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Nitrile Powder Free Examination Gloves with Colloidal Oatmeal USP and Tested for Use with Chemotherapy Drugs -(Lemon Green) is a non-sterile disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. It is also tested to be used against Chemotherapy Drugs.

The list of Chemotherapy Drugs tested (with breakthrough times) is as below:

Carmustine (3.3 mg/ml) 5.4 minutes
Cisplatin (1.0 mg/ml) > 240 minutes
Cyclophosphamide (20.0 mg/ml) > 240 minutes
Dacarbazine (10.0 mg/ml) > 240 minutes
Doxorubicin Hydrochloride (2.0 mg/ml) > 240 minutes
Etoposide (20.0 mg/ml) > 240 minutes
Fluorouracil (50.0 mg/ml) > 240 minutes
Methotrexate (25.0 mg/ml) > 240 minutes
Mitomycin C (0.5 mg/ml) > 240 minutes
Paclitaxe 1 (6.0 mg/ml) > 240 minutes
Thiotepa (10.0 mg/ml) 35.2 minutes
Vincristine Sulfate (1.0 mg/ml) > 240 minutes

Please note that Carmustine and Thiotepa have extremely low permeation times of 5.4 minutes

Not Found

The provided document is a 510(k) premarket notification letter from the FDA regarding "Powder Free Examination Gloves with Colloidal Oatmeal USP and Tested for Use with Chemotherapy Drugs - (Lemon Green)". This document primarily concerns the regulatory approval of medical gloves and does not contain any information about an AI/ML-based medical device, its acceptance criteria, or studies proving its performance.

Therefore, I cannot extract the requested information regarding acceptance criteria and performance studies for an AI/ML device from this document. The information requested (acceptance criteria, sample sizes, expert qualifications, ground truth establishment, MRMC studies, etc.) is specific to the development and validation of AI/ML algorithms in medical devices, which is not covered in this regulatory document for examination gloves.

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

Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Power Free Vinyl Patient Examination Glove, 80 LYZ, and meets all requirements of ASTM standard D-5250-06el.

Here's an analysis of the provided text, focusing on the acceptance criteria and the study proving the device meets those criteria:

Acceptance Criteria and Device Performance for Better Care Plastic Products Co., Ltd. Powder Free Vinyl Patient Examination Glove (K092296)

1. Table of Acceptance Criteria and Reported Device Performance:

The document outlines an equivalency study based on established ASTM standards and FDA requirements rather than defining novel acceptance criteria for a new type of device. The acceptance criteria are therefore the requirements set by the cited standards for this device type.

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

• Physical and Dimensions Testing: "Inspection level S-2, AQL 4.0". The specific numerical sample size is not explicitly stated but is implicitly defined by the AQL (Acceptance Quality Limit) and inspection level (S-2) within Quality Assurance sampling plans, likely based on ANSI/ASQ Z1.4 (or equivalent) tables.
• Pinhole (Water Fill Test): "samplings of AQL 2.5, inspection level 1". Similar to above, the specific numerical sample size is not explicitly stated, but defined by AQL and inspection level. This is a common sampling plan for medical gloves.
• Biocompatibility (Primary Skin Irritation and Skin Sensitization): The specific sample size (e.g., number of test subjects or animals) is not provided.
• Residual Powder Test: The specific sample size is not provided, but it's stated to be conducted "at finished inspection."

Data Provenance: The document does not explicitly state the country of origin for the data collection for these tests. However, the submitter is "Better Care Plastic Products Co., Ltd." from "Hebei Province 050000" in China, suggesting the testing was likely conducted in or contracted by the manufacturing company in China, following international standards. The tests are retrospective, performed on manufactured products.

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

This submission describes pre-market testing for a Class I medical device (patient examination glove), which relies on objective performance measurements against established standards, not expert consensus on interpretations of complex data (like image analysis). Therefore, the concept of "experts establishing ground truth for the test set" in the context of, for example, multiple radiologists reviewing images, does not directly apply here.

The "ground truth" for glove performance is defined by the objective metrics and thresholds specified in the ASTM standards (D-5250-06e1, D-6124-06) and FDA test methods (1000 ml. Water Fill Test). The "experts" involved would be qualified laboratory technicians, engineers, and quality assurance personnel who are trained in performing these specific tests and interpreting the results according to the published standards. Their qualifications would involve training in laboratory procedures, statistical quality control, and knowledge of the relevant ASTM and FDA guidelines for medical device testing.

4. Adjudication Method for the Test Set:

Adjudication methods like "2+1" or "3+1" are typically used when there's subjective interpretation involved, such as clinical reads or image analysis, where multiple experts might disagree. In this case, the tests are objective:

• Physical dimensions are measured.
• Pinhole tests are pass/fail based on water leakage.
• Irritation/sensitization tests are based on observed reactions or lack thereof.
• Residual powder is measured quantitatively.

Therefore, a formal "adjudication method" in the sense of reconciling differing expert opinions is not applicable. The results are directly derived from the test protocols. Any potential disputes would arise from re-testing, calibration, or auditing of the testing facility, not from subjective expert disagreement on the outcome of a particular test.

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. This type of study is relevant for diagnostic devices where human readers interpret outputs, and the goal is to assess how a new technology (e.g., AI) impacts human performance. A patient examination glove is a simple physical barrier device, and its safety and effectiveness are assessed through physical, chemical, and biological testing as described, not by human reader performance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

This is not applicable as the device is a physical product (a glove), not an algorithm or AI system.

7. The Type of Ground Truth Used:

The ground truth used for demonstrating compliance is objective performance data derived from standardized laboratory tests and measurements. This includes:

• Physical Measurements: Tensile strength, elongation, dimensions, etc., against ASTM D-5250-06e1 specifications.
• Leakage/Barrier Integrity: Pass/fail rates for the FDA 1000 ml. Water Fill Test.
• Biocompatibility Data: Results from primary skin irritation and skin sensitization tests (e.g., absence of observed reactions).
• Chemical Analysis: Quantitative measurement of residual powder against ASTM D-6124-06 and the "<2 mg per glove" claim.

8. The Sample Size for the Training Set:

This question is not applicable. The device is a physical product (a glove), not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning. The manufacturing process itself (Good Manufacturing Practices) and quality control throughout production could be considered an ongoing "training" equivalent in the sense of maintaining product quality, but it's not a data-driven training set for an algorithm.

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

This question is not applicable, as there is no "training set" for this type of device.

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