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Powdered vinyl 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.

powdered vinyl patient examination gloves, white(non-colored) that meets all of the requirements of ASTM standard I) 525()-00'd

The provided text is for a 510(k) premarket notification for "Powdered Vinyl Patient Examination Gloves, White (Non-colored)." It describes the device, its intended use, and indicates its substantial equivalence to a predicate device. The information focuses on regulatory compliance based on established standards rather than a study proving the device meets acceptance criteria through clinical or comparative effectiveness trials.

Here's a breakdown based on your request, highlighting the information that is not present in the provided document, as it's not typically required for this type of device and submission:

Acceptance Criteria and Reported Device Performance

Study-Related Information (Not Applicable or Not Provided for this type of device)

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

   • Not applicable / Not provided. For examination gloves, performance is assessed against established technical standards (ASTM, CFR) through laboratory testing, not human clinical trials with "test sets" in the conventional sense of AI/diagnostic device studies. The document refers to meeting these standards rather than conducting a separate study on a specific "test set" of patient data.

2. 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):

   • Not applicable. "Ground truth" established by experts is a concept typically relevant to diagnostic devices, especially those using AI. For examination gloves, the "ground truth" is defined by the technical specifications in the ASTM standards and regulatory requirements (e.g., 21 CFR 800.20 for pinholes).

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

   • Not applicable. Adjudication methods are relevant for expert review in clinical studies or AI ground truth establishment, not for laboratory testing of a physical medical device like a glove against predefined technical standards.

4. 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:

   • No, not done, and not applicable. This type of study relates to diagnostic imaging or AI-assisted interpretation, which is entirely outside the scope of an examination glove.

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

   • No, not done, and not applicable. This applies to AI algorithms.

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

   • Standardized laboratory test results against predefined technical specifications. For example, "Freedom from pinholes" is verified by testing against 21 CFR 800.20, and "Biocompatibility" is assessed via standard animal tests (Primary Skin Irritation in rabbits, Dermal Sensitization in guinea pigs) whose results are compared to established criteria for what constitutes irritation/sensitization.

7. The sample size for the training set:

   • Not applicable / Not provided. This device does not involve a "training set" in the context of AI or machine learning. Its manufacturing and testing processes are governed by quality systems and adherence to standards.

8. How the ground truth for the training set was established:

   • Not applicable. As there is no training set for this device type, there is no ground truth to be established for it.

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Powder free vinyl 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.

powder free vinyl patient examination gloves, white(non-colored) that meets all of the requirements of ASTM standard D 5250-00-4

The provided K051935 Premarket Notification [510(k)] Summary pertains to "Powder Free Vinyl Patient Examination Gloves, White (non-colored)". This device is a medical glove, and the acceptance criteria and study detailed are for demonstrating its compliance with relevant standards and safety.

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 does not explicitly state the specific sample sizes used for each test (Dimension, Physical Properties, Freedom from pinholes, Powder Residual, Biocompatibility). It refers to meeting the requirements of the standards (ASTM D 5250-00c4, 21 CFR 800.20, D6124-01, and ISO10993-10). These standards would define the required sample sizes for such testing.

The data provenance is not explicitly stated as retrospective or prospective, nor does it mention a specific country of origin for the data (beyond the submitter's address being in China). However, generally, performance testing for medical devices like gloves is conducted prospectively on manufactured samples.

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

This information is not applicable in the context of this device and its testing. Performance criteria for medical gloves are based on established engineering and safety standards (e.g., ASTM, FDA regulations). There is no "ground truth" established by human experts in the same way it would be for an AI diagnostic device. The "ground truth" is defined by the objective measurements and pass/fail criteria of the specified standards.

4. Adjudication Method for the Test Set:

This information is not applicable. As mentioned above, the tests are objective measurements against established standards, not subjective interpretations requiring adjudication.

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 specifically relevant for diagnostic devices where human readers interpret data (e.g., medical images) with and without AI assistance to assess the AI's impact on human performance. For a patient examination glove, such a study is not relevant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

No, a standalone study was not done. This concept is also primarily applicable to diagnostic algorithms. The "device" in this case is a physical product (gloves) whose performance is assessed through laboratory testing against physical, chemical, and biological standards, not through an algorithm.

7. The Type of Ground Truth Used:

The "ground truth" used for this device is based on established objective criteria defined within recognized standards and regulations. These include:

• ASTM standard D 5250-00c4: Specifies requirements for dimensions, physical properties, and powder residue.
• 21 CFR 800.20: Relates to freedom from pinholes (waterleak test AQL).
• ASTM D6124-01: Also concerns powder residue.
• ISO10993-10: Addresses biocompatibility (primary skin irritation and dermal sensitization).

Essentially, the ground truth is the compliance with these pre-defined, measurable specifications.

8. The Sample Size for the Training Set:

This device does not have a "training set" in the typical sense of machine learning or AI. Performance testing is done on manufactured samples according to the specifications of the referenced standards. There is no algorithm being "trained."

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

As there is no training set, this question is not applicable.

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