Nitrile Examination Gloves (Model: ZMG1351)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a sans-serif font. February 18, 2022 Wuhan Zonsen Medical Products Co.,Ltd % Doris Dong Manager Shanghai CV Technology Co., Ltd. Room 903, No.19 Dongbao Road, Songjiang Area Shanghai, Shanghai 201613 China Re: K213688 Trade/Device Name: Nitrile Examination Gloves (Model: ZMG1351) Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA Dated: November 10, 2021 Received: November 23, 2021 Dear Doris Dong: 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, 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) K213688 Device Name Nitrile Examination Gloves (Model: ZMG1351) Indications for Use (Describe) Nitrile Examination Gloves are disposable devices intended for medical purposes that are 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. 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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 [As required by 21 CFR 807.92] ## 1. Submission Information | 510(k) Number: | K213688 | |------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Date: | February 3rd, 2022 | | Type of 510(k) Submission: | Traditional 510(k) | | Basis for 510(k) Submission: | New device | | Submitter/Manufacturer: | Wuhan Zonsen Medical Products Co.,Ltd<br>No 8 Jinchao Road, Zhucheng Street, Xinzhou District, Wuhan City,<br>Hubei Province, China<br>Tel: +86-27-82737771<br>E-mail: Cynthia@zonsenmed.com | | Contactor: | Doris Dong<br>Shanghai CV Technology Co., Ltd.<br>Room 903, No. 19 Dongbao Road, Songjiang Area, Shanghai, 201613 China<br>E-mail: doris.d@ceve.org.cn<br>Tel: 86 21-31261348 / Fax: 86 21-57712250 | # 2. Device Description | Proprietary Name: | Nitrile Examination Gloves | |----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Model: | ZMG1351 | | Size: | S, M, L, XL | | Classification Name: | Non-powdered patient examination glove | | Product Code: | LZA | | Device Class: | 1 | | Regulation Number: | 21 CFR 880.6250 | | Review Panel: | General Hospital | | Indications for use: | Nitrile Examination Gloves are disposable devices intended for medical purposes that are worn on the examiner's hand to prevent contamination between patient and examiner. | | Device Description: | Nitrile Examination Gloves are made from nitrile butadiene rubber that covers the hand up to the wrist. They are cuffed and equally wearable on either hand, free from differentiation between the left hand and the right. The device is available in four sizes, which are S, M, L, XL. It could be selected by the user depending on the size of hand. All sizes share the same blue color. The gloves are non-sterile, powder free and are for single use only. | ## 3. Predicate Device Identification | 510(k) Number: | K211319 | |-------------------------|-----------------------------------------------------------| | Product Name: | Purism Non-Sterile Powder Free Nitrile Examination Gloves | | Submitter/Manufacturer: | Dezhou Purism Medical Technology Co., Ltd. | {4}------------------------------------------------ ## 4. Technological Characteristics Comparison | Parameters | New Device | Predicate Device | Comparison | |----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------| | 510(k) Number | K213688 | K211319 | --- | | 510(k) Owner | Wuhan Zonsen Medical Products<br>Co.,Ltd | Dezhou Purism Medical<br>Technology Co., Ltd. | --- | | Device Name | Nitrile Examination Gloves | Purism Non-Sterile Powder Free<br>Nitrile Examination Gloves | --- | | Model | ZMG1351 | / | --- | | Product Code | LZA | LZA | Same | | Regulation No. | 21 CFR 880.6250 | 21 CFR 880.6250 | Same | | Class | 1 | 1 | Same | | Intended use | Nitrile Examination Gloves are<br>disposable devices intended for<br>medical purposes that are worn<br>on the examiner's hand to prevent<br>contamination between patient<br>and examiner. | The Purism Non-Sterile Powder<br>Free Nitrile Examination Gloves<br>is disposable devices intended for<br>medical purposes that is worn on<br>the examiner's hand to prevent<br>contamination between patient<br>and examiner. | Same | | Material | Nitrile Butadiene Rubber Latex | Nitrile Butadiene Rubber Latex | Same | | Environment of<br>use | OTC | OTC | Same | | Design | Disposable (Single use) | Disposable (Single use) | Same | | | Non-sterile | Non-sterile | Same | | | Powder-free | Powder-free | Same | | | Ambidextrous | Ambidextrous | Same | | | Cuffed | Cuffed | Same | | Size | S, M, L, XL | S, M, L, XL | Same | | Color | Blue | Blue | Same | | Specifications | Powder-free Nitrile Examination<br>Gloves Meet ASTM D6319-19 | Powder-free Nitrile Examination<br>Gloves Meet ASTM D6319-19 | Same | | Dimensions<br>- Overall Length | Meets ASTM D6319-19<br>S: Min 220mm<br>M: Min 230mm<br>L: Min 230mm<br>XL: Min 230mm | Meets ASTM D6319-19<br>S: Min 230mm<br>M: Min 230mm<br>L: Min 230mm<br>XL: Min 230mm | Similar | | Dimensions<br>- Palm Width | Meets ASTM D6319-19<br>S: 80±10mm<br>M: 95±10mm<br>L: 110±10mm<br>XL: 120±10mm | Meets ASTM D6319-19<br>S: 80±10mm<br>M: 95±10mm<br>L: 110±10mm<br>XL: ≥110mm | | | Dimensions<br>- Finger Thickness | Meets ASTM D6319-19<br>Min 0.05mm | Meets ASTM