Search Results

A 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.

Powder Free Nitrile Examination Glove meets all the current specifications listed under the ASTM Specification D6319-10. Standard Specification for Nitrile Examination Gloves for Medical Application. 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 document is a 510(k) Premarket Notification for Powder Free Nitrile Examination Gloves (K210369) by Pastel Glove Sdn Bhd. It compares the proposed device to a predicate device (K153562) to demonstrate substantial equivalence.

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

1. A table of acceptance criteria and the reported device performance:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

The document does not explicitly state the exact sample sizes used for each test. However, it references standards that imply specific sampling methodologies:

• ISO 2859-1:1999, "Sampling Procedures for Inspection by Attributes Part I: Sampling Plans Indexed by Acceptable Quality Level (AQL) for Lot-by-Lot Inspection." This standard specifies sampling plans for lot-by-lot inspection based on Acceptable Quality Level (AQL). For "Freedom of Holes," the acceptance criterion is AQL 2.5 at G1, and the device met AQL 1.5 at G1, implying that the sampling was done in accordance with this standard.
• ASTM D6319-10, Standard Specification for Nitrile Examination Gloves for Medical Application. This standard would also dictate sampling sizes and methods for physical property tests.
• ASTM D5151-06, Standard Test Method for Detection of Holes in Medical Gloves.
• ASTM D6124-06, Standard Test Method for Residual Powder on Medical Gloves.
• ISO 10993-10:2010 Biological Evaluation of Medical Devices Part 10: Tests For Irritation And Skin Sensitization.
• ISO 10993-11:2017 Biological evaluation of medical devices Part 11: Tests for systemic toxicity.

The data provenance is not explicitly stated in terms of country of origin but is likely generated by the manufacturer or a contracted lab to meet the specified standards. The tests appear to be prospective, performed specifically for this 510(k) submission to demonstrate compliance.

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 as the device is a medical glove, and the "ground truth" for its performance is established through objective physical, chemical, and biological testing according to established ASTM and ISO standards, not through expert consensus or interpretation of images.

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

This information is not applicable for the type of device and testing described. Adjudication methods like 2+1 or 3+1 are typical for subjective assessments, often in imaging or clinical scenarios where multiple experts might disagree on an interpretation. The tests for gloves (e.g., tensile strength, hole detection, chemical residue) are objective and measured against predefined criteria.

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 information is not applicable. An MRMC study is relevant for devices involving human interpretation, often aided by AI, especially in diagnostic imaging. This submission concerns a physical medical device (examination glove) and its inherent performance characteristics.

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

This information is not applicable. The device is a physical glove, not an algorithm or software. Therefore, there is no "algorithm only" performance to evaluate.

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

The "ground truth" for the performance of these gloves is defined by:

• Established ASTM and ISO standards: These standards specify the acceptable ranges and methodologies for physical properties (e.g., thickness, tensile strength, elongation), barrier integrity (holes), and biocompatibility (skin irritation, sensitization, systemic toxicity).
• Objective measurements: The tests involve quantifiable measurements (e.g., mm for length/width/thickness, MPa for tensile strength, % for elongation, mg/glove for powder residue).
• Pass/fail criteria: Biocompatibility tests determine whether the device causes irritation, sensitization, or systemic toxicity under specific study conditions.

8. The sample size for the training set:

This information is not applicable. This is a physical medical device (examination glove), not an AI/ML algorithm that requires a "training set."

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

This information is not applicable as there is no "training set" for this type of device submission.

Ask a specific question about this device