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A latex surgeon's glove is a device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.

The proposed device, Latex Surgeon's Gloves (Powdered and Powder Free) is a sterilized and disposable medical glove intended to be worn by operating room personnel to protect a surgical wound from contamination. The proposed device is made of natural rubber latex, per standard ASTM D3577-0961, the rubber surgical gloves classification is: "Type I - gloves compounded primarily from natural rubber latex". The proposed device includes Powdered and Powder Free Latex Surgeon's Gloves, and variations of different size. All variations share the same color, creamy white. The proposed device is provided radiation sterilized to achieve the Sterility Assurance Level (SAL) of 10-6 and place in a sterility maintenance package to ensure a shelf life of 3 years.

This document describes the performance testing for "Annuy Latex Surgeon's Gloves (Powdered and Powder Free)" to demonstrate substantial equivalence to a predicate device (K130301). The study is a non-clinical bench test study.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The device performance is compared against various ASTM and ISO standards. The tables below summarize the acceptance criteria (standards) and the reported device performance for both powdered and powder-free gloves.

For Powdered Latex Surgeon's Gloves:

For Powder-free Latex Surgeon's Gloves:

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

• Sample Size: The document does not explicitly state the exact sample size for each test. For example, for "Palm width," it provides a range of measured values (e.g., 76~80 mm for size 6) rather than listing individual measurements or a specific count of gloves tested. However, the tests are stated to comply with referenced ASTM and ISO standards, which typically specify minimum sample sizes for such evaluations.
• Data Provenance: The testing was conducted by Anhui Anyu Latex Products Co., Ltd in China. It is a retrospective study since the data is collected and presented after the manufacturing and testing of the gloves.

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

This document describes non-clinical, bench testing of physical and chemical properties of a medical device (surgical gloves). As such, "ground truth" is established by adherence to recognized international standards (ASTM and ISO). There are no human experts used to establish a clinical ground truth for this type of test.

4. Adjudication Method for the Test Set

Not applicable. The product performance is evaluated against objective, standardized criteria defined by ASTM and ISO specifications, not subjective human assessment requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This is a non-clinical bench test report for physical and chemical properties of gloves, not a clinical study involving human readers or cases.

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

This refers to a medical device, specifically surgical gloves, and not an algorithm or AI. Therefore, this question is not applicable. The performance described here is the inherent physical and chemical properties of the manufactured glove itself, which are measured using various testing methodologies.

7. The Type of Ground Truth Used

The "ground truth" for the test results is established by objective, quantitative measurements against the pre-defined specifications and acceptance criteria outlined in the referenced ASTM and ISO standards (e.g., ASTM D3577-09e1 for dimensions and physical properties, ASTM D5151-11 for freedom from holes, ASTM D6124-11 for powder amount, ASTM D5712-10 for protein content, ISO 10993-10 for biocompatibility, and ISO 11137-1:2006 for sterilization).

8. The Sample Size for the Training Set

Not applicable. This is a report on the testing of a manufactured medical device, not an AI/ML algorithm development. There is no concept of a "training set" in this context.

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

Not applicable. As explained above, this is not an AI/ML algorithm study.

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A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner.

Annuy Latex Patient Examination Glove (powdered and powder-free) is a glove made from natural rubber that covers the hand up to the wrist. It is cuffed and equally wearable on either hand, free from differentiation between the left hand and the right. It has three sizes, i.e., large, medium, and small. All variations share the same natural color, creamy white. The glove is non-sterile and is for single use only, to be discarded after each examination is performed. It acts as a barrier between the examiner and the subject being examined in order to prevent contamination between them.

Annuy Nitrile Patient Examination Glove (powdered and powder-free) is a glove made from nitrile butadiene rubber Latex that covers the hand up to the wrist. It is cuffed and equally wearable on either hand, free from differentiation between the left hand and the right. It has three sizes, i.e. large, medium, and small. All variations share the same blue color. The glove is non-sterile and is for single use only, to be discarded after each examination is performed. It acts as a barrier between the examiner and the subject being examined in order to prevent contamination between them.

The provided documents detail the acceptance criteria and performance study for four types of examination gloves: Powdered Latex, Powder-free Latex, Powdered Nitrile, and Powder-free Nitrile.

1. Table of Acceptance Criteria and Reported Device Performance

Device: Annuy Latex Patient Examination Gloves (Powdered)

Device: Annuy Latex Patient Examination Gloves (Powder-free)

Device: Annuy Nitrile Patient Examination Gloves (Powdered)

Device: Annuy Nitrile Patient Examination Gloves (Powder-free)

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

The document does not explicitly state the exact "sample size used for the test set" (i.e., the number of individual gloves tested for each characteristic). However, it references specific ASTM and ISO standards that govern testing procedures for these types of gloves. These standards typically define sampling plans, AQL (Acceptable Quality Level) for certain tests (like freedom from holes), or specify the number of specimens for physical property testing. For example, for "Freedom from Holes," AQL values are given (2.5 for Inspection Level I for latex, 2.5 for Inspection Level G-1 for nitrile), implying a sampling plan was followed.

The data provenance is Anhui Anyu Latex Products Co., Ltd in Bengbu, Anhui, China, as they are the manufacturer and submitter of the 510(k) premarket notification. The data appears to be from retrospective testing conducted by the manufacturer to demonstrate compliance with the referenced standards.

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

This section is not applicable as the described tests are laboratory-based, objective performance measures (e.g., dimensions, physical properties, chemical residue, biocompatibility) of physical devices (gloves) against established engineering and safety standards. They do not involve interpretation of complex data (like medical images) by human experts to establish ground truth in the way medical AI or diagnostic devices would.

4. Adjudication Method for the Test Set

This is not applicable for the same reason as point 3. The assessment criteria are derived from objective measurements against specified standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document explicitly states: "Clinical data was not included in this submission." The evaluation focused entirely on technical and physical performance metrics of the gloves against recognized standards.

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

This is not applicable. The device is a patient examination glove, a physical product, not an algorithm or AI system. Therefore, the concept of a "standalone" algorithmic performance is irrelevant. The tests performed are standalone in the sense that they assess the intrinsic properties of the glove material and manufacturing.

7. The Type of Ground Truth Used

The ground truth used for performance evaluation is based on established industry standards and regulatory requirements. Specifically, these include:

• ASTM (American Society for Testing and Materials) Standards:
  • ASTM D3578-10 (Standard Specification for Rubber Examination Gloves)
  • ASTM D6319-10 (Standard Specification for Nitrile Examination Gloves for Medical Application)
  • ASTM D5151-11 (Standard Test Method for Detection of Holes in Medical Gloves)
  • ASTM D6124-11 (Standard Test Method for Residual Powder on Medical Gloves)
  • ASTM D5712-10 (Standard Test Method for the Analysis of Aqueous Extractable Protein in Natural Rubber Products Using the Modified Lowry Method)
• ISO (International Organization for Standardization) Standard:
  • ISO 10993-10 (Biological Evaluation of Medical Devices - Part 10: Tests for Irritation and Skin Sensitization)

These standards define the acceptable ranges or thresholds for various physical, chemical, and biological properties of examination gloves.

8. The Sample Size for the Training Set

This is not applicable. The device is a physical product (medical glove), not an AI/ML model that requires a training set. The manufacturing process of the gloves would involve quality control and process monitoring, but this is distinct from training a software algorithm.

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

This is not applicable as there is no training set for a physical medical device like an examination glove.

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