Search Results

Nitrile Powder Free Patient Examination Gloves, Blue Color is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Nitrile films form a barrier to body fluids and bloodborne Pathogens. The nitrile rubber is water tight under normal conditions of use. Its tensile properties cause it to conform to the hand, allowing movements necessary for a medical procedure. Nitrile glove is known to create a barrier to bloodborne pathogens and body fluids. ASTM conforming tensile properties create a glove that is strong and flexible. The glove is manufactured in accordance with the requirements of ASTM D6319 and ASTM D5151 requirements.

The document describes the acceptance criteria and performance data for the "Nitrile Powder Free Patient Examination Gloves, Blue Color." The information is presented in the context of a 510(k) premarket notification, where the device's substantial equivalence to a predicate device is demonstrated through non-clinical performance testing.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: The document does not explicitly state the specific numerical sample sizes for each test (e.g., number of gloves tested for dimensions, pinholes, etc.). It refers to meeting general ASTM standards and regulations (e.g., AQL 2.5 for pinholes), which inherently define sampling plans.
• Data Provenance: The tests for physical properties, dimensions, pinholes, and powder residual appear to be based on product testing conducted by the manufacturer, Huikang Glove Co., Ltd., which is located in China. The biocompatibility tests (Primary Skin Irritation and Dermal Sensitization) were performed according to ISO 10993-10 standards. The studies are retrospective as they summarize data already collected.

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 patient examination gloves is established by objective, standardized physical and chemical testing methods dictated by ASTM and ISO standards, not expert consensus on medical image interpretation or diagnosis.

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

• None. Adjudication methods like 2+1 or 3+1 are typically used in studies where human interpretation of data (e.g., medical images) is involved and discrepancies need to be resolved. For the physical and chemical testing of gloves, the results are quantitative and objective, determined by laboratory instruments and methods.

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:

• No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI/CAD systems that assist human interpretation in diagnostic tasks. The device in question is a medical glove, for which such a study is entirely inappropriate.

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

• Not applicable. This device is a physical product (a medical glove), not a software algorithm. Therefore, there is no "standalone" algorithm performance to evaluate.

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

• The "ground truth" for this device is based on objective measurements against established industry standards and regulatory requirements. This includes:
  • Physical measurements: Adherence to specified dimensions (length, width, thickness).
  • Material properties: Tensile strength and elongation, as defined by ASTM D6319-10.
  • Barrier integrity: Freedom from pinholes, assessed by waterleak tests (21 CFR 800.20, ASTM D5151-06).
  • Chemical properties: Powder residual levels (ASTM D6124-06).
  • Biocompatibility: Results from standardized irritation and sensitization tests (ISO 10993-10).

8. The sample size for the training set:

• Not applicable. This device is a physical product, not an AI model requiring a training set. The manufacturing process is subject to quality control and adherence to standards, but there is no "training set" in the context of machine learning.

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

• Not applicable. As there is no training set for this device, a method for establishing its ground truth is irrelevant.

Ask a specific question about this device