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This is a medical glove to be worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient.

Class I Nitrile patient examination gloves 80LZA, powder free and meeting all the requirements of the ASTM Draft Standard Specification for Nitrile Examination Gloves for Medical Application.

Here's a breakdown of the acceptance criteria and study information for the ROYAL SHIELD™ POWDER FREE COLORED NITRILE EXAMINATION GLOVES, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size (Water Tight Test): 80 pieces per batch (total of 240 pieces across Small, Medium, and Large sizes for batch 9705261002).
• Sample Size (Other Tests): Not explicitly stated for each test, but it is implied that samples from the production of "ROYAL SHIELD" gloves were used for all listed tests.
• Data Provenance: The manufacturing company is Shield Gloves Manufacturer (M) Sdn. Bhd. located in Malaysia. The data is thus likely derived from their testing processes, which would be retrospective in nature for this submission, as they are reporting on already manufactured and tested products.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

• None stated. The "ground truth" for the performance tests relies on established ASTM standards and FDA internal requirements for medical device testing, not expert consensus on specific cases. For example, a "Pass" on a Dermal Irritation Test is based on standardized experimental protocols, not an expert's subjective judgment.

4. Adjudication Method for the Test Set

• None stated. Due to the nature of the device (examination gloves) and the type of performance testing (physical properties, leak tests, biocompatibility), adjudication by multiple experts is not applicable. The results are quantitative measurements or pass/fail outcomes based on standardized protocols.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No. This type of study (MRMC) is relevant for diagnostic or interpretive devices where human readers evaluate cases, often with and without AI assistance, to assess the AI's impact on reader performance. This device is an examination glove, which does not involve human interpretation of cases or images.

6. Standalone Performance Study

• Yes, implicitly. All the reported tests (dimension, physical properties, water leak, biocompatibility, powder content) reflect the standalone performance of the glove itself, without any human-in-the-loop interaction beyond handling for the test procedure. The data directly quantifies the device's characteristics against predefined standards.

7. Type of Ground Truth Used

• The "ground truth" used for evaluating the device's performance is based on established industry standards and regulatory requirements:
  • ASTM D3578-95 (Standard Specification for Rubber Examination Gloves)
  • ASTM Draft Standard Specification for Nitrile Examination Gloves for Medical Application
  • FDA specified 1,000 ml water leak test requirements
  • FDA biocompatibility requirements
  • FDA Internal Requirement for residual powder content
  • ASTM D 5151-90 Test Method for Detection of Holes in Medical Gloves (mentioned in conclusion)

8. Sample Size for the Training Set

• Not applicable. This device is a physical product (medical glove) and not an AI/machine learning algorithm that requires a "training set" of data. The manufacturing process is controlled to produce gloves that meet specifications.

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

• Not applicable. As a physical product, there is no "training set" or corresponding ground truth establishment in the context of machine learning. The "ground truth" for manufacturing quality control would be the adherence to the ASTM standards and FDA requirements listed in point 7.

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