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Disposable Vinyl Examination Gloves 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.

Device Description

The subject device is a patient examination glove made of Poly (vinyl chloride) compound. It is Non-Sterile, Powder free and is clear in colour. The device is ambidextrous and can be worn on either the left or right hand. (Per 21 CFR 880.6250, class I). The device provides four specifications: S, M, L and XL. The device meets all the specifications in ASTM D5250-19, Standard specification for Vinyl Examination Gloves. Additionally, the gloves have been tested for biocompatibility per ISO 10993-10, ISO 10993-23, ISO 10993-5

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the "Disposable Vinyl Examination Gloves":

This document is a 510(k) summary for a medical device, which seeks to demonstrate substantial equivalence to a legally marketed predicate device. As such, it describes performance testing rather than a study proving the device meets acceptance criteria in the context of clinical AI performance. The device in question is a physical product (gloves), not an AI/software device.

Therefore, many of the requested points, especially those related to AI device performance, sample sizes for test/training sets, ground truth, experts, and MRMC studies, are not applicable to this document.

However, I can extract the acceptance criteria and reported device performance from the provided tables for the physical aspects of the gloves.

Acceptance Criteria and Reported Device Performance

1. Table of acceptance criteria and the reported device performance

CHARACTERISTICS	STANDARDS	Acceptance Criteria	DEVICE PERFORMANCE (Reported)
Dimensions	ASTM D5250-19		Pass
Length		230 mm min	240 mm min
Width (S)		$85\pm5$ mm	89-90 mm
Width (M)		$95\pm5$ mm	99 mm
Width (L)		$105\pm5$ mm	105-106 mm
Width (XL)		$115\pm5$ mm	119-120 mm
Thickness (Palm)		Min 0.08 mm	0.080 mm Min
Thickness (Finger)		Min 0.08 mm	0.080 mm Min
Physical Properties	ASTM D5250-19		Pass
Before Aging:
Tensile Strength		11 MPa, min.	16.0 MPa, min.
Elongation		300%, min.	304%, min.
After Aging:
Tensile Strength		11 MPa, min.	16.7 MPa, min.
Elongation		300%, min.	301%, min.
Freedom from holes	ASTM D5250-19,	No leakage at sampling level of	Pass
	ASTM D5151-19	G-1, AQL 2.5	No leakage, 80 of 80 passed
Residual Powder	ASTM D6124-06	<2 mg per glove	0.1 mg per glove (average)
Biocompatibility	ISO 10993-23:2021	Not an irritant	Did not induce skin irritation
(Primary Skin Irritation)
Biocompatibility	ISO 10993-10:2010	Not a sensitizer	Did not cause skin sensitization reaction
(Dermal Sensitization)
Biocompatibility	ISO 10993-5:2009	No potential toxicity to L-929_cells	Did not show potential toxicity to L-929 cells_
(In vitro Cytotoxicity)

Additional Information (As applicable to this type of device)

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Physical Performance Testing: For "Freedom from holes," the reported sample size was "80 of 80 passed." Other physical tests (dimensions, physical properties, residual powder) often rely on samples drawn from manufacturing lots according to the specified ASTM standards, but specific sample sizes for each characteristic are not explicitly stated beyond what's implied by the standards.
Biocompatibility Testing: The standards (ISO 10993 series) define the protocols and sample sizes for these tests, but specific numbers are not provided in this summary.
Data Provenance: Not explicitly stated, but assumed to be from Anqing Pukang Medical Technology Co., LTD. in China, where the device is manufactured. The tests are prospective, as they are part of the premarket notification process for the new device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

N/A. For physical and biocompatibility testing of medical gloves, "ground truth" is established by adherence to recognized international standards (e.g., ASTM, ISO) and laboratory protocols, not by expert interpretation in a clinical context. The results are quantitative measurements or observations of biological reactions performed by qualified lab personnel.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

N/A. This concept is primarily relevant to studies involving human subjective evaluation or complex diagnostic interpretation where disputes need resolution. Performance testing for gloves involves objective measurements or standardized biological assays.

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

N/A. This is a physical device, not an AI/software device. No human reader studies are relevant.

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

N/A. This is a physical device, not an AI/software device.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

For physical properties and dimensions: Standards-based objective measurements.
For freedom from holes: Pass/fail criteria based on water leak test per ASTM standards.
For residual powder: Quantitative measurement per ASTM standards.
For biocompatibility: Laboratory assays and observations of biological reactions (e.g., skin irritation, sensitization, cytotoxicity) as defined by ISO 10993 series standards.

8. The sample size for the training set

N/A. This is a physical device, not an AI/software device. No training set is used.

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

N/A. This is a physical device, not an AI/software device. No training set or associated ground truth is relevant.

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