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The powder free vinyl patient examination glove (non-sterile) 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. It is sold as non-sterile.

Powder Free Vinyl Patient Examination Gloves (Non-Sterile), that meets all of the requirement of ASTM standard D 5250-06, except for sterility requirements.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Powder Free Vinyl Patient Examination Gloves (Non-Sterile):

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not explicitly state the sample size used for the test set for each characteristic. It refers to meeting ASTM standards (D 5250-06, D5151-06, D6124-06) for physical properties, dimensions, freedom from pinholes, and powder residual. These standards typically define sampling plans and test methods.

For biocompatibility testing:

• Primary Dermal Irritation in Rabbits (ISO): The number of rabbits used is not explicitly stated, but ISO standards for dermal irritation typically involve a small number of animals (e.g., 3 rabbits).
• Guinea Pig Closed Patch Sensitization Test (ISO): The number of guinea pigs used is not explicitly stated, but ISO standards for sensitization testing typically involve a defined number of animals (e.g., 10-20 guinea pigs for the induction phase and a similar number for the challenge phase).

Data Provenance: The studies were conducted by the applicant, LPL (Hui Zhou) Glove Co., Ltd. The country of origin for the data is implied to be China, where the company is located. The studies are prospective as they were conducted to demonstrate the performance of the applicant's device.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

Not applicable. This device (patient examination gloves) does not involve a diagnostic algorithm requiring expert-established ground truth. The evaluation relies on standardized physical, chemical, and biological testing.

4. Adjudication Method for the Test Set:

Not applicable. No expert adjudication was performed as the evaluation is based on objective measurements against established standards.

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

Not applicable. This device is a physical product (gloves) and does not involve AI or human interpretation of cases. Therefore, an MRMC study is not relevant.

6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance:

Not applicable. This device is not an algorithm or AI system.

7. Type of Ground Truth Used:

The ground truth for the performance evaluations (Dimensions, Physical Properties, Freedom from Pinholes, Powder Residual, Biocompatibility) is based on established industry standards and regulatory requirements. Specifically:

• ASTM Standards: ASTM D 5250-06, ASTM D5151-06, ASTM D6124-06. These standards define the test methods, acceptance limits, and sampling plans for the respective characteristics.
• Regulatory Standard: 21 CFR 800.20 (for freedom from pinholes, as referenced for the predicate device).
• ISO Standards: For biocompatibility testing (Primary Dermal Irritation and Guinea Pig Closed Patch Sensitization Test), implying adherence to ISO biological evaluation standards.

8. Sample Size for the Training Set:

Not applicable. This device is not an AI or machine learning model, so there is no "training set."

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

Not applicable. (See #8)

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

Powder-Free Vinyl Non-Sterile Examination Glove

The provided text is a 510(k) clearance letter from the FDA for a Powder-Free Vinyl Non-Sterile Examination Glove. This document pertains to the regulatory clearance of a medical device, specifically a physical product (gloves), and not a digital health device or AI/ML-based software.

Therefore, the requested information about acceptance criteria for a device's performance, human reader studies, AI/ML training, and ground truth establishment is not applicable to this document. The FDA letter confirms the device's substantial equivalence to a legally marketed predicate device based on its intended use as a patient examination glove to prevent contamination, and its adherence to general controls and good manufacturing practices. There is no mention of a study involving performance metrics like sensitivity, specificity, or AUC, as these are typically associated with diagnostic or AI-driven devices.

Ask a specific question about this device

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

Powder-Free Non-Sterile Vinyl Examination Gloves

I am sorry, but based on the provided text, there is no information about acceptance criteria or a study proving that a device meets any acceptance criteria. The document is a 510(k) clearance letter from the FDA for "Vinyl Exam Gloves, Powder-Free," indicating that the device has been determined to be substantially equivalent to a legally marketed predicate device.

The information provided only discusses:

• The FDA's decision to allow the marketing of the device.
• The regulatory class and product code.
• General controls provisions.
• Directions for further information or questions regarding labeling, promotion, and advertising.
• The "Indications For Use" statement for the gloves.

Therefore, I cannot provide the requested table or answer the specific questions about acceptance criteria, study details, sample sizes, ground truth, or expert qualifications, as this information is not present in the provided text.

Ask a specific question about this device