D6319-19<br>Min 0.10±0.02mm | | | Dimensions<br>- Palm Thickness | Meets ASTM D6319-19<br>Min 0.05mm | Meets ASTM D6319-19<br>Min 0.06±0.02mm | | {5}------------------------------------------------ | Physical Properties | Meets ASTM D6319-19<br>Before Aging:<br>- Tensile Strength: min 14Mpa<br>- Ultimate Elongation: min 500%<br>Meets ASTM D6319-19<br>After aging:<br>- Tensile Strength: min 14Mpa<br>- Ultimate Elongation: min 400% | Meets ASTM D6319-19<br>Before Aging:<br>- Tensile Strength: min 14Mpa<br>- Ultimate Elongation: min 500%<br>Meets ASTM D6319-19<br>After aging:<br>- Tensile Strength: min 14Mpa<br>- Ultimate Elongation: min 400% | Same | |-----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------| | Freedom from<br>Holes | Meets ASTM D6319-19<br>Pass at AQL 2.5 | ASTM D5151-06<br>Pass at AQL 2.5 | Similar | | Powder residue | Meets ASTM D6319-19<br>Below 2mg/glove of residual<br>powder | Meets ASTM D6124-06<br>Below 2mg/glove of residual<br>powder | | | Biocompatibility | Meets ISO 10993-10:2010;<br><b>Skin Irritation:</b> Under the<br>condition of the test, not an<br>irritant.<br><b>Skin Sensitization:</b> Under the<br>condition of the test, not a<br>sensitizer.<br>Meets ISO 10993-11:2017;<br><b>Acute Systemic Toxicity:</b> Under<br>the condition of the test, not a<br>systemic toxicity. | Meets ISO 10993-10:2010;<br><b>Skin Irritation:</b> Under the<br>condition of the test, not an<br>irritant.<br><b>Skin Sensitization:</b> Under the<br>condition of the test, not a<br>sensitizer.<br>Meets ISO 10993-11:2017;<br><b>Acute Systemic Toxicity:</b> Under<br>the condition of the test, not a<br>systemic toxicity.<br>Meets ISO 10993-5:2009;<br><b>In Vitro Cytotoxicity:</b> Under the<br>condition of the test, cytotoxic | Similar | ### 5. Non-clinical Testing Summary Bench tests were conducted to verify that the proposed device met all design specifications. The test results demonstrated that the proposed device complies with the following standards: - ASTM D6319-19, Standard Specification for Nitrile Examination Gloves for Medical Application. - ISO 10993-10 Third Edition 2010-08-01, Biological Evaluation of Medical Devices - Part 10: Tests for Irritation and Skin Sensitization. - ISO 10993-11 Third edition 2017-09, Biological evaluation of medical devices - Part 11: Tests for systemic toxicity. | Test Method | Purpose | Acceptance Criteria | | Test Results | | |---------------------------------------|-----------------------------------------------------------------------|-------------------------------------------------------|-----------------------------------------------------------------|---------------------------------------------------------------|------------------------------------------------------------| | Dimension-<br>ASTM D6319-19 | Evaluate the<br>glove palm width | <i>Size</i> | (mm) | (mm) | | | | | S | $80\pm10$ | 84~86 | | | | | M | $95\pm10$ | 96~98 | | | | | L | $110\pm10$ | 104~106 | | | | | XL | $120\pm10$ | 113~115 | | | | Evaluate the | <i>Size</i> | (mm) | (mm) | | | | glove length | S | Min 220 | 241~251 | | | | | M | Min 230 | 236~249 | | | | | L | Min 230 | 237~245 | | | | | XL | Min 230 | 240~249 | | | | Evaluate the<br>glove finger<br>thickness | Size | (mm) | (mm) | | | | | S | Min 0.05 | 0.111~0.137 | | | | | M | Min 0.05 | 0.124~0.150 | | | | | L | Min 0.05 | 0.112~0.133 | | | | XL | Min 0.05 | 0.117~0.137 | | | | | Evaluate the<br>glove palm<br>thickness | Size | (mm) | (mm) | | | | | S | Min 0.05 | 0.080~0.097 | | | | | M | Min 0.05 | 0.087~0.098 | | | | | L | Min 0.05 | 0.074~0.086 | | | | XL | Min 0.05 | 0.077~0.094 | | | | Physical Properties-<br>ASTM D6319-19 | Evaluate the<br>glove physical<br>propertiesbefore<br>and after aging | <i>Before<br/>Aging</i> | <i>After aging</i> | <i>Before Aging</i> | <i>After aging at</i> | | | | Tensile<br>strength: | Tensile<br>strength: | Tensile<br>strength: | Tensile<br>strength: | | | | min 14Mpa | min 14Mpa | 19.9~27.4Mpa | 20.1~35.1Mpa | | | | Ultimate<br>elongation: | Ultimate<br>elongation: | Ultimate<br>elongation: | Ultimate<br>elongation: | | | | min 500% | min 400% | 509~553% | 454~504% | | | | Freedom from<br>Holes-<br>ASTM D6319-19 | Detect the holes<br>that allow water<br>leakage | Do not show droplet, stream or other type of<br>water leakage | | | | | | Powder residue-<br>ASTM D6319-19 | Evaluate the<br>residue powder | ≤2mg/glove | | | | | | Skin Irritation -<br>ISO 10993-10:2010 | Evaluated for the<br>potential to cause<br>skin irritation | | Sensitization -<br>ISO 10993-10:2010 | Evaluated for the<br>potential to cause<br>skin sensitization | Under the condition of the<br>test, not a sensitizer. | | | No- sensitization | | | Acute Systemic<br>Toxicity-<br>ISO 10993-11:2017 | Evaluated for<br>acute systemic<br>toxicity | Under the condition of the<br>test, not a systemic<br>toxicity. | | No- acute systemic toxicity | {6}------------------------------------------------ ### 6. Conclusion The conclusion drawn from the nonclinical tests demonstrates that the subject device in 510(k) submission, the Nitrile Examination Gloves, are as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under K211319.