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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 or finger to prevent contamination between patient and examiner. It is for over-the-counter use.

Pink Nitrile Examination Glove. Powder Free. as described in this 510(k) Notification is substantially equivalent to the current class I patient examination gloves with product Code LZA (21CFR 880.6250). It meets all the specifications in ASTM D6319-10, Standard specification for Nitrile Examination Gloves. They are made nitrile from nitrile latex compound, Pink color, Powder free and non sterile.

This document is a 510(k) Pre-market Notification for a medical device: "EMG Pink Nitrile Examination Glove Powder Free." The primary goal of the submission is to demonstrate that the new device is substantially equivalent to a legally marketed predicate device (K141590, EMG Blue Nitrile Medical Examination Glove Powder Free).

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

1. Table of acceptance criteria and the reported device performance:

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

• The document does not explicitly state the sample sizes for the tests conducted to demonstrate compliance with ASTM D6319-10, ASTM D5151-06, ASTM D6124-06, or the biological evaluation tests (skin irritation and dermal sensitization). These standards specify sampling plans, but the specific number of units tested is not reported in this summary.
• Data Provenance: The submitting company, ECO MEDI GLOVE SDN. BHD., is located in Malaysia. Therefore, the data likely originates from testing conducted there, or by third-party labs often contracted by manufacturers for such compliance testing. The document states a "Preparation Date" of 20th July 2016, indicating the tests were conducted prior to this date. The data is retrospective relative to the submission date.

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

• This information is not provided in the document. The tests performed (e.g., physical properties, pinhole, residual powder, biological evaluation) are standardized laboratory tests. The "ground truth" for these tests is defined by the methodology of the ASTM standards and biological evaluation protocols themselves, rather than by expert consensus on interpretations of images or findings. While qualified laboratory personnel perform these tests, their specific "expert" qualifications (e.g., years of experience) or number are not detailed.

4. Adjudication method for the test set:

• Not applicable as the tests are objective, standardized laboratory measurements and assessments according to specific ASTM standards (D6319-10, D5151-06, D6124-06) and biological evaluation protocols. These types of tests typically do not involve multiple expert readers and subsequent adjudication in the way medical imaging interpretation might.

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 pertains to the 510(k) clearance of a patient examination glove, which is a physical medical device. It does not involve AI software or human readers interpreting medical cases. No MRMC study was performed.

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

• Not applicable. This is a physical medical device (glove), not an algorithm or AI software. No standalone algorithm performance was assessed.

7. The type of ground truth used:

• The "ground truth" is established by adherence to recognized international and national standards for examination gloves:
  • ASTM D 6319-10: Standard Specification for Nitrile Examination Gloves for Quality Assurance, Dimensional, and Physical Property (Tensile Strength, Ultimate Elongation) testing.
  • ASTM D5151-06: Standard Test Method for Detection of Holes in Medical Gloves for Pin-hole Level.
  • ASTM D6124-06: Standard Test Method for Residual Powder on Medical Gloves for Residual Powder.
  • Biological Evaluation on Medical Device - Primary Skin Irritation Test: Assesses skin irritation potential.
  • Biological Evaluation on Medical Device - Dermal Sensitization Assay: Assesses the potential for allergic sensitization.
• These standards and biological tests define the objective criteria and methodologies against which the device's performance is measured.

8. The sample size for the training set:

• Not applicable. This product is a physical device, not an AI/ML algorithm that requires a training set. The data presented are for performance testing of the final product.

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

• Not applicable, as there is no training set for this device.

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