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A PATIENT EXAMINATION GLOVES IS A DISPOSABLE DEVICE INTENDED FOR MEDICAL PURPOSE THAT IS WORN ON THE EXAMINER'S HAND OR FINGERS TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.

Device Description

Classified by FDA's General and Plastic Surgery Device panel as Class 1, 21 CFR 880.6250, Powder-Free Vinyl Patient Examination Glove, 80LYZ, and meets all requirements of ASTM Standard D5250-06.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Rich Mountain Medical Products Ltd. Disposable Vinyl Synthetic Examination Gloves, Powder Free, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Standard / Test)	Performance Requirement	Reported Device Performance
ASTM D5250-06 (Physical and Dimensions Testing)	Meets all requirements	"All testing meets requirements for Physical and Dimensions Testing conducted on gloves, Inspection level S-2, AQL 4.0."
FDA 1000 ml Watertight Test (ASTM D-5151-06)	AQL 2.5, Inspection level I	"meeting these requirements."
Primary Skin Irritation	No primary skin irritant reactions	"no primary skin irritant reactions"
Skin Sensitization (Allergic Contact Dermatitis)	No sensitization reactions	"no...sensitization reactions"
Residual Powder (ASTM D6124-06 for Starch)	No more than 2 mg powder per glove (for "powder-free" claim)	"to insure that our gloves meet our 'powder-free' claims (contain no more than 2 mg powder per gloves)"

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

Sample Size:
- For Physical and Dimensions Testing (ASTM D5250-06): Inspection level S-2, AQL 4.0 (The exact numerical sample size is not explicitly stated but is defined by the AQL and inspection level, which are standard sampling methods).
- For FDA 1000 ml Watertight Test (ASTM D-5151-06): AQL 2.5, Inspection level I (Again, the exact numerical sample size is not explicitly stated but is defined by these parameters).
- For Primary Skin Irritation and Skin Sensitization: Not specified beyond "testing was conducted."
- For Residual Powder Test: Not specified beyond "samplings."
Data Provenance: The manufacturing company is Rich Mountain Medical Products Ltd., located in China (Jiangsu Province). The testing appears to have been conducted by or for the manufacturer. The data is retrospective relative to the submission date, as it reflects tests performed on manufactured batches of gloves.

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

This type of information is not applicable to this device. This is a Class I medical device (patient examination glove), and the testing involves objective measurement against performance standards (e.g., physical properties, watertight integrity, chemical residue, biocompatibility), not subjective assessments requiring expert consensus on a "ground truth" for diagnostic or interpretative accuracy.

4. Adjudication Method for the Test Set

This information is not applicable. The tests are objective measurements against established standards, not subjective assessments requiring adjudication.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic or AI-assisted interpretation devices. The device in question is a physical barrier (examination glove), and its effectiveness is measured by its physical properties and barrier integrity, not by human reader performance or AI assistance.

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

No, a standalone algorithm performance study was not done. This device does not involve an algorithm or AI.

7. The Type of Ground Truth Used

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

Established ASTM Standards: D5250-06 (Physical and Dimensions), D-5151-06 (Watertight), D6124-06 (Residual Powder).
Biocompatibility Testing: Results showing "no primary skin irritant or sensitization reactions."
Regulatory Requirements: FDA's 1000 ml Watertight Test and good manufacturing practices.

These standards and direct measurements form the objective "ground truth" against which the glove's performance is evaluated.

8. The Sample Size for the Training Set

Not applicable. This device does not use machine learning or AI, and therefore does not have a "training set" in the conventional sense. The "training" for the manufacturing process would be quality control and adherence to manufacturing specifications.

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

Not applicable. As there is no AI/ML component, there is no "training set" or "ground truth" for such a set. The manufacturing process's "ground truth" is adherence to quality control parameters and the specifications outlined in the ASTM standards.

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