(111 days)
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.
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.
The provided document describes the FDA's 510(k) clearance for the Purism Non-sterile Powder Free Nitrile Examination Gloves. It outlines the non-clinical tests performed to demonstrate that the device meets acceptance criteria.
Here's the breakdown of the information requested:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Method | Purpose | Acceptance Criteria | Reported Device Performance | Pass/Fail |
|---|---|---|---|---|
| ASTM D6319-19 (Dimensions) | To determine glove length | Min Length (mm): Size S: 230, Size M: 230, Size L: 230, Size XL: 230 | Avg Min Length (mm): Size S: 236, Size M: 239, Size L: 241, Size XL: 238 | Pass |
| To determine glove palm width | Palm Width (mm): Size S: 80±10, Size M: 95±10, Size L: 110±10, Size XL: ≥110 | Avg Palm Width (mm): Size S: 84, Size M: 95, Size L: 103, Size XL: 111 | Pass | |
| To determine glove finger thickness | Finger Thickness (mm): Size S: 0.100±0.02, Size M: 0.100±0.02, Size L: 0.100±0.02, Size XL: 0.100±0.02 | Avg Finger Thickness (mm): Size S: 0.096, Size M: 0.111, Size L: 0.108, Size XL: 0.111 | Pass | |
| To determine glove palm thickness | Palm Thickness (mm): Size S: 0.060±0.02, Size M: 0.060±0.02, Size L: 0.060±0.02, Size XL: 0.060±0.02 | Avg Palm Thickness (mm): Size S: 0.058, Size M: 0.066, Size L: 0.074, Size XL: 0.080 | Pass | |
| ASTM D6319-19 (Physical Properties) | To determine glove physical properties before and after ageing | Before Ageing: Tensile Strength min 14 MPa, Ultimate Elongation min 500% | Before Ageing: Tensile Strength min 18.0 MPa, Ultimate Elongation min 694% | Pass |
| After Ageing: Tensile Strength min 14 MPa, Ultimate Elongation min 400% | After Ageing: Tensile Strength min 18.2 MPa, Ultimate Elongation min 664% | Pass | ||
| ASTM D5151-19 | To detect holes and check for water leaks | As per ISO 2859-1. GI Level II, Lot Size 3000, Sample Size 125, AQL 1.5, Ac=5, Re=6 | Pass at AQL 1.5 | Pass |
| ASTM D6124 | To determine residual powder | ≤2 mg/glove | 0.06 mg/glove | Pass |
| ISO 10993-10:2010 (Primary Skin Irritation) | To determine if device is a skin irritant | The device must be a non-irritant | Under the study conditions not an irritant | Pass |
| ISO 10993-10:2010 (Dermal Sensitization) | To determine if device is a dermal sensitizer | The device must be a non-sensitizer | Under the study conditions not a sensitizer | Pass |
| ISO 10993-5:2009 (In vitro Cytotoxicity) | To determine if device extract is cytotoxic | The device must be non-cytotoxic | Under the study conditions cytotoxic | Fail |
| ISO 10993-11:2017 (Acute Systemic Toxicity) | To determine if device induces systemic toxicity | The device must not induce systemic toxicity | Under the study conditions did not induce systemic toxicity | Pass |
Note on Cytotoxicity: While the device showed cytotoxic properties in the in vitro test, the document states that additional acute systemic toxicity testing (ISO 10993-11:2017) supported that the device was not systemically toxic. The primary skin irritation and dermal sensitization tests also indicated the device was not an irritant or skin sensitizer. This suggests that the manufacturer provided sufficient evidence to mitigate concerns arising from the in vitro cytotoxicity result in the context of the device's intended use.
2. Sample size used for the test set and the data provenance
The document specifies "Sample Size 125" for the ASTM D5151-19 (Freedom from Holes) test, which is based on ISO 2859-1, GI Level II, and Lot Size 3000. For other tests like dimensions, physical properties, and biocompatibility, specific sample sizes are not explicitly stated in this summary, but the results are reported as average values, indicating that multiple samples were tested.
