Purism Non-Sterile Powder Free Nitrile Examination Gloves

{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 is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. August 19, 2021 Dezhou Purism Medical Technology Co., Ltd. % Natalya Valerio Consultant mdi Consultants, Inc. 55 Northern Blvd., Suite 201 Great Neck. New York 11021 Re: K211319 Trade/Device Name: Purism Non-Sterile Powder Free Nitrile Examination Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA Dated: July 14, 2021 Received: July 16, 2021 Dear Natalya Valerio: 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. For 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) K211319 Device Name Purism Non-sterile Powder Free Nitrile Examination Gloves Indications for Use (Describe) The Purism Non-sterile Powder Free Nitrile Examination Gloves 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}------------------------------------------------ # 510(k) SUMMARY The assigned 510(k) number is: K211319 Date Summary Prepared: August 3, 2021 ### 1. Submitter's Identification: Dezhou Purism Medical Technology Co., Ltd. High-end Equipment Manufacturing Park, Minsheng North Road, Economic Development Zone, Pingyuan County, Dezhou City, Shandong Province, 253100 China Tel: +86 15662735157 Contact Person: Mengqi Yang ### 2. Name of the Device: Device Trade Name: Purism Non-sterile Powder Free Nitrile Examination Gloves ### 3. Requlatory Information: | Regulation Name: | Non-Powdered Patient Examination Glove | |--------------------|----------------------------------------| | Regulatory Class: | Class I, reserved | | Product Code: | LZA | | Regulation Number: | 21 CFR 880.6250 | | Panel: | General Hospital | ### 4. Predicate Device Information: | 510(k) #: | K210057 | |---------------|----------------------------------------| | Device: | Blue Nitrile Exam Glove, Powder Free | | Manufacturer: | Real Star Medical Technology Co., Ltd. | ### 5. Device Description: The Purism Non-sterile Powder Free Nitrile Examination Gloves are a non-sterile, powder free, single use, disposable item. The gloves are made from nitrile compound and are blue in color. The gloves are ambidextrous and offered in Small, Medium, Large and X-Large sizes. {4}------------------------------------------------ ## 6. Indications for Use: The Purism Non-sterile Powder Free Nitrile Examination Gloves is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. # Z Technological Comparison to the 510(k) Cleared Predicate Device: | COMPARISON<br>CRITERIA | NEW DEVICE<br>510(K) # K211319 | PREDICATE DEVICE<br>510(K) # K210057 | COMPARISON<br>RESULT | |-------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------| | Device Name | Purism Non-sterile Powder<br>Free Nitrile Examination<br>Gloves | Blue Nitrile Exam Glove,<br>Powder Free | N/A | | Manufacturer | Dezhou Purism Medical<br>Technology Co., Ltd. | Real Star Medical<br>Technology Co., Ltd. | N/A | | Product Code | LZA | LZA | Same | | Classification | Class 1 | Class 1 | Same | | Regulation No. | 21 CFR 880.6250 | 21 CFR 880.6250 | Same | | Indications for<br>Use | The Purism Non-sterile<br>Powder Free Nitrile<br>Examination Gloves is a<br>disposable device intended<br>for medical purposes that is<br>worn on the examiner's<br>hand to prevent<br>contamination between<br>patient and examiner. | The Blue Nitrile Exam<br>Glove, Powder Free is a<br>non-sterile disposable<br>device intended for medical<br>purposes that is worn on the<br>examiner's hands or finger<br>to prevent contamination<br>between patient and<br>examiner. | Same | | Sterile or Non-<br>Sterile | Non-Sterile | Non-Sterile | Same | | Reusable or<br>Disposable<br>(Single Use) | Disposable (Singe Use) | Disposable (Single Use) | Same | | Design | Ambidextrous | Ambidextrous | Same | | Material of<br>Construction | Nitrile compound | Nitrile compound | Same | | Size | S, M, L, XL | S, M, L, XL | Same | | Color | Blue | Blue | Same | #### Table 1: Comparison to Predicate Device {5}------------------------------------------------ | Powdered or<br>Powder Free | Powder Free | | Powder Free | | Same | | | |---------------------------------------------|----------------------------------------------------------------------------------------------------|-----------------------|-----------------------|----------------------------------------------------------------------------------------------------|-----------------------|---------------|----------------------------------------------------------------------------| | Glove<br>Thickness | Size | Finger<br>(mm) | Palm<br>(mm) | Size | Finger<br>(mm) | Palm<br>(mm) | Similar<br>Both devices | | | S | $0.10\pm0.02$ | $0.06\pm0.02$ | S | $0.08\pm0.03$ | $0.08\pm0.03$ | are within | | | M | $0.10\pm0.02$ | $0.06\pm0.02$ | M | $0.08\pm0.03$ | $0.08\pm0.03$ | ASTM D6319-<br>19 | | | L | $0.10\pm0.02$ | $0.06\pm0.02$ | L | $0.08\pm0.03$ | $0.08\pm0.03$ | specifications | | | XL | $0.10\pm0.02$ | $0.06\pm0.02$ | XL | $0.08\pm0.03$ | $0.08\pm0.03$ | | | Glove<br>Dimensions | Size | Min<br>Length<br>(mm) | Palm<br>Width<br>(mm) | Size | Min<br>Length<br>(mm) | Width<br>(mm) | Similar<br>Both devices<br>are within<br>ASTM D6319- | | | S | 230 | $80\pm10$ | S | 230 | $80\pm10$ | 19 | | | M | 230 | $95\pm10$ | M | 230 | $95\pm10$ | specifications | | | L | 230 | $110\pm10$ | L | 230 | $110\pm10$ | | | | XL | 230 | $\ge110$ | XL | 230 | $120\pm10$ | | | Performance Testing | | | | | | | | | ASTM D6319-<br>19<br>Physical<br>Properties | Before Ageing<br>Tensile Strength<br>min 14 MPa<br>Ultimate Elongation<br>min 500%<br>After Ageing | | | Before Ageing<br>Tensile Strength<br>min 14 MPa<br>Ultimate Elongation<br>min 500%<br>After Ageing | | | Same | | | Tensile Strength<br>min 14 MPa<br>Ultimate Elongation<br>min 400% | | | Tensile Strength<br>min 14 MPa<br>Ultimate Elongation<br>min 400% | | | | | ASTM D5151-<br>19<br>Freedom from<br>Holes | Passed at AQL 1.5 | | | Passed at AQL 2.5 | | | Similar<br>Both devices<br>are within<br>ASTM D5151-<br>19<br>requirements | {6}------------------------------------------------ | ASTM D6124-<br>06<br>Residual<br>Powder | ≤2 mg/glove | ≤2 mg/glove | Same<br>Both devices<br>are within<br>ASTM D6124-<br>requirements | | |-----------------------------------------|--------------------------------------------------------|-----------------------------------------------------------------------------|-------------------------------------------------------------------|-----------| | ISO 10993<br>Biocompatibility | Primary Skin<br>Irritation<br>ISO 10993-<br>10:2010 | Under the<br>conditions of<br>study not an<br>Irritant | Under the conditions of<br>study not an irritant | Same | | | Dermal<br>Sensitization<br>ISO 10993-<br>10:2010 | Under the<br>conditions of<br>study not a<br>Sensitizer | Under the conditions of<br>study not a sensitizer | Same | | | In vitro<br>Cytotoxicity<br>ISO 10993-<br>5:2009 | Under the<br>conditions of<br>Study<br>Cytotoxic | Under the conditions of<br>study non-cytotoxic | Different | | | Acute<br>Systemic<br>Toxicity<br>ISO 10993-<br>11:2017 | Under the<br>conditions of<br>study did not<br>Show<br>Systemic<br>Toxicity | No data available | N/A | Both the Purism Non-sterile Powder Free Nitrile Examination Gloves and predicate Blue Nitrile Exam Glove, Powder Free are disposable, single use, non-sterile, powder free gloves intended for medical purposes to be worn on the examiner's hand to prevent contamination between patient and examiner. Both gloves are similar in color, design and sizes. Both gloves are made of nitrile compound. The only difference was in cytotoxicity test results where the Purism Non-sterile Powder Free Nitrile Examination Gloves showed cytotoxic properties under the conditions of the study. However, additional acute systemic toxicity testing performed under the ISO 10993-11:2017 supported the subject device was not systemically toxic. The results of primary skin irritation and dermal sensitization tests under the ISO 10993-10:2010 standard indicated the subject device was not an irritant or skin sensitizer. {7}------------------------------------------------ ## & Summary of Non-Clinical Tests Performed: The non-clinical performance testing completed for the