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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.

Classified by FDA's General and Plastic Surgery Device panel as Class 1, 21 CFR 880.6250, Powder-Free Vinyl Patient Examination Glove, 80LYZ, and meets all requirements of ASTM Standard D5250-00E4.

The provided text describes a 510(k) submission for "Shanghai Antares Industries Inc. Disposable Powder Free Vinyl Synthetic Exam Gloves, With Vitamin Complex, Nopal and Lanolin (Blue Color)". Medical gloves are Class I devices and generally demonstrate substantial equivalence through performance testing against recognized standards.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

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

2. Sample size used for the test set and the data provenance

• Physical and Dimensions Testing: Inspection level S-2, AQL 4.0. The specific sample size is not explicitly stated but is implicitly defined by the ASTM D5250-00E4 standard and the AQL.
• Watertight Integrity: Inspection level I, AQL 2.5. The specific sample size is not explicitly stated but is implicitly defined by the ASTM D-5151-99 standard and the AQL.
• Powder-Free Claim: Not explicitly stated, but the test (ASTM D6124-01) is conducted at "finished inspection".
• Primary Skin Irritation and Skin Sensitization: Sample size for these biocompatibility tests is not explicitly mentioned.

The data provenance is prospective manufacturing testing of the Shanghai Antares Industries Inc. gloves. The country of origin of the data is implicitly China, where the manufacturer (Shanghai Antares Industries Inc.) is located.

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

This type of device (patient examination gloves) does not typically involve human expert interpretation for establishing ground truth in the same way an imaging AI algorithm would. The "ground truth" is established by the objective measurement against the specified ASTM standards and FDA test methods. Therefore, the concept of "number of experts" or their "qualifications" for ground truth establishment is not applicable here.

4. Adjudication method for the test set

Not applicable. 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, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is a medical device (examination gloves), not an AI algorithm for diagnosis or interpretation that would typically require an MRMC study comparing human performance with and without AI.

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

Not applicable. This is a physical medical device.

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

The ground truth for this device is based on objective performance standards and test methodologies established by ASTM (American Society for Testing and Materials) and FDA. For example:

• Physical properties (dimensions, tensile strength) are objectively measured against limits defined in ASTM D5250-00E4.
• Watertight integrity (pinhole) is objectively measured against the criteria in ASTM D-5151-99.
• Powder content is objectively measured against the limit of 2 mg per glove using ASTM D6124-01.
• Biocompatibility (skin irritation and sensitization) results are based on standardized biological testing protocols.

8. The sample size for the training set

Not applicable. This is a physical medical device, not a machine learning model, so there is no "training set" in the computational sense. The "training" would be analogous to the manufacturing process adhering to quality controls.

9. How the ground truth for the training set was established

Not applicable. As explained above, there is no "training set" for a physical device in the context of an AI algorithm. The manufacturing process is designed to produce gloves that inherently meet the established performance standards.

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A PATIENT EXAMINATION GLOVE IS A DISPOSABLE DEVICE INTENDED FOR MEDICAL PURPOSE THAT IS WORN ON THE EXAMINER'S HAND OR FINGERS TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.

DISPOSABLE VINYL EXAMINATION GLOVES, YELLOW COLOR POWDER FREE WITH VITAMIN E

This document is a 510(k) clearance letter from the FDA for disposable vinyl examination gloves. It does not contain information on acceptance criteria or a study proving the device meets those criteria. The document only confirms that the device is substantially equivalent to a legally marketed predicate device for its stated indications for use. Therefore, I cannot extract the requested information from the provided text.

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A PATIENT EXAMINATION GLOVE IS A DISPOSABLE DEVICE INTENDED FOR MEDICAL PURPOSE THAT IS WORN ON THE EXAMINER'S HAND OR FINGER TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.

STERILE DISPOSABLE VINYL SYNTHETIC EXAM GLOVES, POWDER FREE

The provided text is related to an FDA 510(k) clearance for "Sterile Disposable Vinyl Synthetic Examination Gloves, Powder Free". This document is a clearance letter and an "Indications for Use" statement, not a study report or clinical trial summary.

