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A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. This glove is also tested for use against Chemotherapy Drugs. The Chemotherapy Drugs and its permeation time is listed as below.

Non-Sterile, Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs - Blue and Non-Sterile, Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs - Cobalt Blue meets all the current specifications listed under the ASTM Specification D6319-10, Standard Specification for Nitrile Examination Gloves for Medical Application and D6978-05 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs and FDA 21 CFR 880.6250. The principle operation and mechanism of this device is to prevent contamination between patient and examiner and this principle is achieved through testing of barrier, physical properties and other testing stated in the performance data. This device is for over-the counter single use.

The provided text describes the acceptance criteria and performance data for two types of nitrile examination gloves: "Non-Sterile, Powder Free Nitrile Examination Gloves, Tested for use with Chemotherapy Drugs (Blue)" and "Non-Sterile, Powder Free Nitrile Examination Gloves, Tested for use with Chemotherapy Drugs (Cobalt Blue)". The information is presented as a 510(k) summary, comparing the subject devices to a predicate device (K161215).

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

The acceptance criteria for the gloves are primarily based on ASTM standards (ASTM D6319-10 for physical and dimensional properties, ASTM D6124-06 for powder-free claims, and ASTM D6978-05 for chemotherapy drug permeation), as well as ISO 10993-10 for biocompatibility. The reported device performance is compared against these standards and the predicate device.

Warning Statements related to acceptance/use:

• Blue Glove: "WARNING: Please note that the following drugs have extremely low permeation times: Carmustine: 15.0 minutes and ThioTepa: 30.1 minutes. NOT TO BE USED WITH CARMUSTINE OR THIOTEPA."
• Cobalt Blue Glove: "WARNING: Please note that the following drugs have extremely low permeation times: Carmustine: 2.4 minutes and ThioTepa: 1.9 minutes. NOT TO BE USED WITH CARMUSTINE OR THIOTEPA."

Study Proving Device Meets Acceptance Criteria:

The device's performance is demonstrated through testing against recognized standards. The document is a 510(k) summary for premarket notification, which means the manufacturer conducted tests to show substantial equivalence to a legally marketed predicate device.

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

• Sample Size: The document does not explicitly state the sample sizes used for each specific test (e.g., number of gloves tested for permeation, water tightness, or biocompatibility). The testing is generally indicated as "Meets" specific ASTM/ISO standards, which typically prescribe minimum sample sizes for conformity testing.
• Data Provenance: The tests were conducted to support a premarket notification for devices manufactured by YTY Industry (Manjung) Sdn Bhd in Malaysia. This suggests the data originates from tests conducted by or for the manufacturer, likely in an accredited lab to demonstrate compliance with the referenced international standards. The data is retrospective in the context of this 510(k) submission, meaning the tests were performed prior to the submission to demonstrate device characteristics.

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

This information is not applicable to this type of device and study. The "ground truth" for glove performance testing (e.g., permeation time, physical properties) is established through standardized laboratory methods and instrument readings, not expert consensus or interpretation of images.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

This is not applicable as the determination of device characteristics (e.g., breakthrough time, physical dimensions) is based on objective measurements and standardized test protocols, not on human expert adjudication.

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 is not applicable. This document describes performance testing for medical gloves, not an AI-powered diagnostic or interpretive device. Therefore, no MRMC study, human readers, or AI assistance is involved.

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

This is not applicable as the device is a medical glove, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The "ground truth" for the performance claims of these gloves is based on:

• Standardized Test Methods: Adherence to established international standards like ASTM D6319-10, ASTM D6978-05, ASTM D6124-06, and ISO 10993-10.
• Objective Measurements: Laboratory measurements of physical properties (e.g., dimensions, thickness, water leakage, powder content) and chemical permeation breakthrough times using specified equipment and protocols.

8. The sample size for the training set:

This is not applicable. The device is a manufactured good (gloves), not an AI model requiring a training set.

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

This is not applicable as there is no training set for this device.

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