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

Device Description

The subject device is powder free vinyl synthetic patient examination gloves. The subject device is blue. The design of subject device is addressing the standards as ASTM D6124, ASTM D5151, and ASTM D5250. The subject device is non-sterile.

AI/ML Overview

The provided document is a 510(k) summary for a medical device: "Disposable Vinyl Nitrile Synthetic Gloves Powder Free". This document describes the device's characteristics, its comparison to a predicate device, and the results of non-clinical tests conducted to demonstrate its safety and effectiveness.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Test Methodology	Purpose	Acceptance Criteria	Reported Device Performance
ASTM D5250	Physical Dimensions Test	Length (mm): ≥230 Width (mm): S: 85±5; M: 95±5; L: 105±5; XL: 115±5 Thickness (mm): Finger: ≥0.05, Palm: ≥0.05	Length: >230 Width: S: 84-89; M: 93-97; L: 105-107; XL: 115-116 Finger Thickness: 0.08-0.2 Palm Thickness: 0.07-0.08 Result: Pass
ASTM D5151	Watertightness Test for Detection of Holes	Meet the requirements of ASTM D5151 AQL 2.5	0/125 leaks Result: Pass
ASTM D6124	Powder Content	Meet the requirements of ASTM D6124 < 2.0mg	0.07 mg Result: Pass
ASTM D412	Physical Properties - Before Aging	Tensile Strength: ≥11MPa Ultimate Elongation: ≥300%	Tensile Strength: 11.6-16.2 Ultimate Elongation: 308-391 Result: Pass
ASTM D412	Physical Properties - After Aging	Tensile Strength: ≥11MPa Ultimate Elongation: ≥300%	Tensile Strength: 11.0-14.0 Ultimate Elongation: 323-337 Result: Pass
ISO 10993-5	Cytotoxicity	Non-cytotoxic	Under conditions of the study, did not show potential toxicity to L-929 cells. Result: Pass
ISO 10993-10	Irritation	Non-irritating	Under the conditions of the study, not an irritant. Result: Pass
ISO 10993-10	Sensitization	Non-sensitizing	Under conditions of the study, not a sensitizer. Result: Pass

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

ASTM D5151 (Watertightness): The test result states "0/125 leaks", indicating a sample size of 125 gloves for this particular test.
Other tests (ASTM D5250, ASTM D6124, ASTM D412, ISO 10993-5, ISO 10993-10): The specific sample sizes for these tests are not explicitly stated in the provided summary. However, these are generally performed on a sufficient number of samples to meet the requirements of the respective ISO/ASTM standards.
Data Provenance: The device manufacturer (Tangshan Hongyun Healthcare Products Co., Ltd.) is located in China. The non-clinical tests were conducted to verify the device met design specifications. The document does not specify if the data is retrospective or prospective, but given the nature of product testing for regulatory submission, it is typically prospective for the specific batch/samples used for testing.

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

This document describes physical, chemical, and biological testing of a medical device (gloves) against established standards. It does not involve interpretation of medical images or patient data that would require "experts" in the sense of clinicians establishing ground truth on a test set. The "ground truth" for these tests is defined by the acceptance criteria within the international and national standards (ASTM, ISO) themselves.

4. Adjudication Method for the Test Set

Not applicable. The tests performed are objective measurements against predefined criteria as per established standards (ASTM, ISO), not subjective assessments requiring adjudication by multiple readers or experts.

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 done. This type of study is typically associated with diagnostic imaging or AI algorithms that require human interpretation and comparison with and without AI assistance to measure reader improvement. The device in question is a physical glove, and its performance is evaluated through standardized physical, chemical, and biological tests, not through human reader interpretation.

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

Yes, the testing described is effectively "standalone" performance in the sense that the device's characteristics are measured objectively against standards without human-in-the-loop performance in a clinical scenario being assessed for regulatory purposes. The device itself is not an algorithm, so the term "algorithm only" isn't directly applicable, but the performance evaluation is solely based on the device's intrinsic properties.

7. The Type of Ground Truth Used

The "ground truth" is defined by the acceptance criteria established in recognized international and national standards (ASTM D5250, ASTM D5151, ASTM D6124, ASTM D412, ISO 10993-5, ISO 10993-10). These standards specify objective physical, chemical, and biological parameters that the gloves must meet to be deemed safe and effective for their intended medical purpose.

8. The Sample Size for the Training Set

Not applicable. A "training set" is relevant for machine learning or AI algorithms. This document describes the non-clinical testing of a physical medical device (gloves), which does not involve machine learning models and therefore has no "training set."

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

Not applicable, as there is no training set for this type of device.

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