Search Results

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

Device Description

VitalCare Powder Free Synthetic Vinyl Examination Glove. A patient examination glove is a disposable device intended for medical purposes that is worn on the hand of healthcare professional and similar personnel to prevent contamination between the healthcare personnel and the patient's body, fluids, waste or environment.

AI/ML Overview

This document details the acceptance criteria for the "VitalCare Powder Free Synthetic Vinyl Examination Glove" and the studies performed to demonstrate its compliance.

1. Table of Acceptance Criteria and Reported Device Performance

Feature/Claim	Acceptance Criteria	Reported Device Performance
Physical and Dimensional Testing	Meets all requirements for ASTM Standard D-5250-00	VitalCare Powder Free Vinyl Examination Glove meets all requirements for ASTM Standard D-5250-00 physical and dimensional testing.
Powder-Free Claim (Starch Content)	No more than 2mg powder per glove (ASTM D6124-01)	VitalCare Powder Free Vinyl Examination Glove meets ASTM D6124-01 for starch to determine the gloves meet the powder-free claim, no more than 2mg powder per glove.
Water Leak Test	FDA 1000ml Water Leak Test	VitalCare Powder Free Vinyl Examination Glove meets FDA 1000ml Water Leak Test.
Primary Skin Irritation	Demonstrates no skin irritation	Primary Skin Irritation tests demonstrate no skin irritation.
Skin Sensitization	Demonstrates no skin sensitization	Skin Sensitization tests demonstrate no skin sensitization.
Intended Use	A disposable device intended for medical purposes that is worn on the hand of healthcare professional and similar personnel to prevent contamination between the healthcare personnel and the patient's body, fluids, waste or environment.	The intended use is clearly stated as: "A patient examination glove is a disposable device intended for medical purposes that is worn on the examiners hand or finger to prevent contamination between the patient and examiner." This aligns with the acceptance criteria.
Materials	Similar to predicate device (Vinyl, Synthetic, Plastic Bag, Corrugated)	The materials used (Vinyl, Synthetic, Plastic Bag, Corrugated) are stated as similar to the predicate device.
Labeling	Similar to predicate device (Reorder Number, Size, Quantity, Non-Sterile, pouch and shipping case, Manufacturer Address) with the addition of "Powder Free" and absence of "Powdered".	Labeling information provided adheres to the required details, specifically mentioning "VitalCare Powder Free Synthetic Vinyl Examination Glove," and other details similar to the predicate device, excluding "Powdered."
Packaging	Similar to predicate device (One plastic bag, 100 pouches per case)	Packaging is stated as "One plastic bag, 100 pouches per case," which is similar to the predicate device.
Sterilization Information	Bulk Non-Sterile	Device is described as "Bulk Non-Sterile."
Comparative Claims	No comparative claims (e.g., hypoallergenic, comparison to other devices)	"No comparative claims are made for the VitalCare Powder Free Synthetic Vinyl Examination glove. The glove is not claimed as hypoallergenic. It will not be compared in labeling or advertising to other devices."
Unique Designs	Not unique	"The design of the VitalCare Powder Free Vinyl Examination Glove is not unique."

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

The document does not explicitly state the sample sizes used for each specific test (e.g., physical, dimensional, water leak, skin irritation, skin sensitization). It only refers to the tests performed to meet the standards. The data provenance (country of origin of the data, retrospective or prospective) is not specified.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

The document does not mention the number of experts or their qualifications for establishing ground truth for any of the performance tests. The "ground truth" for these tests is defined by the objective metrics and standards themselves (e.g., ASTM D-5250-00, ASTM D-6124-01, FDA 1000ml Water Leak Test, and standard dermatological tests for irritation/sensitization).

4. Adjudication Method for the Test Set

No adjudication method is described. The performance data seems to be based on direct measurement and adherence to established standard specifications rather than subjective expert review requiring adjudication.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not performed. The device is an examination glove, and its performance is evaluated against physical and chemical standards, not through human reader diagnostic accuracy.

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

Yes, the performance tests described (ASTM standards, FDA water leak test, skin irritation/sensitization) are inherently standalone evaluations of the device's physical and biological properties. They do not involve human-in-the-loop performance in the way an AI diagnostic algorithm would.

7. The Type of Ground Truth Used

The ground truth used for performance evaluation is based on objective standards and test methods:

ASTM Standard D-5250-00: For physical and dimensional testing.
ASTM D-6124-01: For starch content to quantitatively determine the "powder-free" claim.
FDA 1000ml Water Leak Test: For assessing barrier integrity.
Primary Skin Irritation and Skin Sensitization tests: Standard toxicological/dermatological testing to assess biocompatibility.

8. The Sample Size for the Training Set

This information is not applicable. The device is a physical product (an examination glove), not an AI algorithm requiring a "training set."

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

This information is not applicable for the same reason as point 8.

Ask a Question

Ask a specific question about this device

Page 1 of 1