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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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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, 80LZA; and meets all requirement of ASTM Standard D6319-10.

The document provided describes the acceptance criteria and study proving the device meets those criteria for the "Patient Nitrile Examination Gloves, Powder Free, Non-Sterile, Blue Color" by Xinwei (Shandong) Plastic and Rubber Products Co., Ltd.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

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

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 Dimension Testing. These are standard acceptance quality limits (AQLs) and inspection levels found in sampling plans (e.g., ISO 2859-1 or MIL-STD-105E). While the specific number of gloves sampled is not explicitly stated, these levels correspond to a defined sample size based on the lot size.

The data provenance is retrospective, as the tests were performed on finished products to demonstrate compliance with existing standards. The country of origin for the device manufacturer is China (Xinwei (Shandong) Plastic and Rubber Products Co., Ltd.), and the predicate device manufacturer is also from Tangshan Zhonghong Pulin Group Co., Ltd. (China, implied by other similar K-summaries for this manufacturer).

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

Not applicable to this type of device. The ground truth for this device is based on objective measurements against established engineering and biocompatibility standards, not expert medical opinion or diagnostic interpretation.

4. Adjudication Method for the Test Set:

Not applicable. This evaluation does not involve subjective interpretation requiring adjudication among experts. The tests are objective measurements.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic or interpretive devices where human readers are involved in assessing cases, often with and without AI assistance. Examination gloves are physical barriers, not diagnostic tools.

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

Not applicable. This device is not an algorithm or software requiring standalone performance testing. It is a physical product.

7. The Type of Ground Truth Used:

The ground truth used is based on established engineering standards and biocompatibility testing guidelines. Specifically:

• ASTM D6319-10 (Standard Specification for Nitrile Examination Gloves for Medical Application) for dimensions and physical properties.
• ASTM D5151-06 (Standard Test Method for Detection of Holes in Medical Gloves) or FDA 1000 ml. Water Fill Test for pinholes.
• ASTM D6124-06 (Standard Test Method for Residual Powder on Medical Gloves) for residual powder.
• ISO 10993-10 (Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization) for primary skin irritation and dermal sensitization.

8. The Sample Size for the Training Set:

Not applicable. This device is a physical product, not an AI or machine learning model that requires a training set.

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

Not applicable, as there is no training set for this device.

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