Search Results

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

DISPOSABLE VINYL SYNTHETIC EXAM GLOVES, POWDER FREE

The provided text is a 510(k) substantial equivalence determination letter from the FDA for "Disposable Vinyl Synthetic Examination Gloves, Powder Free". This document is a regulatory approval and does not contain information about acceptance criteria or a study proving that a device meets those criteria for software or AI medical devices.

The document discusses:

• The device name and its regulatory classification.
• The FDA's determination that the device is substantially equivalent to a legally marketed predicate device.
• General controls and requirements under the Federal Food, Drug, and Cosmetic Act.
• Indications for Use for the gloves (to prevent contamination between patient and examiner).

Therefore, I cannot extract the requested information as it is not present in the provided text. The questions posed pertain to the analytical validation of AI/ML or complex diagnostics, which is a different type of submission and data than what is found in this specific 510(k) clearance letter for examination gloves.

Ask a specific question about this device

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

DISPOSABLE VINYL SYNTHETIC EXAM GLOVES, POWDER FREE

The provided text is a 510(k) premarket notification letter from the FDA regarding "Disposable Vinyl Synthetic Exam Gloves, Powder Free." This document is a regulatory approval letter and does not contain information about acceptance criteria or a study proving a device's performance in the context of AI, medical imaging, or diagnostic accuracy.

The device in question is a pair of examination gloves, and the approval is based on substantial equivalence to a predicate device, not on a performance study comparing the device to specific acceptance criteria.

Therefore, I cannot provide the requested information about acceptance criteria or a performance study from this document. The questions posed are related to the evaluation of AI/software as a medical device, which is not applicable to the product described in the provided text.

Ask a specific question about this device

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

DISPOSABLE VINYL SYNTHETIC EXAM GLOVES, POWDER FREE

I apologize, but the provided text from the FDA letter (K990117) does not contain any information about acceptance criteria, device performance metrics, or study details.

This document is a 510(k) clearance letter for "Disposable Vinyl Synthetic Exam Gloves, Powder-Free." It states that the device is "substantially equivalent" to predicate devices marketed before May 28, 1976. The letter primarily addresses:

• Device Identification: Disposable Vinyl Synthetic Exam Gloves, Powder-Free.
• Regulatory Classification: Class I, Product Code LYZ.
• Regulatory Pathway: 510(k) clearance based on substantial equivalence.
• Indications for Use: "A patient examination glove is a disposable device intended for medical purposes worn on the examiner's hand or finger to prevent contamination between patient and examiner."
• General Controls: Mentions requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
• No clinical study data or performance metrics are detailed in this document.

Therefore, I cannot fulfill your request for:

1. Table of acceptance criteria and reported device performance: Not present.
2. Sample sizes, data provenance: Not present for performance testing.
3. Number of experts, qualifications: Not applicable, as no expert review of performance data is mentioned.
4. Adjudication method: Not applicable.
5. MRMC comparative effectiveness study: Not present.
6. Standalone performance: Not present for this type of device and clearance.
7. Type of ground truth: Not applicable.
8. Training set sample size: Not applicable.
9. Ground truth for training set: Not applicable.

This document serves as regulatory clearance based on substantial equivalence, not as a detailed clinical study report or performance validation.

Ask a specific question about this device

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 VINYL SYNTHETIC EXAM GLOVES, POWDER FREE

This document is a 510(k) clearance letter from the FDA for "Disposable Vinyl Synthetic Medical Gloves, Powder-Free" (K982704). It confirms the device is substantially equivalent to legally marketed predicate devices.

The document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or MRMC comparative effectiveness studies. These types of details are not typically included in an FDA clearance letter, which primarily focuses on regulatory approval and substantial equivalence.

Therefore, I cannot provide the requested information from the given text.

Ask a specific question about this device