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The Powder Free Latex Examination Glove is a disposable device made of natural rubber latex that may bear a trace amount of glove powder and is intended to be worn on hands or finger(s) for medical purposes to provide a barrier.against potentially infectious materials and other contaminants.

The Powder Free Latex Examination Gloves. Natural or Blue Colour and with Protein Content Labeling Claim is equivalent to the exiting model, i.e. Latex Patient Examination Gloves. Powder Free which had submitted and cleared under 510(k) number K924356.

The differences in this submission are:

• With or without colour additive upon customers` preference or request. a)
• With protein content labeling claim, i.e. "This latex glove contains 50 micrograms or b) less of total water extractable protein per gram``.

The provided document is a 510(k) summary for a medical device: "Powder Free Latex Examination Gloves, Natural or Blue Colour and with Protein Content Labeling Claim (50 Micrograms or Less)". This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving the safety and effectiveness of a novel device through extensive clinical trials. Therefore, many of the typical clinical study criteria (like sample size for test set, number of experts, adjudication methods, MRMC studies, standalone AI performance, and training set information) are not applicable or not detailed in this type of regulatory filing.

The acceptance criteria are primarily based on established ASTM standards and FDA regulations for patient examination gloves. The "study" proving the device meets these criteria is a series of tests against these standards.

Here's a breakdown based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Pinhole Freedom: 125 gloves were tested.
• Sample Size for Visual Inspection: 125 gloves for both major and minor defects.
• Sample Size for Powder Residual: Not explicitly stated, but an average value (Avg. 0.96 mg/glove) is given, implying multiple samples were measured.
• Sample Size for Protein Content: Not explicitly stated, but a range (17 - 29 µg/g) is given, implying multiple samples were measured.
• Sample Size for Physical Properties (e.g., dimensions, tensile strength): Not explicitly stated, but averages or ranges are provided, indicative of testing on multiple units.
• Data Provenance: The document implies testing was conducted by the manufacturer, Medipure Corporation (M) Sdn Bhd, located in Malaysia. The testing is laboratory-based performance testing, not human clinical trial data. It is inherently retrospective in the sense that these are tests performed on manufactured product batches.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• This information is not applicable as the device is a physical product (examination gloves) tested against predefined technical standards and physical properties, not an AI or diagnostic device requiring expert interpretation for ground truth.

4. Adjudication Method for the Test Set

• This information is not applicable. The assessment involves objective physical and chemical tests against quantitative standards (e.g., palm width in mm, tensile strength in MPa, protein content in µg/g). There is no "adjudication" in the sense of reconciling differing expert opinions.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

• No, a MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic or AI-assisted interpretation devices where multiple human readers' performance with and without AI assistance is evaluated. This device is a medical glove, and such a study is irrelevant to its function or regulatory clearance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done

• Not applicable. This device is a physical product (gloves), not an algorithm or AI system.

7. The Type of Ground Truth Used

• The "ground truth" for this device's performance is established by objective, standardized laboratory measurements and tests. These tests align with the specifications outlined in:
  • ASTM D 3578 (Standard Specification for Latex Examination Gloves)
  • ASTM D 6124 (Standard Test Method for Residual Powder on Medical Gloves)
  • ASTM D 5712 (Standard Test Method for Analysis of Aqueous Extractable Protein in Latex and Natural Rubber)
  • FDA 21 CFR 800.20 (Medical devices; effectiveness in preventing pinholes in rubber prophylactics and gloves)
  • 16 CFR Part 1500 (Federal Hazardous Substances Act regulations, regarding primary skin irritation)
  • Buehler Method (for dermal sensitization)
  • In-House Specifications (for visual inspection of major and minor defects).

8. The Sample Size for the Training Set

• Not applicable. This device is a physical product, not an AI or machine learning model that requires a "training set."

9. How the Ground Truth for the Training Set Was Established

• Not applicable. As stated above, this device does not utilize a training set. The "ground truth" for the device's manufacturing and quality control is established by adherence to the standardized tests mentioned in point 7.

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