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A powder-free 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. The glove was tested for use with Chemotherapy Drugs and Fentanyl Citrate as per ASTM D6978-05 Standard Practice for Assessment for Medical Gloves to Permeation by Chemotherapy Drugs.

The Sapphire Pro Powder-Free Royal Blue Nitrile Exam Gloves 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, powder-free, ambidextrous, and blue-colored with a beaded cuff. The range of sizes includes small, medium, large, and extra-large.

The provided document is a 510(k) summary for the Sapphire Pro Powder-Free Royal Blue Nitrile Exam Gloves, detailing their substantial equivalence to a predicate device. It includes information on acceptance criteria and performance for various tests relevant to examination gloves, particularly concerning permeation by chemotherapy drugs and fentanyl.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based solely on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document provides a "Summary of Nonclinical Testing" table. This section outlines the tests performed, their purpose, acceptance criteria, and the results for the Sapphire Pro Powder-Free Royal Blue Nitrile Exam Gloves.

Detailed Chemotherapy Drug Permeation Results (from "Indications for Use" section):

Note on Cytotoxicity: The device failed the cytotoxicity test ("Fail – Under the conditions of the study, the subject device is cytotoxic."). However, the conclusion states that the device is "as safe, as effective, and performs as well as or better than the legally marketed predicate device." The comparative table indicates the predicate device was also "cytotoxic," suggesting this is an anticipated characteristic for this type of nitrile glove and not a disqualifying factor for substantial equivalence in this context.

2. Sample size used for the test set and the data provenance

The document specifies the tests conducted according to various ASTM and ISO standards for medical gloves. While the standards imply established testing methodologies and sample sizes (e.g., AQL 2.5 for hole detection typically involves specific sample sizes), the exact numerical sample sizes used for each specific test (e.g., for biocompatibility, physical properties, or permeation tests) are not explicitly stated in this summary.

Data provenance: The tests were conducted according to internationally recognized standards (ASTM, ISO). The document does not specify the country of origin of the data collectors or if the data was retrospective or prospective. It is implied to be prospective testing carried out for the device's clearance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This section is not applicable to this document. The "ground truth" for medical gloves like these is established through standardized laboratory testing procedures (e.g., ASTM D6978-05 for permeation, ASTM D6319-19 for physical dimensions, ISO 10993 series for biocompatibility). There are no human "experts" establishing a "ground truth" for classification or diagnosis in the way one would for an AI CAD system for medical imaging. The performance is measured against objective, measurable criteria defined by the standards.

4. Adjudication method for the test set

This concept is not applicable as the "test set" involves objective performance testing against established standards, not subjective expert reviews or diagnostic interpretations.

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

This concept is not applicable as the device is a medical glove, not an AI-assisted diagnostic tool requiring human reader studies.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This concept is not applicable as the device is a medical glove, not an AI algorithm. Its performance is inherent to its physical and chemical properties.

7. The type of ground truth used

The "ground truth" for the performance claims of these gloves is based on standardized laboratory test results defined by the relevant ASTM (American Society for Testing and Materials) and ISO (International Organization for Standardization) standards. These include:

• Physical measurements (e.g., length, width, thickness).
• Mechanical properties (e.g., tensile strength, elongation).
• Barrier integrity (e.g., freedom from holes).
• Chemical resistance (e.g., breakthrough time for drugs).
• Biocompatibility (e.g., irritation, sensitization, cytotoxicity, systemic toxicity).

8. The sample size for the training set

This concept is not applicable as the device is a medical glove, not a machine learning model that requires a training set.

9. How the ground truth for the training set was established

This concept is not applicable as the device is a medical glove, not a machine learning model.

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