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HEALTH + AID PREMIUM Powderfree Nitrike Examination Glove is a single use device intended for medical purposes that is worn on the hand of health care and similar personnel to prevent contamination between the health care personnel and the patient.

HEALTH + AID® PREMIUM Powder Free Nitrile Examination Gloves meet all the current specification listed under the ASTM Specification Examination Gloves, EXCEPT for ultimate elongation before ageing. They are blue or natural white in colour and are powder free.

Here's an analysis of the provided text regarding the acceptance criteria and study for the "HEALTH + AID® PREMIUM POWDER FREE NITRILE EXAMINATION GLOVES."

It's important to note that this document is a 510(k) summary for a medical glove, which is a relatively low-risk device. As such, the type of studies and acceptance criteria are vastly different from what would be expected for a complex AI/ML-driven diagnostic device. Many of the questions you asked are geared towards AI/ML devices and therefore will not be fully answerable from this submission.

Acceptance Criteria and Device Performance

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

Missing Information (Due to device type): For medical gloves, the primary "acceptance criteria" revolve around physical properties (e.g., tensile strength, elongation, barrier integrity) defined by consensus standards like ASTM D 3578-95, rather than diagnostic accuracy metrics (sensitivity, specificity, AUC) seen in AI/ML devices. The specific numerical targets for ASTM D 3578-95 and the device's actual performance values against those targets are not detailed in this summary.

Study Details (Applicable to this device type)

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 Physical/Chemical Tests: The document states "Testing is performed as per ASTM D 3578-95 and 21 CFR 800.20." These standards specify sampling plans for testing. However, the specific number of gloves tested (sample size) for each physical property (e.g., tensile strength, elongation, freedom from holes) is not explicitly stated in this 510(k) summary.
• Data Provenance: Not explicitly stated, but typically these tests would be conducted by the manufacturer or a contracted lab. Given the submitter's address (Malaysia), it's highly probable the testing occurred there. These would be considered prospective tests performed on batches of the manufactured product.
• Sample Size for Biocompatibility Tests: For primary skin irritation and delayed contact sensitization tests:
  • Primary skin irritation: Conducted in the rabbit. Typical sample sizes for such tests involve a small number of animals (e.g., 3-6 rabbits). The exact number is not specified.
  • Delayed contact sensitization: Conducted in the guinea pig. Typical sample sizes for such tests involve a small number of animals (e.g., 10-20 guinea pigs for the test group, plus controls). The exact number is not specified.

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)

• Not applicable (N/A). For medical gloves, "ground truth" is established by adherence to physical, chemical, and biological performance standards (e.g., tensile strength values, absence of irritants). This is measured objectively by laboratory equipment and standard protocols, not by expert interpretation in the same way as an image-based diagnosis.

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

• Not applicable (N/A). Adjudication methods like 2+1 or 3+1 are used for human expert consensus in diagnostic studies (e.g., reviewing medical images). For medical gloves, performance is measured objectively against predefined specifications, not through expert consensus on qualitative observations.

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 (N/A). This device is a nitrile examination glove, not an AI/ML diagnostic system intended to assist human readers. Therefore, an MRMC study and effect size in the context of AI assistance are irrelevant.

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

• Not applicable (N/A). This device is a physical product (a glove), not an algorithm.

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

• The "ground truth" for these gloves is defined by:
  • Standard Specifications: Adherence to the physical performance requirements outlined in ASTM D 3578-95 (e.g., tensile strength, elongation, freedom from holes, dimensions). These are objective, measurable criteria.
  • Biocompatibility Standards: Results from established animal models for irritation and sensitization.
  • Chemical Tests: Specific tests like the USP iodine test for starch presence.

8. The sample size for the training set

• Not applicable (N/A). This device does not use machine learning, so there is no "training set."

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

• Not applicable (N/A). This device does not use machine learning, so there is no "training set" and thus no ground truth to establish for it in this context.

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HEALTH + AID @ PREMIUM Powderfree Latex Examination Glove is a single use device intended for medical purposes that is worn on the hand of health care and similar personnel to prevent contanination between the health care personnel and the patient.

HEALTH + AID ® PREMIUM Powder Free Latex Examination Gloves meet the current specifications listed under the ASTM Specification D 3578 - 95, Standard Specification for Rubber Examination Gloves. They are natural white in colour and are powder free.

