0.40mg/glove<br>:0.34mg/glove | Pass | {14}------------------------------------------------ #### 8.0 Non-clinical performance testing methods full titles: - ASTM D412 Test Methods for Vulcanized Rubber and Thermoplastic Elastomers— O Tension - ASTM D573 Test Method for Rubber-Deterioration in an Air Oven x ASTM D3578 o Specification for Rubber Examination Gloves - ASTM D6319 Standard Specification for Nitrile Examination Gloves for Medical o Application - ASTM D5151 Test Method for Detection of Holes in Medical Gloves o - ASTM D6124 Test Method for Residual Powder on Medical Gloves O - ISO 2859 Sampling Procedures and Tables for Inspection by Attributes Test results show O that under the conditions of the testing, there is no difference inphysical attributes between the proposed device and the predicate device. #### Biocompatibility Testing utilizing: ISO 10993 Biological Evaluation ofMedical 9.0 Devices: - ISO 10993 Part 10: Tests for Irritation and Sensitization. Both Skin Irritation andDermal O Magnuson/Kligman Sensitization performed. - ISO 10993 Part 11: Tests for assessment of Systemic Toxicity O #### 10.0 Summary of Clinical Testing: No clinical studies are included in this submission. ### 11.0 Differences: There are no significant differences between the current glove and the predicate. They are identical in terms of their intended use, base materials, design, color, and manufacturing process. ### Conclusion The conclusion drawn from the non-clinical tests demonstrate that the subject device: Violet Nitrile Powder-Free Patient Examination Glove, Non-Sterile, is as safe, as effective, and performs as well as, or better than, the legally marketed predicate devices K143289.