Therefore, the input does not contain the necessary information to describe acceptance criteria and a study that proves the device meets those criteria. The provided text does not describe:

• Acceptance criteria for device performance (e.g., burst strength, tensile strength, barrier integrity).
• Any specific study conducted to test the device's performance against such criteria.
• Sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth establishment.

This document is solely an administrative clearance from the FDA, stating that the device is substantially equivalent to legally marketed predicate devices for its stated indications for use. It does not contain the detailed technical or clinical study information required to answer the prompt.

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A PATIENT EXAMINATION GLOVE IS A DISPOSABLE DEVICE INTENDED FOR MEDICAL PURPOSE THAT IS WORN ON THE EXANINER'S HAND OR FINGER TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.

Environ-NP Powder Free Synthetic Vinyl Examination Gloves

I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA 510(k) clearance letter for "Environ-NP Powder Free Synthetic Vinyl Examination Gloves." It discusses the regulatory approval process and includes a general "Indications for Use" statement for patient examination gloves.

However, it does not describe any acceptance criteria, a specific study proving device performance against those criteria, or any details related to AI algorithms, ground truth, sample sizes for training/testing, expert adjudication, or MRMC studies.

Therefore, I cannot generate the table or answer the specific questions related to acceptance criteria and study details based on this document.

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A PATIENT EXAMINATION GLOVE IS A DISPOSABLE DEVICE INTENDED FOR MEDICAL PURPOSE THAT IS WORN ON THE EXAMINER'S HAND OR FINGER TO PREVENT CONTAMINATION BETTERN PATIENT AND EXPMINER.

Environ-NF DISPOSABLE SYNTHETIC VINYL EXAM GLOVE, POWDER FREE (YELLOW)

The provided text is a 510(k) clearance letter from the FDA for a medical device: "Environ-NP Powder Free Synthetic Vinyl Examination Gloves." This document is a regulatory approval and does not contain any information regarding acceptance criteria or a study proving the device meets those criteria in the way a performance study for an AI/ML device would.

The letter confirms that the device is substantially equivalent to legally marketed predicate devices and can therefore be marketed. The "indications for use" simply describe the intended purpose of the gloves (to prevent contamination between patient and examiner).

Therefore, I cannot provide the requested information about acceptance criteria, performance studies, sample sizes, expert qualifications, or ground truth types, as these are not present in the provided text.

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Ask a specific question about this device

A PATIENT EXAMINATION GLOVE IS A DISPOSABLE DEVICE INTENDED FOR MEDICAL PURPOSES WORN ON THE EXAMINER HAND OR FINGER TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.

DISPOSABLE PVC POWDERED SYNTHETIC EXAMINATION GLOVES

This document is a 510(k) clearance letter from the FDA for "DISPOSABLE PVC POWDERED SYNTHETIC EXAMINATION GLOVES." The letter confirms that the device is substantially equivalent to legally marketed predicate devices.

The information provided does not contain details about acceptance criteria, a study proving the device meets those criteria, or any of the specific points requested (sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth details, training set information).

This document is solely an FDA clearance letter for a medical device (examination gloves), indicating that it can be legally marketed. It does not contain the kind of performance data or study details you are asking for, which would typically be found in a separate study report or regulatory submission appendix.

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A PATIENT EXAMINATION GLOVE IS A DISPOSABLE DEVICE INTENDED FOR MEDICAL PURPOSE THAT IS WORN ON THE EXAMINER'S HAND OR FINGER TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.

DISPOSABLE PVC SYNTHETIC EXAMINATION GLOVES, POWDER FREE

This document is a 510(k) premarket notification letter from the FDA regarding "Disposable PVC Synthetic Examination Gloves, Powder Free." It states that the device is substantially equivalent to legally marketed predicate devices.

This document does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria. It is a regulatory clearance document, not a performance study report.

Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and study details. This type of information is typically found in the 510(k) submission itself, which is a much more extensive document than this clearance letter.

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