The provenance of the data (country of origin, retrospective/prospective) is not explicitly stated for each test. However, the manufacturer is "Dezhou Purism Medical Technology Co., Ltd." located in China, suggesting the testing was likely conducted in or overseen from China. The studies are non-clinical (laboratory-based) tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The tests performed are objective, standardized laboratory tests according to ASTM and ISO standards for medical gloves. They do not involve expert interpretation or ground truth establishment in the way clinical studies with human assessors would.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. As these are objective laboratory tests, there is no adjudication method involved. The results are quantitative measurements against predefined criteria.
5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a nitrile examination glove, not an AI-powered diagnostic tool, and therefore, MRMC studies are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical medical glove. The performance evaluation is based on its material properties and manufacturing quality, not an algorithm.
7. The type of ground truth used
The "ground truth" for the performance tests conducted (dimensions, physical properties, freedom from holes, residual powder, biocompatibility) is established by adherence to recognized international standards (ASTM D6319-19, ASTM D5151-19, ASTM D6124, ISO 10993-10:2010, ISO 10993-5:2009, ISO 10993-11:2017) and their specified acceptance criteria. These standards define the measurable properties that a glove must meet for its intended use.
8. The sample size for the training set
Not applicable. This device is a physical product and does not involve AI or machine learning, thus there is no "training set."
9. How the ground truth for the training set was established
Not applicable. There is no training set for this device.
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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.
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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
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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)
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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.
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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:
| COMPARISONCRITERIA | NEW DEVICE510(K) # K211319 | PREDICATE DEVICE510(K) # K210057 | COMPARISONRESULT |
|---|---|---|---|
| Device Name | Purism Non-sterile PowderFree Nitrile ExaminationGloves | Blue Nitrile Exam Glove,Powder Free | N/A |
| Manufacturer | Dezhou Purism MedicalTechnology Co., Ltd. | Real Star MedicalTechnology 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 forUse | The Purism Non-sterilePowder Free NitrileExamination Gloves is adisposable device intendedfor medical purposes that isworn on the examiner'shand to preventcontamination betweenpatient and examiner. | The Blue Nitrile ExamGlove, Powder Free is anon-sterile disposabledevice intended for medicalpurposes that is worn on theexaminer's hands or fingerto prevent contaminationbetween patient andexaminer. | Same |
| Sterile or Non-Sterile | Non-Sterile | Non-Sterile | Same |
| Reusable orDisposable(Single Use) | Disposable (Singe Use) | Disposable (Single Use) | Same |
| Design | Ambidextrous | Ambidextrous | Same |
| Material ofConstruction | 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
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| Powdered orPowder Free | Powder Free | Powder Free | Same | ||||
|---|---|---|---|---|---|---|---|
| GloveThickness | Size | Finger(mm) | Palm(mm) | Size | Finger(mm) | Palm(mm) | SimilarBoth 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 D6319-19 | |
| 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 | $0.08\pm0.03$ | $0.08\pm0.03$ | ||
| GloveDimensions | Size | MinLength(mm) | PalmWidth(mm) | Size | MinLength(mm) | Width(mm) | SimilarBoth devicesare withinASTM 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 D6319-19PhysicalProperties | Before AgeingTensile Strengthmin 14 MPaUltimate Elongationmin 500%After Ageing | Before AgeingTensile Strengthmin 14 MPaUltimate Elongationmin 500%After Ageing | Same | ||||
| Tensile Strengthmin 14 MPaUltimate Elongationmin 400% | Tensile Strengthmin 14 MPaUltimate Elongationmin 400% | ||||||
| ASTM D5151-19Freedom fromHoles | Passed at AQL 1.5 | Passed at AQL 2.5 | SimilarBoth devicesare withinASTM D5151-19requirements |
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| ASTM D6124-06ResidualPowder | ≤2 mg/glove | ≤2 mg/glove | SameBoth devicesare withinASTM D6124-requirements | |
|---|---|---|---|---|
| ISO 10993Biocompatibility | Primary SkinIrritationISO 10993-10:2010 | Under theconditions ofstudy not anIrritant | Under the conditions ofstudy not an irritant | Same |
| DermalSensitizationISO 10993-10:2010 | Under theconditions ofstudy not aSensitizer | Under the conditions ofstudy not a sensitizer | Same | |
| In vitroCytotoxicityISO 10993-5:2009 | Under theconditions ofStudyCytotoxic | Under the conditions ofstudy non-cytotoxic | Different | |
| AcuteSystemicToxicityISO 10993-11:2017 | Under theconditions ofstudy did notShowSystemicToxicity | 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.
