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Micro Touch Denta Glove Nitrile Hydrasoft Patient Examination Gloves are intended for medical purposes that are worn on the examiners hands to prevent contamination between patient and examiner.

Device Description

The MICRO-TOUCH® DENTA-GLOVE® Nitrile HydraSoft™ are non-sterile, single use only, disposable, powder free examination gloves. The glove is made of nitrile butadiene rubber. A polyacrylic polymer is applied to the inner surface of the glove to make donning easy. Hydrasoft coating (containing glycerine) is applied on top of the polymer coating on the glove inner surface..

Characteristic:

Ambidextrous with beaded cuff and straight fingers
Finger-textured,
White colored
Featuring inner coating of polyacrylic polymer coating and HydraSoft™ coating.
. Five (5) sizes – extra-small, small, medium, large, and extra-large.

AI/ML Overview

The provided text describes the acceptance criteria and performance data for a medical device, the "Micro Touch Denta Glove Nitrile Hydrasoft Patient Examination Gloves."

1. Table of Acceptance Criteria and Reported Device Performance:

Characteristics	Acceptance Criteria (Standard/Test/FDA Guidance)	Reported Device Performance (Result Summary)
Physical Characteristics:	ASTM D6319-10	Meets ASTM D6319-10 requirements for length, width and thickness
Length	Minimum 230mm	Minimum 240mm
Palm width (XS)	70 ± 10 mm	75 ± 5 mm
Palm width (S)	80 ± 10 mm	85 ± 5 mm
Palm width (M)	95 ± 10 mm	95 ± 5 mm
Palm width (L)	110 ± 10 mm	105 ± 5 mm
Palm width (XL)	120 ± 10 mm	115 ± 5 mm
Thickness (mm) - single-wall	minimum 0.05 mm
Finger	minimum 0.05 mm	0.11 ± 0.03 mm
Palm	minimum 0.05 mm	0.07 ± 0.02 mm
Cuff	N/A (implied by minimum 0.05 for other areas)	0.06 ± 0.02 mm
Physical Properties:	ASTM D6319-10	Meets ASTM D6319-10 requirements for tensile strength and ultimate elongation before and after accelerated aging
Tensile Strength
Before Aging	minimum 14 MPa	minimum 17 MPa
After Aging	minimum 14 MPa	minimum 17 MPa
Ultimate Elongation
Before Aging	minimum 500%	minimum 500%
After Aging	minimum 400%	minimum 400%
Freedom from holes	ASTM D6319-10, ASTM D5151-06 (AQL 2.5)	Meets ASTM D6319-10 and ASTM D5151-06 requirements of AQL 2.5
Powder Residual	ASTM D6319-10, ASTM D6124-06 (≤ 2 mg per glove)	Meets applicable requirement for powder free; ≤ 2 mg per glove
Biocompatibility:
ISO In Vitro Cytotoxicity	ISO 10993-5:2009	Under the conditions of the study, undiluted and 1:2 dilution was cytotoxic. 1:4, 1:8, 1:16, 1:32 and 1:64 are not cytotoxic
ISO Skin Irritation Study	ISO 10993-10:2010	Under the conditions of the study, not an irritant
ISO Maximization Sensitization Study	ISO 10993-10:2010	Under the conditions of the study, not a sensitizer
ISO acute systemic toxicity	ISO 10993-11: 2006	Under the conditions of the study, no evidence of systemic toxicity

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

The document focuses on non-clinical performance data and refers to established ASTM and ISO standards for testing. Specific sample sizes for each test are not explicitly stated in this summary but would be defined within the referenced ASTM and ISO standards. The data provenance is derived from these standard-compliant tests conducted on the device. No information on country of origin of the data is provided, nor whether it is retrospective or prospective, as these terms typically apply to clinical studies.

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

This information is not applicable to this document. The "ground truth" for evaluating this device's performance is based on established engineering and biocompatibility standards (ASTM and ISO), not expert consensus in a clinical context.

4. Adjudication Method for the Test Set:

This information is not applicable. Adjudication methods are typically used in clinical studies involving human readers/interpreters, not for performance testing against established engineering standards like those for examination gloves.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, an MRMC comparative effectiveness study was not done. The document explicitly states: "A clinical study was not conducted on the subject or predicate devices." This type of study would involve human readers (e.g., medical professionals) evaluating cases, which is not relevant for this device.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

This information is not applicable given the device is a patient examination glove, not an AI algorithm. The performance evaluation is based on direct physical and chemical testing of the glove itself.

7. The Type of Ground Truth Used:

The "ground truth" for the performance evaluation of the Micro Touch Denta Glove Nitrile Hydrasoft Patient Examination Gloves are established international and national standards for medical devices, specifically:

ASTM D6319-10: Standard Specification for Nitrile Examination Gloves for Medical Application.
ASTM D5151-06: Standard Test Method for Detection of Holes in Medical Gloves.
ASTM D6124-06: Standard Test Method for Residual Powder on Medical Gloves.
ISO 10993-5:2009: Biological evaluation of medical devices – Part 5: Tests for in vitro cytotoxicity.
ISO 10993-10:2010: Biological evaluation of medical devices – Part 10: Tests for irritation and skin sensitization.
ISO 10993-11:2006: Biological evaluation of medical devices – Part 11: Tests for systemic toxicity.

8. The Sample Size for the Training Set:

This information is not applicable. "Training set" refers to data used to train machine learning algorithms. This device is a physical product, not an AI algorithm, and therefore does not have a "training set" in that context.

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

This information is not applicable for the reasons stated in point 8.

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