Search Results

Sterile Powder Free Nittile Examination Gloves (Blue, Black and White Colors) is a disposable device intended for medical purposed that is worn on the examiner's hand to prevent contamination between patient and examiner.

Sterile Powder Free Nitrile Examination Gloves (Blue, Black &White Colors)

The provided text is an FDA 510(k) clearance letter for "Sterile Powder Free Nitrile Examination Gloves." This document does not contain information about acceptance criteria or a study proving that a device (in the context of an AI/software medical device) meets acceptance criteria.

The information you've requested typically applies to AI/ML (Artificial Intelligence/Machine Learning) or diagnostic medical devices that require performance evaluation against specific metrics (e.g., sensitivity, specificity, AUC). General medical devices like examination gloves are cleared based on substantial equivalence to predicate devices and meeting established performance standards (e.g., standards for tensile strength, barrier integrity, biocompatibility, sterility) through laboratory testing, not through clinical or reader studies that involve humans interacting with an AI or interpreting medical images.

Therefore, I cannot fulfill your request using the provided text. The document is strictly about the regulatory clearance of a physical medical device (gloves) and does not describe the kind of performance study you are asking about.

Ask a specific question about this device

Sterile Surgical Powder Free Latex Glove is a disposable device intended for medical purposed that is worn on by operating room personnel to protect a surgical wound from contamination.

Sterile Surgical Powder Free Latex Glove

I am sorry, but the provided text does not contain information about the acceptance criteria or a study proving that a device meets those criteria. The document is an FDA 510(k) clearance letter for a "Sterile Surgical Powder Free Latex Glove," indicating that the device has been found substantially equivalent to a predicate device.

The information primarily consists of:

• FDA 510(k) Clearance Details: Device name, applicant, regulation number, product code, and clearance date.
• Regulatory Information: References to general controls, other regulations (like registration, labeling, medical device reporting), and contact information for FDA assistance.
• Indications for Use: A description of how the surgical glove is intended to be used.

There is no mention of specific acceptance criteria, performance metrics, study designs, sample sizes, ground truth establishment, or expert qualifications as requested in your prompt.

Ask a specific question about this device

Non Sterile Powder Free Latex Examination Gloves is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.

Non Sterile Powder Free Latex Examination Gloves

The provided document is a 510(k) clearance letter from the FDA for "Non Sterile Powder Free Latex Examination Gloves." It certifies that the device is substantially equivalent to legally marketed predicate devices.

However, the document does not contain any information about acceptance criteria, device performance studies, sample sizes, expert ground truth establishment, or any details related to AI/software performance as requested in your prompt.

The questions you've asked are typically relevant to the evaluation of AI/ML-driven medical devices (e.g., for diagnostic imaging), where performance metrics like sensitivity, specificity, or AUC are critical, and detailed study methodologies are required to demonstrate clinical validity.

This document pertains to a Class I medical device (non-powdered patient examination glove) which is a physical product, not a software or AI-based device. Therefore, the type of information you are seeking (AI performance, MRMC studies, ground truth establishment for algorithms, etc.) is not applicable and not present in this document.

Ask a specific question about this device