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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 finger to prevent contamination between patient and examiner.

These gloves were tested for use with Chemotherapy Drugs and Fentanyl Citrate as per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.

Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Black), Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Orange) are made from synthetic rubber latex. It is single use and powder-free. The subject device is a patient examination glove made from nitrile latex compound, Black and Orange color, powder free and non-sterile (Per 21 CFR 880.6250, class I). The device meets all the specifications in ASTM D6319-19, Standard specification for Nitrile Examination Gloves. The available sizes are Small, Medium, Large ,X-Large and XX-Large.

Here's a breakdown of the acceptance criteria and the study information based on the provided text, formatted as requested:

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

The provided document lists various performance criteria for the Nitrile Powder Free Examination Gloves (Black and Orange) and reports the results against these criteria.

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

• Sample Size for Physical/Dimensional/Chemical Tests: For "Freedom From Holes," the sampling size is stated as 125 pieces (Ac: 7, Re: 8). The specific sample size for other physical/dimensional tests (length, width, thickness, tensile strength, elongation, residual powder content) is not explicitly stated, but the tests are reported as meeting ASTM D6319-19 and ASTM D6124-06 requirements. For Biocompatibility tests, no specific sample size is given, but the studies involve guinea pigs and rats, implying animal testing was conducted.
• Sample Size for Chemotherapy Drug Permeation Tests: Not explicitly stated within the document. The tests are reported as per ASTM D6978-05 (Reapproved 2019).
• Data Provenance: The manufacturing company is Dehai (Shandong) Medical Gloves, Co., Ltd. located in Zibo City, Shandong Province, China. The testing would presumably have been conducted in a laboratory, potentially in China or a third-party testing facility. The document doesn't specify if the data is retrospective or prospective, but testing of device performance characteristics is generally prospective for regulatory submissions.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This device is a medical glove, and its performance is evaluated against established physical, chemical, and biological standards (ASTM, ISO). There is no "ground truth" established by human experts in the way an AI diagnostic algorithm would require. The "ground truth" is defined by the objective metrics and thresholds specified in the referenced ASTM and ISO standards.

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 used for establishing consensus ground truth in studies involving human interpretation (e.g., radiology reads). This document pertains to physical and chemical testing of a medical device against predefined standards, which does not involve such 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. This document is for a medical glove, not an AI-assisted diagnostic device. Therefore, no MRMC study or AI assistance evaluation was performed.

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

Not applicable. This device is a medical glove, not an algorithm or AI system.

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

The "ground truth" for this device's performance is based on established industry standards and objective material properties. Specifically:

• ASTM D6319-19: Standard specification for Nitrile Examination Gloves.
• ASTM D5151-19: Standard test methods for detection of holes in medical gloves.
• ASTM D6124-06: Standard test method for residual powder on medical gloves.
• ASTM D6978-05 (Reapproved 2019): Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
• ISO 10993-23, ISO 10993-10, ISO 10993-11: Biocompatibility standards for medical devices (Primary Skin Irritation, Skin Sensitization, Acute Systemic Toxicity).

These standards define the acceptable range or threshold for each characteristic (e.g., minimum tensile strength, maximum powder residue, minimum breakthrough time for drugs).

8. The sample size for the training set

Not applicable. This device is a medical glove, not a machine learning model, so there is no 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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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 Nitrile Patient Examination Glove, 80LA, and meets all requirement of ASTM Standard D6319-10.

Device Acceptance Criteria and Performance Study Analysis:

1. Table of Acceptance Criteria and Reported Device Performance:

Study Proving Device Meets Acceptance Criteria:

The study to prove the device met acceptance criteria was a comparison to a predicate device (K082598), Tangshan Zhonghong Pulin Group Co., Ltd. Synthetic Nitrile Patient Examination Gloves - Powder Free. The subject device, Dehai (Shandong) Medical Gloves, Co., Ltd. Nitrile Examination Gloves - Powder Free, Blue Color, was asserted to be "substantially equivalent" in all technological characteristics to the predicate device.

The study involved non-clinical tests based on ASTM-D-6319-10 for physical and dimensions testing, and the FDA 1000 ml. Water Fill Test for pinhole detection. Additionally, biocompatibility testing (Primary Skin Irritation and Skin Sensitization) was conducted based on ISO 10993-10.

2. Sample Sizes Used for the Test Set and Data Provenance:

• Pinhole Testing (Water Fill Test): AQL 2.5, Inspection Level I, sampling of 125 pieces (gloves were found to have less than two pinholes out of 125).
• Physical and Dimensions Testing (Tensile Strength, Elongation, Length, Width, Thickness): Inspection Level S-2 AQL 2.5. The specific sample size for each test within this category is not explicitly stated beyond "samplings of AQL 2.5."
• Residual Powder: According to ASTM D6124-06. The specific sample size is not explicitly stated.
• Biocompatibility (Primary Skin Irritation and Skin Sensitization): Not explicitly stated, but testing was conducted with results showing no primary skin irritant or sensitizing reactions.

Data Provenance: The data appears to be prospective as these tests were conducted on the subject device by the manufacturer (Dehai (Shandong) Medical Gloves, Co., Ltd.) to demonstrate substantial equivalence to the predicate device. The country of origin of the data is China, where the manufacturing company is located.

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

The document does not mention the use of experts to establish ground truth for this type of medical device (examination gloves). The ground truth is established by standardized testing protocols (ASTM, ISO, FDA Water Fill Test) and comparisons against predefined criteria or a predicate device's characteristics. There's no indication of human expert interpretation for physical or chemical properties of the gloves.

4. Adjudication Method for the Test Set:

Not applicable. This type of device evaluation (physical and chemical properties of gloves) does not typically involve human adjudication in the way medical imaging or diagnostic devices might. Results are obtained directly from standardized tests and compared against numerical criteria or the properties of the predicate device.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study:

No, an MRMC comparative effectiveness study was not conducted. This type of study focuses on the effectiveness of human readers, typically in interpreting medical images or diagnostic information, which is not relevant for the evaluation of examination gloves.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study:

Not applicable. This device is a physical medical glove, not an algorithm or AI system. Therefore, standalone performance (without human-in-the-loop) is not a relevant concept for its evaluation.

7. Type of Ground Truth Used:

The ground truth used is primarily standardized test results and direct measurement data compared to established industry standards (ASTM-D-6319-10, ASTM D6124-06, ASTM D5151-06, ISO 10993-10) and the characteristics of a predicate device. It's a "pass/fail" or "meets specification" type of ground truth based on objective measurements rather than expert consensus on a diagnostic outcome or pathology.

8. Sample Size for the Training Set:

Not applicable. This device is a physical product and does not involve AI or machine learning, thus there is no "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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