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

Subject device: Vinyl Exam Gloves, Powder Free, Clear
Device Class: Class I
Regulation number: 21 CFR 880.6250
Product code: LYZ
Length: 230 mm min
Width: 94 mm min
Palm Thickness: 0.09 mm min
Fingertip Thickness: 0.085 mm min
Tensile Strength (Mpa) Before aging 16.96Mpa average After aging 14.92Mpa average
Ultimate Elongations Before aging 519% average After aging 480% average
Device functions: As a barrier, the subject device prevents contamination between patient and examiner

This document is a 510(k) Premarket Notification from the FDA regarding "Vinyl Exam Gloves, Powder Free, Clear". It's a regulatory submission for a medical device and does not describe an AI/ML powered device or a study related to AI/ML.

Therefore, I cannot provide the requested information about acceptance criteria and studies for an AI device. The document is about physical properties and biocompatibility of examination gloves, not an AI system.

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

White Vinyl Exam Gloves Powder Free is a disposable device intended for medical purposes that is worn upon the examiner's hands or fingers to prevent contamination between patient and examiner. Classified by FDA's General and Plastic Surgery Device panel as Class I. 21 CFR 880.6250, Powder-Free Vinyl Patient Examination Glove. 80LYZ. and meets all requirement of ASTM Standard D5250-06.

The provided document is a 510(k) summary for the "White Vinyl Exam Gloves Powder Free." This is a medical device application for approval based on substantial equivalence to an already marketed predicate device, not a clinical study report for an artificial intelligence or diagnostic device. Therefore, many of the requested elements are not applicable to this type of submission.

However, I can extract the acceptance criteria and performance data as presented for the non-clinical tests conducted to demonstrate substantial equivalence of the proposed device to the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

For this type of device (medical gloves), the "acceptance criteria" are typically defined by recognized standards (like ASTM D5250-06) and the performance of the predicate device. The "device performance" refers to the results obtained from testing the proposed device against these standards and in comparison to the predicate.

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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.

VINYL EXAM GLOVES, POWDER-FREE, YELLOW

The provided text does not contain information about the acceptance criteria or a study proving that a device meets such criteria.

The document is a US FDA 510(k) clearance letter for "Vinyl Exam Gloves, Powder Free, Yellow." It states that the device is substantially equivalent to legally marketed predicate devices. This type of clearance relies on demonstrating substantial equivalence to pre-existing devices, rather than presenting new performance study data against specific acceptance criteria.

Therefore, I cannot provide the requested information based on the given text.

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A PATIENT EXAMINATION GLOVE IS A DISPOSABLE DEVICE INTENDED FOR MEDICAL PURPOSE THAT IS WORN ON THE EXAMINER'S HAND OR FINGER TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.

STERILE DISPOSABLE VINYL SYNTHETIC EXAM GLOVES, POWDER FREE

The provided text is related to an FDA 510(k) clearance for "Sterile Disposable Vinyl Synthetic Examination Gloves, Powder Free". This document is a clearance letter and an "Indications for Use" statement, not a study report or clinical trial summary.

Therefore, the input does not contain the necessary information to describe acceptance criteria and a study that proves the device meets those criteria. The provided text does not describe:

• Acceptance criteria for device performance (e.g., burst strength, tensile strength, barrier integrity).
• Any specific study conducted to test the device's performance against such criteria.
• Sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth establishment.

This document is solely an administrative clearance from the FDA, stating that the device is substantially equivalent to legally marketed predicate devices for its stated indications for use. It does not contain the detailed technical or clinical study information required to answer the prompt.

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This powder-free vinyl exam glove is intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
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.

The device is powder-free vinyl exam gloves. They are non-sterile, single use, disposable gloves.

Here's an analysis of the provided text regarding the acceptance criteria and study for the GLORMED INTERNATIONAL, INC. VINYL EXAMINATION GLOVE, POWDER-FREE:

It's important to note that this document is a 510(k) Summary for a medical glove, which is a relatively low-risk device. The regulatory requirements and the nature of the "study" for such devices are much simpler than for complex AI-powered diagnostic tools. Therefore, many of the requested categories (like MRMC studies, ground truth establishment for training data, number of experts for ground truth, etc.) are not applicable to this type of submission.

Acceptance Criteria and Reported Device Performance

Study Details

Given the nature of the device (a vinyl examination glove), the "study" is a series of laboratory tests to demonstrate compliance with relevant standards and safety requirements.

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

• Sample Size: Not explicitly stated for each test. For physical property tests like water leak, ASTM standards typically specify a sampling plan (e.g., AQL levels). For biocompatibility tests (skin irritation, sensitization), testing is typically done on a representative biological model or a small group of human volunteers.
• Data Provenance: Not specified, but the tests were performed "in a certified testing laboratory." The country of origin of the data is not mentioned, but it's presumed to be from a laboratory that can provide data acceptable to the FDA for a US market submission. The tests are prospective in the sense that they were conducted specifically for this device submission to demonstrate compliance.

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

• Not Applicable. For physical and chemical tests of a medical glove, "ground truth" is established by the objective physical and chemical properties of the glove itself, as measured by standard laboratory procedures. Biocompatibility studies are typically evaluated by toxicologists or dermatologists, but the number of "experts" for ground truth adjudication in the AI sense is not relevant here.

4. Adjudication method for the test set:

• Not Applicable. As per point 3, adjudication in the context of expert consensus for AI is not relevant for these types of lab tests. The tests have pass/fail criteria based on standards.

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:

• Not Applicable. This device is a physical product (medical glove), not an AI-powered diagnostic or assistive tool.

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

• Not Applicable. This is not an algorithm.

7. The type of ground truth used:

• Objective Test Results against Standards. The "ground truth" for the performance claims of the glove is the objective data obtained from the specified laboratory tests (e.g., water leak test, tensile strength implicit in ASTM D5250, results of irritation and sensitization studies) compared against the acceptance criteria defined by the relevant ASTM standards and FDA requirements.

8. The sample size for the training set:

• Not Applicable. This is a physical medical device, not a machine learning model, so there is no "training set."

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

• Not Applicable. As above, no training set for a physical device.

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