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the "HEALTH + AID ® PREMIUM POWDER FREE LATEX EXAMINATION GLOVES":

This document is a 510(k) summary for a medical device (examination gloves), which primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a detailed performance study with comprehensive acceptance criteria and statistical analysis of an AI algorithm. Therefore, many of the requested points related to AI performance, expert ground truth, adjudication, MRMC studies, and training sets are not applicable to this type of submission.

The "acceptance criteria" for this device are the established specifications for latex examination gloves, primarily defined by the ASTM D 3578-95 standard and FDA regulations.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify a distinct "test set" in the context of an AI algorithm's performance evaluation. Instead, it refers to general product testing in accordance with established standards.

• Sample Size: Not explicitly stated for specific tests. ASTM D 3578-95 and 21 CFR 800.20 would dictate the sampling plans and lot sizes required for various tests (e.g., visual inspection for holes, physical properties, bioburden).
• Data Provenance: The testing was performed on the manufactured "HEALTH + AID ® PREMIUM POWDER FREE LATEX EXAMINATION GLOVES" themselves, presumably at the manufacturer's facility (M.R.G. INDUSTRIES SDN. BIID., Malaysia) or by a contracted lab. This would be considered prospective for the specific batches tested to support the 510(k) submission.

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

This concept is not applicable to this device and submission. "Ground truth" in this context refers to established laboratory testing methods and regulatory standards, not expert consensus on medical images or clinical observations. The "experts" would be the laboratory technicians performing the specified tests according to ASTM and FDA protocols, who are qualified in those specific testing methodologies.

4. Adjudication Method for the Test Set

This concept is not applicable. Adjudication refers to resolving disagreements among experts, which isn't relevant for standardized laboratory tests against predefined specifications.

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

This is not applicable as this is not an AI-powered diagnostic or assistive device.

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

This is not applicable as this is not an AI algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established by:

• Standardized Laboratory Test Results: Measurements of physical properties (tensile strength, elongation, etc.), chemical tests (starch presence, protein content), and biological tests (skin irritation, sensitization) performed according to internationally recognized standards like ASTM D 3578-95 and specified methodologies in 21 CFR 800.20.
• Predicate Device Equivalence: The primary "ground truth" for regulatory acceptance is demonstrating that the device is "substantially equivalent" to an already legally marketed device (Class 1 patient examination glove 80LYY which meets ASTM D 3578-95).

8. The Sample Size for the Training Set

This is not applicable as this is not an AI algorithm.

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

This is not applicable as this is not an AI algorithm.

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HEALTH + AID® PREMIUM Pre-powdered Latex Examination Glove is a single use device intended for medical purposes that is worn on the hand of health care and similar personnel to prevent contamination between the health care personnel and the patient.
100mcg/gm or less total water extractable protein per gram

HEALTH + AID® PREMIUM Pre-powdered Latex Examination Gloves meet the current specifications listed under the ASTM Specification D 3578 - 95, Standard Specification for Rubber Examination Gloves. They are

This document describes the 510(k) summary for HEALTH + AID® PREMIUM Pre-powdered Latex Examination Gloves.

Here's an analysis of the provided text with respect to your specific questions:

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

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

The document does not explicitly state the sample sizes used for testing. It refers to "Testing is performed as per ASTM D 3578-95 and 21 CFR 800.20." These standards, particularly ASTM D 3578-95, would define the sampling plans and testing methodologies.

The provenance of the data is not specified beyond being generated by the device manufacturer, M.R.G. Industries Sdn. Bhd., located in Malaysia. It is implied to be prospective testing conducted by the manufacturer for regulatory submission.

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)

This is not applicable as the device is a medical glove, not a diagnostic or AI-driven decision support system requiring expert-established ground truth. The acceptance is based on physical and biological testing against established standards.

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

This is not applicable for the type of device and testing described. Adjudication methods are typically relevant for subjective assessments, particularly in clinical trials or AI performance evaluations, not for objective material property testing.

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 or imaging device that would involve human readers or MRMC studies.

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 algorithm.

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

The "ground truth" for this device is based on objective measurements against established performance standards and biocompatibility tests. For example:

• Physical properties (e.g., tensile strength, elongation, dimensions) are measured against criteria specified in ASTM D 3578-95.
• Freedom from holes is tested per ASTM D 3578-95.
• Biocompatibility (skin irritation and sensitization) is assessed through animal studies (rabbit and guinea pig).
• Water extractable protein is measured objectively.

8. The sample size for the training set

Not applicable. The device is a physical product (glove) and does not involve AI or machine learning algorithms that require a 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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