(204 days)
The glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
Gloves have been tested for use with chemotherapy drugs and Fentanyl Citrate using ASTM D6978-05.
Powder Free Nitrile Patient Examination Gloves, Blue Colored, Non Sterile, Low Dermatitis Potential. Tested for Use with Chemotherapy Drugs and Fentanyl Citrate Are Class I Patient Examination Gloves and Specialty Chemotherapy Gloves. They are ambidextrous and come in different sizes - Extra Small, Small, Medium, Large, Extra Large and XXL.
Gloves meet the specification of ASTM D6319-19 and have been tested for resistance to permeation by chemotherapy drugs and Fentanyl Citrate as per ASTM D6978-05. The gloves are single use, disposable, and provided non-sterile.
Here's a breakdown of the acceptance criteria and the studies that prove the device meets them, based on the provided text:
Acceptance Criteria and Device Performance
The device in question is "Powder Free Nitrile Patient Examination Gloves, Blue Colored, Non Sterile, Low Dermatitis Potential. Tested for Use with Chemotherapy Drugs and Fentanyl Citrate" (K242533).
Non-Clinical Performance Data
| Methodology | Test Performed | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| ASTM D6319-19 | Physical Dimensions (Length) | Min 220mm for size XS, S; Min 230mm for size M-XXL | Pass |
| ASTM D6319-19 | Physical Dimensions (Palm Width) | XS: 70±10mm; S: 80±10mm; M: 95±10mm; L:110±10mm; XL: 120±10mm; XXL: 130±10mm | Pass |
| ASTM D6319-19 | Physical Dimensions (Thickness) | Finger: 0.05mm (min); Palm: 0.05mm (min) | Pass |
| ASTM D6319-19, ASTM D412-16 | Physical Properties (Tensile Strength & Elongation) | Tensile Strength (Min 14 MPa); Elongation (Before Aging 500% min and after aging 400% min) | Pass |
| ASTM D6319-19, ASTM D5151-19 | Water leak test | AQL 2.5 (ISO 2859-1) | Pass |
| ASTM D6319-19, ASTM D6124-06 | Powder Residue | Max 2mg/glove | Pass |
| ASTM D6978-05 | Permeation by Chemotherapy Drugs | As specified in the table for each drug (e.g., >240 minutes for most, with specific lower values for Carmustine and Thiotepa, explicitly stating "Do not use" for these). | Pass (as per specific BDTs) |
| ISO 10993-5:2009 | Cytotoxicity | No cytotoxicity reactivity (Note: The device states it is cytotoxic but this concern was addressed by acute systemic toxicity testing.) | The test article scored '4' at 24, 48, and 72 ± 4 hours and is considered cytotoxic under the conditions of this test. Cytotoxicity concern was addressed by acute systemic toxicity testing. |
| ISO 10993-10:2010 | Irritation and Skin Sensitization | No skin sensitization and Skin irritation | Under the conditions of this study, there were no evidence of sensitization and irritation. |
| ISO 10993-11:2017 | Acute systemic toxicity study | No adverse biological reaction | Under the conditions of this study, there was no evidence of acute systemic toxicity. |
Clinical Performance Data
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Modified DRAIZE-95 Test to Evaluate Low Dermatitis Potential of Medical Gloves | Demonstrate a reduced potential for sensitizing users to chemical additives. | Under the conditions of this clinical trial, the subject device demonstrated reduced potential for sensitizing users to chemical additives. |
Study Information
Due to the nature of the device (patient examination gloves) and the provided documentation, several sections of your request are not directly applicable or explicitly detailed. This document is a 510(k) summary for a Class I medical device, which typically relies more on performance testing against established standards and equivalence to predicates rather than complex clinical trials like those for novel therapeutic devices.
Here's what can be extracted from the document:
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Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Permeation Tests (ASTM D6978-05): The document does not specify the exact sample size used for the permeation tests for each chemical. The standard ASTM D6978-05 typically outlines the number of replicates required (e.g., three specimens).
- Biocompatibility Tests (ISO 10993 series): Similarly, the sample sizes for these tests are not explicitly stated in the summary but would be specified by the respective ISO standards.
- Clinical Test (Modified DRAIZE-95 Test): A 305-subject study was completed. The country of origin and whether it was retrospective or prospective is not specified, but such a test is typically prospective to evaluate a new or modified device.
- Data Provenance: The document generally refers to testing "under the conditions of this study," without specifying the country of origin for non-clinical tests. The manufacturer is based in China.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- For the non-clinical tests (physical properties, chemical permeation, biocompatibility), the "ground truth" is established by the standardized methods themselves (ASTM and ISO standards) and objective measurements by qualified laboratory personnel. The number of "experts" and their specific qualifications beyond standard lab certifications are not typically detailed in these summaries.
- For the clinical test on dermatitis potential, the "ground truth" is derived from the subjects' reactions as evaluated by the study investigators. The qualifications of these investigators are not provided.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- For the non-clinical tests, adjudication methods like 2+1 or 3+1 are not applicable. Results are based on objective measurements against defined criteria.
- For the clinical test (Modified DRAIZE-95), the document does not specify an adjudication method. Clinical studies of this nature usually involve clinical investigators observing and documenting reactions, and a statistical analysis of the aggregate results.
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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 physical product (gloves), not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies and AI assistance metrics are irrelevant.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is a physical device, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Physical and Chemical Tests: The ground truth is based on the objective measurements of the glove's properties (dimensions, strength, elongation, watertightness, powder residue) and breakthrough detection times for chemicals, all conducted according to recognized ASTM and ISO standards.
- Biocompatibility Tests: Ground truth is determined by the biological response observed in in vitro (cytotoxicity) or in vivo (irritation, sensitization, acute systemic toxicity) models as interpreted against the acceptance criteria of the ISO 10993 standards.
- Dermatitis Potential Clinical Test: The ground truth is the observed clinical reactions of human subjects to the device, evaluated against criteria for allergic contact sensitization.
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The sample size for the training set:
- Not applicable. This pertains to an algorithm or machine learning model. This device is a physical product.
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How the ground truth for the training set was established:
- Not applicable. As above, this is for an algorithm or machine learning model.
§ 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.