Purism Non-sterile Powder Free Nitrile Examination Gloves demonstrated that the subject device met the acceptance criteria or specification for the applicable test methodology or standard as shown below. | Test Method | Purpose | Acceptance Criteria | Results | |------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------| | ASTM D6319-19<br>Standard<br>Specification for<br>Nitrile Examination<br>Gloves for Medical<br>Application | To determine glove<br>length | Min Length<br>(mm) | Avg Min Length<br>(mm) | | | | Size S: 230 | Size S: 236 (Pass) | | | | Size M: 230 | Size M: 239 (Pass) | | | | Size L: 230<br>Size XL: 230 | Size L: 241 (Pass)<br>Size XL: 238 (Pass) | | | To determine glove<br>palm width | Palm Width<br>(mm) | Avg Palm Width<br>(mm) | | | | Size S: 80±10 | Size S: 84 (Pass) | | | | Size M: 95±10 | Size M: 95 (Pass) | | | | Size L: 110±10<br>Size XL: ≥110 | Size L: 103 (Pass)<br>Size XL: 111 (Pass) | | | To determine glove<br>finger thickness | Finger Thickness<br>(mm) | Avg Finger<br>Thickness<br>(mm) | | | | Size S: 0.100±0.02 | Size S: 0.096 (Pass) | | | | Size M: 0.100±0.02 | Size M: 0.111 (Pass) | | | | Size L: 0.100±0.02<br>Size XL: 0.100±0.02 | Size L: 0.108 (Pass)<br>Size XL: 0.111 (Pass) | | | To determine glove<br>palm thickness | Palm Thickness<br>(mm) | Avg Palm Thickness<br>(mm) | | | | Size S: 0.060±0.02 | Size S: 0.058 (Pass) | | | | Size M: 0.060±0.02 | Size M: 0.066 (Pass) | | | | Size L: 0.060±0.02<br>Size XL: 0.060±0.02 | Size L: 0.074 (Pass)<br>Size XL: 0.080 (Pass) | | ASTM D6319-19<br>Standard<br>Specification for<br>Nitrile Examination<br>Gloves for Medical<br>Application | To determine glove<br>physical properties<br>before and after<br>ageing | Before Ageing<br>Tensile Strength<br>min 14 MPa<br>Ultimate Elongation<br>min 500% | Before Ageing<br>Tensile Strength<br>min 18.0 MPa (Pass)<br>Ultimate Elongation<br>min 694% (Pass) | | | | After Ageing | After Ageing | | | | Tensile Strength<br>min 14 MPa | Tensile Strength<br>min 18.2 MPa (Pass) | | | | Ultimate Elongation<br>min 400% | Ultimate Elongation<br>min 664% (Pass) | | ASTM D5151-19<br>Standard Test<br>Method for Detection<br>of Holes in Medical<br>Gloves | To detect holes and<br>check for water<br>leaks | As per ISO 2859-1.<br>GI Level II,<br>Lot Size 3000,<br>Sample Size 125,<br>AQL 1.5, Ac=5, Re=6 | Pass at AQL 1.5 | | ASTM D6124<br>Standard Test<br>Method for Residual<br>Powder on Medical<br>Gloves | To determine<br>residual powder | ≤2 mg/glove | 0.06 mg/glove (Pass) | ### Table 2: Non-Clinical Tests {8}------------------------------------------------ #### Table 3: Biocompatibility Tests | Test Method | Purpose | Acceptance Criteria | Results | |-------------------------------------------------|--------------------------------------------------------|----------------------------------------------------|----------------------------------------------------------------------| | Primary Skin<br>Irritation<br>ISO 10993-10:2010 | To determine if<br>device is a skin<br>irritant | The device must be a<br>non-irritant | Under the study<br>conditions not an<br>irritant | | Dermal Sensitization<br>ISO 10993-10:2010 | To determine if<br>device is a dermal<br>sensitizer | The device must be a<br>non-sensitizer | Under the study<br>conditions not a<br>sensitizer | | In vitro Cytotoxicity<br>ISO 10993-5:2009 | To determine if<br>device extract is<br>cytotoxic | The device must be<br>non-cytotoxic | Under the study<br>conditions cytotoxic | | Acute Systemic<br>Toxicity<br>ISO 10993-11:2017 | To determine if<br>device induces<br>systemic toxicity | The device must not<br>induce systemic<br>toxicity | Under the study<br>conditions did not<br>induce systemic<br>toxicity | #### 9. Discussion of Clinical Tests Performed: Clinical data are not required for marketing clearance of patient examination gloves. ### 10. Conclusion: The conclusion drawn from the nonclinical tests demonstrates that the subject device in 510(k) submission K211319, Purism Non-sterile Powder Free Nitrile Examination Gloves, is as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under K210057.