(278 days)
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
It has also been tested for use against Fentanyl Citrate, ASTM D6978-05 (Reapproved 2019, Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs).
Drugs Tested: Fentanyl Citrate, 100mcg/2mL Breakthrough Time (Minutes) >240 min
The Medline Powder-Free Orange Nitrile Patient Examination Gloves (Tested for use with Fentanyl) are non-sterile, single use, disposable gloves intended for medical purposes to be worn on the hands of examiners to prevent contamination between a patient and an examiner. The gloves are nitrile, powderfree, ambidextrous, and orange-colored with a beaded cuff. The proposed device is offered in in the following sizes: Small, Medium, Large, Extra-Large, Extra Extra-Large.
The provided document is a 510(k) summary for the Medline Powder-Free Orange Nitrile Patient Examination Gloves (Tested for use with Fentanyl). This document details the performance of a medical device (gloves) against established standards rather than an AI/ML algorithm. Therefore, many of the requested categories for AI/ML studies are not applicable.
However, I can extract information related to the device's acceptance criteria and how its performance was tested.
Acceptance Criteria and Reported Device Performance
The device is evaluated against various ASTM standards. The relevant performance criteria and the reported device performance are presented in the table below:
Table 1: Acceptance Criteria and Reported Device Performance for Medline Powder-Free Orange Nitrile Patient Examination Gloves
| Characteristic | Acceptance Criteria (Standard) | Reported Device Performance | Remarks |
|---|---|---|---|
| Dimensions – Length | ASTM D6319-10: minimal 220mm | Complies with ASTM D6319-10: minimal 220mm | Met criteria |
| Dimensions – Width | ASTM D6319-10: minimal 70mm | Complies with ASTM D6319-10: minimal 70mm | Met criteria |
| Dimensions – Thickness | ASTM D6319-10: minimal Palm – 0.05mm, minimal Finger – 0.05mm | Complies with ASTM D6319-10: minimal Palm – 0.05mm, minimal Finger – 0.05mm | Met criteria |
| Physical Properties (Tensile Strength) | ASTM D6319-10: | ||
| Before Aging ≥14 MPa, | |||
| After Aging ≥14 MPa | Complies with ASTM D6319-10: | ||
| Before Aging ≥14 MPa, | |||
| After Aging ≥14 MPa | Met criteria | ||
| Physical Properties (Elongation) | ASTM D6319-10: | ||
| Before Aging 500% min, | |||
| After Aging 400% min | Complies with ASTM D6319-10: | ||
| Before Aging 500% min, | |||
| After Aging 400% min | Met criteria | ||
| Freedom from Holes | ASTM D6319-10 and ASTM D5151-06: AQL 2.5 | Complies with ASTM D6319-10 and ASTM D5151-06: AQL 2.5 | Met criteria |
| Powder or Powder-Free | Powder-Free (specified by device design) | Powder-Free | Met criteria (design specification) |
| Residual Powder | ASTM D6319-10: 240 minutes for Fentanyl Citrate, 100mcg/2mL | >240 min for Fentanyl Citrate, 100mcg/2mL | Met criteria (note: The predicate device did not have this test, indicating an improvement or additional testing for the subject device) |
| Biocompatibility (Irritation & Sensitization) | ISO 10993-10: Not a skin irritant, Not a skin sensitizer | Not a skin irritant, Not a skin sensitizer | Met criteria |
| Biocompatibility (Cytotoxicity) | ISO 10993-05: Cytotoxic (no specific limit documented beyond passing) | Cytotoxic | Met criteria (test performed, implying acceptable outcome for device classification) |
| Biocompatibility (Systemic Toxicity) | ISO 10993-11: No Acute systemic toxicity | No Acute systemic toxicity | Met criteria |
Since this document is for a physical medical device (patient examination gloves) and not an AI/ML algorithm, the following sections are largely not applicable.
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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)
- N/A. The testing refers to physical sampling of gloves for performance tests (e.g., integrity, strength, fentanyl permeation). Specific sample sizes for each test are not detailed in this summary, but these tests are typically conducted according to the methodology outlined in the cited ASTM and ISO standards. Data provenance (country of origin) is not specified, but the tests were performed in compliance with international and US standards. The testing is prospective (i.e., performed on the manufactured product to demonstrate compliance).
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- N/A. Ground truth for device performance tests (e.g., material strength, hole detection, chemical permeation) is established by empirical measurements and objective criteria defined in the ASTM and ISO standards, not by expert consensus in the diagnostic sense.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- N/A. This concept is for AI/ML algorithm evaluation where multiple readers might interpret data. Device performance testing relies on standardized test methods and objective measurements.
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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
- N/A. This study relates to a physical medical device, not an AI/ML system.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- N/A. This study relates to a physical medical device, not an AI/ML system.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" for the device's performance is based on objective, empirical measurements against defined criteria in recognized standards (e.g., ASTM D6319-10, ASTM D5151-06, ASTM D6978-05, ISO 10993 series). For example, a glove passes the "Freedom from Holes" test if it meets the specified Acceptable Quality Limit (AQL), and fentanyl resistance is determined by measurable breakthrough time. Biocompatibility tests have specific endpoints (e.g., presence/absence of irritation, cytotoxicity).
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The sample size for the training set
- N/A. This device does not involve a training set as it is not an AI/ML algorithm.
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How the ground truth for the training set was established
- N/A. This device does not involve a training set.
§ 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.