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Powder Free White Vinyl Patient Examination Gloves is a non sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Powder-Free White Vinyl Patient Examination Gloves that meets all of the requirements of ASTM standard D 5250-06(Reaffirmation 2011).

This document describes the 510(k) premarket notification for Zibo Goldenline Plastic Products Company, Ltd.'s Powder-Free White Vinyl Patient Examination Gloves (K141613). The primary purpose of this submission is to demonstrate substantial equivalence to a legally marketed predicate device, Tangshan Hengda Plastic Products Co., Ltd.'s Powder-Free Vinyl Patient Examination Gloves (K102558).

The document details the acceptance criteria used for the device, which are based on established ASTM and ISO standards for patient examination gloves. It then discusses the nonclinical tests conducted to prove that the device meets these criteria.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Powder-Free White Vinyl Patient Examination Gloves are primarily derived from various ASTM standards and 21 CFR 800.20, including:

• ASTM D5250-06 (Reaffirmation 2011): Standard Specification for Poly(vinyl chloride) Gloves for Medical Application. This standard covers physical dimensions (length, width, thickness) and physical properties (tensile strength, elongation before and after aging).
• ASTM D5151-06 (Reapproved 2011): Standard Test Method for Detection of Holes in Medical Gloves. This standard specifies the inspection level and Acceptable Quality Limit (AQL) for pinholes.
• ASTM D6124-06 (Reaffirmation 2011): Standard Test Method for Residual Powder on Medical Gloves. This standard sets the limit for residual powder.
• 21 CFR 800.20: General requirements for examination gloves, specifically regarding freedom from pinholes.
• ISO 10993-10 Third Edition 2010-08-01: Biological evaluation of medical devices – Part 10: Tests for irritation and skin sensitization.

The device performance is compared against these standards and the predicate device.

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

The document does not explicitly state the specific sample sizes used for each individual test (e.g., length, width, tensile strength, pinholes, residual powder, biocompatibility). However, it consistently refers to meeting established ASTM standards. ASTM standards typically specify sampling plans and acceptable quality levels (AQLs) for these tests during manufacturing and quality control. For instance, ASTM D5151 for pinholes specifies an "Inspection Level I" and "AQL 2.5".

Data Provenance: The tests and data appear to be generated by the manufacturer, Zibo Goldenline Plastic Products Company, Ltd., in China, as indicated by the company's address and the origin of the submission. The studies are retrospective in the sense that they are presenting results from routine testing or specific evaluations conducted to demonstrate compliance with standards for the device under review.

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

This section is not applicable as the device is a medical glove, not an AI/ML powered device requiring expert-established ground truth on data. The "ground truth" for the performance of the gloves is established by objective measurements and adherence to specified physical, chemical, and biological performance standards (ASTM, ISO).

4. Adjudication Method for the Test Set

This section is not applicable. The assessment relies on direct measurements against quantifiable standards rather than subjective human interpretation requiring adjudication.

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

This section is not applicable. The device is a patient examination glove, not an AI-assisted diagnostic or prognostic system. Therefore, MRMC studies are not relevant.

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

This section is not applicable. This device is a physical medical product, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the device's performance is established by objective, standardized measurements and compliance with recognized industry standards. These include:

• Physical measurements: Length, width, thickness as per ASTM D5250.
• Performance metrics: Tensile strength and elongation (before and after aging) as per ASTM D5250.
• Defect detection: Freedom from pinholes with specific AQL as per ASTM D5151 and 21 CFR 800.20.
• Chemical properties: Residual powder amount as per ASTM D6124.
• Biocompatibility test results: Specifically, dermal irritation and sensitization studies as per ISO 10993-10, which provide objective assessments of biological response.

8. The Sample Size for the Training Set

This section is not applicable. There is no "training set" in the context of a physical examination glove. The manufacturing process is controlled to produce gloves consistently meeting specifications, and quality control tests are conducted on samples from production batches.

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

This section is not applicable as there is no training set for this device.

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A patient examination glove is a disposable device intended for medical purposes that is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste or environment.
A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands or finger to prevent contamination between patient and examiner (21CFR 880.6250)

Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Powder-Free Vinyl Patient Examination Glove, 80LYZ, and meets all requirement of ASTM Standard D5250-00.

The provided text is a 510(k) summary for Zibo Goldenline Plastic Products Co., Ltd. Synthetic Vinyl Patient Examination Gloves - Powder Free. This document pertains to the regulatory submission for a medical device (examination gloves), and thus, the concepts of "acceptance criteria," "study," "training set," "test set," "ground truth," and "experts" as they relate to advanced AI/ML algorithms or diagnostic devices are not directly applicable in the same way.

The document primarily focuses on demonstrating substantial equivalence of the gloves to a predicate device, as required for Class I medical devices. This involves showing that the device meets established industry standards and biocompatibility requirements.

Here's an interpretation of your request based on the provided document:

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

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 Testing: The document mentions "samplings of AOL 2.5, Inspection Level I" for the FDA 1000 ml Water Fill Test, and "Inspection Level S-2, AOL 2.5" for Physical and Dimensions Testing. These are Acceptable Quality Level (AQL) standards used in statistical quality control for batch inspection, not a fixed sample size in the traditional sense of a clinical study. The AQL specifies the maximum percentage of defective units considered acceptable in a batch. To determine the exact sample size for a given batch size, one would need to refer to military standard tables (e.g., MIL-STD-105E or ISO 2859-1) for single-sampling plans based on the specified inspection levels and AQLs. The document does not explicitly state the number of gloves sampled.
• Data Provenance: The testing was conducted by Zibo Goldenline Plastic Products Co., Ltd. in Zibo, Shandong, China. The testing would have been prospective, as it was performed on the manufactured gloves to assess their quality against the standards.

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 concept is not applicable. For an examination glove, "ground truth" is established by adherence to predefined physical and chemical specifications and performance standards (like ASTM-D-5250-00 and FDA water fill test). The "experts" are the testing personnel and the certifying bodies who verify compliance with these standards, not medical experts establishing a diagnostic ground truth.

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

Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies where multiple human readers interpret data to resolve discrepancies. For physical product testing, results are objective measurements against a standard, not subjective interpretations 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

Not applicable. MRMC studies are relevant for diagnostic or AI-assisted interpretation devices. This document describes a physical medical device (gloves) and does not involve human interpretation or AI.

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

Not applicable. This device is not an algorithm.

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

The "ground truth" for the examination gloves is defined by:

• Industry Standards: Adherence to ASTM-D-5250-00 for physical properties and dimensions.
• Regulatory Requirements: Meeting FDA's 1000 ml Water Fill Test for barrier integrity and specific biocompatibility requirements (primary skin irritation, skin sensitization).
• Manufacturer Specifications: Meeting internal "powder-free" claims (≤ 2 mg powder per glove).

These are objective, measurable criteria, not subjective expert consensus or diagnostic outcomes.

8. The sample size for the training set

Not applicable. There is no "training set" in the context of examination glove manufacturing and regulatory submission. Training sets are relevant for machine learning algorithms.

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

Not applicable. As there's no training set, there's no ground truth for it.

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