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& 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 D6319-19StandardSpecification forNitrile ExaminationGloves for MedicalApplication | To determine glovelength | Min Length(mm) | Avg Min Length(mm) |
| Size S: 230 | Size S: 236 (Pass) | ||
| Size M: 230 | Size M: 239 (Pass) | ||
| Size L: 230Size XL: 230 | Size L: 241 (Pass)Size XL: 238 (Pass) | ||
| To determine glovepalm width | Palm Width(mm) | Avg Palm Width(mm) | |
| Size S: 80±10 | Size S: 84 (Pass) | ||
| Size M: 95±10 | Size M: 95 (Pass) | ||
| Size L: 110±10Size XL: ≥110 | Size L: 103 (Pass)Size XL: 111 (Pass) | ||
| To determine glovefinger thickness | Finger Thickness(mm) | Avg FingerThickness(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±0.02Size XL: 0.100±0.02 | Size L: 0.108 (Pass)Size XL: 0.111 (Pass) | ||
| To determine glovepalm thickness | Palm Thickness(mm) | Avg Palm Thickness(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±0.02Size XL: 0.060±0.02 | Size L: 0.074 (Pass)Size XL: 0.080 (Pass) | ||
| ASTM D6319-19StandardSpecification forNitrile ExaminationGloves for MedicalApplication | To determine glovephysical propertiesbefore and afterageing | Before AgeingTensile Strengthmin 14 MPaUltimate Elongationmin 500% | Before AgeingTensile Strengthmin 18.0 MPa (Pass)Ultimate Elongationmin 694% (Pass) |
| After Ageing | After Ageing | ||
| Tensile Strengthmin 14 MPa | Tensile Strengthmin 18.2 MPa (Pass) | ||
| Ultimate Elongationmin 400% | Ultimate Elongationmin 664% (Pass) | ||
| ASTM D5151-19Standard TestMethod for Detectionof Holes in MedicalGloves | To detect holes andcheck for waterleaks | As per ISO 2859-1.GI Level II,Lot Size 3000,Sample Size 125,AQL 1.5, Ac=5, Re=6 | Pass at AQL 1.5 |
| ASTM D6124Standard TestMethod for ResidualPowder on MedicalGloves | To determineresidual powder | ≤2 mg/glove | 0.06 mg/glove (Pass) |
Table 2: Non-Clinical Tests
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Table 3: Biocompatibility Tests
| Test Method | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| Primary SkinIrritationISO 10993-10:2010 | To determine ifdevice is a skinirritant | The device must be anon-irritant | Under the studyconditions not anirritant |
| Dermal SensitizationISO 10993-10:2010 | To determine ifdevice is a dermalsensitizer | The device must be anon-sensitizer | Under the studyconditions not asensitizer |
| In vitro CytotoxicityISO 10993-5:2009 | To determine ifdevice extract iscytotoxic | The device must benon-cytotoxic | Under the studyconditions cytotoxic |
| Acute SystemicToxicityISO 10993-11:2017 | To determine ifdevice inducessystemic toxicity | The device must notinduce systemictoxicity | Under the studyconditions did notinduce systemictoxicity |
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.
§ 880.6250 Non-powdered patient examination glove.
(a)
Identification. A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.(b)
Classification. Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.