Search Results

Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) 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.

Powder-Free Vinyl Patient Examination Gloves, Clear (Non-colored) that meets all of the requirements of ASTM standard D 5250-06(Reaffirmation 2011).
-- How the device functions:
PVC films form a barrier to body fluids and bloodborne Pathogens
-- Scientific concepts that form the basis for the device
The PVC 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.
-- Physical and performance characteristics such as design, materials and physical properties:
PVC gloves are 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 D5250 and ASTM D5151 requirements.

The document describes the acceptance criteria and performance of the "Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)" manufactured by Better Plastic Co., Ltd. against regulatory standards and a predicate device.

Table of Acceptance Criteria and Reported Device Performance

Study Details:

The document describes a submission for a 510(k) premarket notification, which is a process to demonstrate that the new device is substantially equivalent to a legally marketed predicate device. The study is a comparison of the subject device's performance against established ASTM standards and the predicate device's characteristics rather than a traditional clinical study with patients.

1. Sample sizes used for the test set and the data provenance:

   • The document does not specify a distinct "test set" in the context of a clinical trial or algorithm evaluation. Instead, the "testing" refers to the manufacturing quality control and performance evaluation of the gloves based on established ASTM standards.
   • The data provenance is from non-clinical testing performed by the manufacturer, Better Plastic Co., Ltd. The country of origin for the manufacturing and testing is China, as indicated by the submitter's address. The data is prospective in the sense that it's generated for the submission of this specific device.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • This question is not applicable to this type of device and submission. "Ground truth" in the context of diagnostic AI or image analysis typically refers to definitively confirmed diagnoses by expert clinicians, pathology, or long-term outcomes. For patient examination gloves, the "truth" is whether they meet specified physical, chemical, and biological performance standards (e.g., tensile strength, freedom from pinholes, biocompatibility). These are evaluated through standardized laboratory tests, not by human expert consensus on a diagnostic outcome.

3. Adjudication method for the test set:

   • Not applicable. The "adjudication" for this product involves laboratory testing against defined standards. There is no human observer consensus or adjudication required beyond verifying that the test results meet the specified criteria.

4. 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:

   • Not applicable. This is a medical device (patient examination gloves), not an AI diagnostic imaging tool or a system that involves human "readers" or AI assistance.

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

   • Not applicable. This device is not an algorithm or AI system. Its performance is evaluated through physical and chemical testing.

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

   • The "ground truth" for this device's performance is defined by adherence to established international and national standards for patient examination gloves, specifically:
     • ASTM D5250-06 (Reaffirmation 2011): Standard Specification for Poly(Vinyl Chloride) Gloves for Medical Application.
     • ASTM D5151-06 (Reapproved 2011): Standard Test Method for Detection of Holes in Medical Gloves.
     • ASTM D6124-06 (Reaffirmation 2011): Standard Test Method for Residual Powder on Medical Gloves.
     • 21 CFR 800.20: General requirements for medical devices.
     • ISO 10993-10 Third Edition 2010-08-01: Biological evaluation of medical devices -- Part 10: Tests for irritation and skin sensitization.
   • The testing also focuses on demonstrating substantial equivalence to a legally marketed predicate device (K120968) which presumably met these same standards.

7. The sample size for the training set:

   • Not applicable. There is no "training set" in the context of this device. The manufacturing process is controlled, and samples are taken for quality assurance testing against the standards. This is not an AI/ML product that learns from a training dataset.

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

   • Not applicable, as there is no training set for this type of device. The performance standards are established by consensus national and international bodies (e.g., ASTM, ISO, FDA regulations) for medical devices of this type.

Ask a specific question about this device