Search Results

Powder Free Nitrile Patient Examination Gloves, Black 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. It's 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 provided document is a 510(k) summary for "Powder Free Nitrile Patient Examination Gloves, Black Color". It details the device's characteristics and compares it to a predicate device to establish substantial equivalence.

Here's the information about the acceptance criteria and the study that proves the device meets them:

1. A 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 specify the exact sample size used for each test. It refers to compliance with ASTM standards, which would implicitly define sample sizes for those tests.

The data provenance is from China as the submitter, Suqian Xingye Glove Co, Ltd, is located in Suqian City, Jiangsu Province, China. The studies are retrospective, as they involve testing of a manufactured device according to established standards.

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 "ground truth" for these types of devices is objective measurement against specified standards, rather than expert interpretation. For biocompatibility, it's typically conducted by trained laboratory personnel following standard protocols.

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

Adjudication methods such as 2+1 or 3+1 are typically used in clinical studies involving human interpretation or subjective assessment. This document describes objective performance testing against established ASTM and ISO standards for physical properties, barrier integrity, and chemical content. Therefore, no adjudication method as described would be applicable or necessary. The standard itself defines the pass/fail 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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices involving human interpretation, especially with AI assistance. The device in question is a patient examination glove, and its effectiveness is determined by its physical and chemical properties, not by human reader performance or AI collaboration.

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

This question is not applicable to the device. The device is a physical medical glove, not an algorithm or software. Its performance is evaluated through physical and chemical laboratory testing as described by the standards.

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

The "ground truth" for the test set is established by objective, quantitative standards and specified test procedures defined by:

• ASTM standard D 6319-10 (for Dimension and Physical Properties)
• 21 CFR 800.20 and ASTM D 5151-06 (Reapproved 2011) (for Freedom from Pinholes)
• ASTM standard D 6319-10 and D6124-06 (Reapproved 2011) (for Powder Residual)
• ISO 10993-10: Third Edition 2010-08-01 (for Biocompatibility – Primary Skin Irritation and Dermal Sensitization)

These standards specify the methodology and acceptance limits for each characteristic.

8. The sample size for the training set

This information is not applicable. The device is a medical glove, not an AI or machine learning model that requires a training set. The manufacturing process for gloves is subject to quality control and process validation, not a "training set" in the context of data-driven systems.

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

This information is not applicable, as there is no "training set" for this device.

Ask a specific question about this device