Search Results

The Powder Free Nitrile Examination Glove is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.

Device Description

The proposed device, Powder Free Nitrile Examination Glove is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.

The proposed devices are Powder Free Nitrile Examination Gloves and include variations of different sizes from X-Small to X-large. The color of the proposed device is Blue and Indigo

The proposed device is not provided as sterilized The proposed device is made of Nitrile.

AI/ML Overview

The provided document is a 510(k) Pre-Market Notification for a Powder Free Nitrile Examination Glove. The document focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing, rather than a study proving the device meets acceptance criteria for an AI/CADe system. Therefore, I cannot provide details related to AI/CADe specific criteria such as ground truth, expert adjudication, or MRMC studies.

However, I can extract the acceptance criteria and reported device performance for the glove itself, based on the non-clinical tests described in Section 8.0, "Summary of Non-Clinical Testing."

Here is the requested information for the medical glove, structured as closely as possible to your prompt, while acknowledging the limitations of the provided document for AI/CADe specific questions:

1. A table of acceptance criteria and the reported device performance

Test Method	Purpose	Acceptance Criteria (Proposed Device)	Reported Device Performance (Proposed Device - Blue/Indigo)
ASTM D5151	Testing for Freedom from holes	Freedom from holes (AQL: 1.5)	No water leakage inspected from 200 samples.
ASTM D6124	Determine the powder residue for powder free gloves	< 2.0 mg per glove	Residual Powder: Average 0.38 mg.
ASTM D6319 (Physical Properties)	Testing for Physical property characteristics	Before Aging: Tensile Strength: 15 MPa, min Ultimate Elongation: 500 % min After Aging: Tensile Strength: 14 MPa, min Ultimate Elongation: 500 % min	Before Aging: Tensile Strength: ≥ 17 MPa Ultimate Elongation: ≥ 512% After Aging: Tensile Strength: ≥ 17 MPa Ultimate Elongation: ≥ 508%
ASTM D6319 (Dimensions)	Testing For physical dimensions specification	Length: 230 mm ±10 for all size (XS, S, M, L, XL)Width: 70±10 mm for XS; 80±10 mm for S; 95±10 mm for M; 110±10 mm for L; 120±10 mm for XL.Finger Thickness: 0.12±0.03 mmPalm Thickness: 0.10±0.03 mmAll acceptance criteria above meet the requirements in Table 2 Dimensions and Tolerances of ASTM D6319	Length of Size XS: ≥ 229 mm; Width of Size XS: ≥70 (70-73) mm; Palm Thickness of Size XS: ≥0.09 mm; Finger Thickness of Size XS: ≥0.11 mm.Length of Size S: ≥ 230 mm; Width of Size S: ≥85 (85-86) mm; Palm Thickness of Size S: ≥0.09 mm; Finger Thickness of Size S: ≥0.11 mm.Length of Size M: ≥ 230 mm; Width of Size M: ≥95 (95-96) mm; Palm Thickness of Size M: ≥0.09 mm; Finger Thickness of Size M: ≥0.11 mm.Length of Size L: ≥ 230 mm; Width of Size L: ≥108 (108-110) mm; Palm Thickness of Size L: ≥0.09 mm; Finger Thickness of Size L: ≥0.11 mm.Length of Size XL: ≥ 230mm; Width of Size XL: ≥120 (120-121) mm; Palm Thickness of Size XL: ≥0.09 mm; Finger Thickness of Size XL: ≥0.11 mm.
ISO 10993-11	Evaluate the endpoint of systemic toxicity for biocompatibility	The test article showed "negative" systemic toxicity.	Under the conditions of the study, the test article showed "negative" systemic toxicity.
ISO 10993-10 (Irritation)	Evaluate the endpoint of irritant for biocompatibility	The response of the test article has no skin irritation.	Under the experimental conditions, the test article has no skin irritation on rabbits.
ISO 10993-10 (Sensitization)	Evaluate the endpoint of sensitization for biocompatibility	The test article showed no evidence of causing delayed dermal contact sensitization.	The test article showed no evidence of causing delayed dermal contact sensitization in the guinea pig.

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

Sample Size for Test Set:
- For "Freedom from holes" (ASTM D5151), the results state "No water leakage is inspected from 200 samples."
- For other tests (powder residue, physical properties, dimensions, biocompatibility), specific sample sizes are not explicitly stated in the summary tables, beyond what would typically be required by the respective ASTM/ISO standards.
Data Provenance: Not specified in the provided document. It implicitly refers to non-clinical bench testing and in vivo animal biocompatibility studies rather than human clinical data or geographical data. The applicant is based in China, suggesting the testing might have been conducted there, but this is not confirmed.
Retrospective or Prospective: Not applicable as these are bench and animal tests, not human studies.

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

This is not applicable as the device is a medical glove, and "ground truth" as typically defined for AI/CADe (e.g., diagnostic accuracy) is not relevant for its performance evaluation for this 510(k) submission. The "ground truth" is based on the physical and chemical properties measured against established standards.

4. Adjudication method for the test set

Not applicable for the reasons stated in point 3. The evaluation is based on objective measurements against predefined standard thresholds.

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 is a medical glove, not an AI/CADe system.

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

Not applicable. This is a medical glove, not an AI/CADe system.

7. The type of ground truth used

The "ground truth" for the device's performance is established by objective measurements and results from standardized non-clinical tests (per ASTM and ISO standards) and animal biocompatibility studies, comparing these results directly against the specified acceptance criteria within those standards. This process does not involve expert consensus in the diagnostic sense, pathology data, or outcomes data related to disease.

8. The sample size for the training set

Not applicable. This is a medical glove, not an AI/CADe system; there is no "training set."

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

Not applicable. There is no training set for this type of device.

Ask a Question

Ask a specific question about this device

Page 1 of 1