Search Results

A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

Powdered Latex Patient Examination Glove with Protein Content Labeling Claim (Contains 200 Micrograms per dm2 of glove or Less of Water Extractable Protein) meets all the current specification for ASTM D3578-05 (2010).

Acceptance Criteria and Device Performance Study for K120693 - Powdered Latex Patient Examination Glove

This document describes the acceptance criteria and the study demonstrating that the "Powdered Latex Patient Examination Glove with Protein Content Labeling Claim (Contains 200 Micrograms per dm² of glove or Less of Water Extractable Protein)" (K120693) meets these criteria.

1. Table of Acceptance Criteria and Reported Device Performance

The device's performance was evaluated against established ASTM standards and ISO standards for biocompatibility.

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

The document does not explicitly state the sample sizes used for each specific test or the country of origin for the data. However, the evaluation relies on compliance with established ASTM and ISO standards, which typically involve specific sampling plans and test methods. The studies are non-clinical performance tests.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. For this type of medical device (patient examination gloves), the "ground truth" is established by adherence to recognized national and international consensus standards (ASTM and ISO), not by expert consensus on clinical data or image interpretation. The tests are laboratory-based and objective measurements.

4. Adjudication Method for the Test Set

Not applicable. The performance testing involves objective measurements against established standard specifications, not subjective interpretation requiring adjudication among experts.

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

Not applicable. This device is a patient examination glove, and its performance is assessed through non-clinical laboratory testing against physical, chemical, and biocompatibility standards. MRMC studies are typically relevant for diagnostic imaging or similar devices that involve human interpretation of results.

6. Standalone Performance Study

Yes, a standalone (algorithm only without human-in-the-loop performance) study was done in the sense that the device itself, a physical product, was subjected to a series of laboratory tests to evaluate its inherent characteristics against the specified standards. Human interaction is limited to conducting the tests according to the standard protocols and recording the objective results.

7. Type of Ground Truth Used

The ground truth used is based on established national and international consensus standards (ASTM and ISO). These standards define objective pass/fail criteria and test methodologies for dimensions, physical properties, freedom from pinholes, powder amount, protein content, and biocompatibility.

8. Sample Size for the Training Set

Not applicable. This device is a physical product, not an algorithm or AI model that requires a training set. The evaluation is based on direct testing of the manufactured product batches against standardized criteria.

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

Not applicable, as there is no "training set" for this device. The ground truth for evaluating the device's performance is established by the specified ASTM and ISO standards themselves, which outline the acceptable ranges and test methods.

Ask a specific question about this device

Latex Examination Glove is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient.

Latex Examination Gloves (Powdered)

The provided document is a 510(k) clearance letter from the FDA for "Latex Examination Gloves (Powdered)". This type of document is a regulatory approval for a medical device and does not contain the detailed technical study information that would describe acceptance criteria and device performance in the way requested for AI/ML or diagnostic devices.

Therefore, I cannot extract the information requested regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, or MRMC studies, as these types of studies are not typically conducted or reported in a 510(k) summary for general-purpose physical devices like examination gloves. The 510(k) pathway for such devices primarily focuses on demonstrating substantial equivalence to a predicate device, often through engineering specifications, material properties, and basic performance tests (e.g., integrity, strength), rather than clinical performance metrics that would involve complex statistical analyses and expert adjudication.

Ask a specific question about this device