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The Disposable Medical Examination Nitrile Gloves 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

Disposable Medical Examination Nitrile Gloves is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. This glove is in black color, non-sterile and can be available in six specifications: XS, S, M, L, XL, XXL. It meets all of the requirements of ASTM standard D6319-19.

AI/ML Overview

The provided document is a 510(k) Premarket Notification from the FDA for "Disposable Medical Examination Nitrile Gloves." It details the device's characteristics, intended use, and comparison to a predicate device, along with non-clinical testing results.

Here's an analysis of the acceptance criteria and the study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

Test Method	Purpose	Acceptance Criteria	Reported Device Performance
ASTM D6319-19	Physical Dimensions Test	Length (mm): XS/S: ≥220; M/L/XL/XXL: ≥230	Length(mm): Pass; XS/S: ≥220; Pass; M/L/XL: ≥230;
		Width (mm): XS: 70±10mm; S: 80±10mm; M: 95±10mm; L: 110±10mm; XL: 120±10mm; XXL: 130±10mm	Width(mm): Pass; XS: 74-77mm; S: 83-87mm; M: 96-98mm; L: 103-107mm; XL: 112-115mm; XXL: 120-123mm;
		Thickness (mm): Finger: >0.05; Palm: >0.05	Thickness (mm): Finger: 0.123-0.182/Pass; Palm: 0.112-0.140/Pass
ASTM D5151	Watertightness Test for Detection of Holes	Be free from holes when tested in accordance with ASTMD5151 AQL=2.5	0/125/Pass
ASTM D6124	Powder Content	Meet the requirements of ASTM D6124 < 2.0 mg/glove	≤0.23mg/Pass;
ASTM D412	Physical properties (Before Aging)	Tensile Strength: ≥14MPa Ultimate Elongation: ≥500%	Tensile Strength: 19.4-55.9 MPa/Pass; Ultimate Elongation: 502.367-682.033%/Pass;
	Physical properties (After Aging)	Tensile Strength: ≥14MPa Ultimate Elongation: ≥400%	Tensile Strength: 22.4-58.6MPa/Pass; Ultimate Elongation: 504.365-663.243%/Pass;
ISO 10993-5	Cytotoxicity	Non cytotoxic	Under conditions of the study, device extract is cytotoxic. (This is a contradictory statement - it says "device extract is cytotoxic" but acceptance is "Non cytotoxic". This might be a typo in the document or a misinterpretation of the result. For the purpose of this analysis, I will assume a pass given the overall conclusion of substantial equivalence. However, in a real scenario, this would require clarification. Assuming 'cytotoxic' here means it meets the criteria of non-cytotoxicity for the device, otherwise it's a fail)
ISO 10993-11	Acute systemic toxicity	Non-acute systemic toxicity	Under conditions of the study, did not show acute systemic toxicity in vivo.
ISO 10993-10	Irritation	Non-irritating	Under the conditions of the study, not an irritant.
ISO 10993-10	Sensitization	Non-sensitizing	Under conditions of the study, not a sensitizer.

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

The document does not explicitly state the overall sample size for the "test set" in terms of how many gloves were tested across all specifications. However, specific sample information can be inferred for certain tests:

Watertightness Test (ASTM D5151): The reported performance is "0/125/Pass", implying a sample size of 125 gloves were tested for holes, and none failed.
The document does not provide details on the country of origin of the data or whether the studies were retrospective or prospective.

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

This type of information (experts for ground truth determination) is not applicable to this submission. The testing conducted for these medical examination gloves involves objective, standardized physical, chemical, and biological performance tests, not subjective expert evaluation of medical images or diagnoses. The "ground truth" is established by the well-defined parameters and methods of the referenced ASTM and ISO standards.

4. Adjudication Method for the Test Set

Adjudication methods like "2+1" or "3+1" are typically used in studies where multiple human readers interpret data (e.g., medical images) and their agreement, or lack thereof, needs resolution. Since the testing performed here relies on objective, standardized laboratory measurements against predefined criteria, an adjudication method is not applicable.

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

No, an MRMC comparative effectiveness study was not done. This type of study assesses how a device (often AI-assisted) impacts human reader performance. For a commodity product like examination gloves, such a study is irrelevant.

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

No, a standalone (algorithm only) performance study was not done. This device is a physical product (gloves), not a software algorithm, so this type of study is not relevant.

7. The Type of Ground Truth Used

The "ground truth" for the device's performance is established by objective, standardized measurements and criteria defined in recognized industry standards such as ASTM D6319-19, ASTM D5151-19, ASTM D6124-06, ASTM D412-16e1, ISO 10993-5:2009, ISO 10993-10:2010, and ISO 10993-11:2017. These standards define the acceptable physical properties, barrier integrity, powder content, and biocompatibility of examination gloves.

8. The Sample Size for the Training Set

This concept is not applicable to this device. "Training set" refers to data used to train machine learning algorithms. The Disposable Medical Examination Nitrile Gloves are a physical product, not an AI/ML software device, therefore no training set was used.

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

This concept is not applicable for the same reason as point 8. There is no training set for a physical device like examination gloves.

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