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A medical glove is worn on the hand of healthcare and similiar personnel to prevent contamination between healthcare personnel and patient

POWDERED NITRILE EXAMINATION GLOVES

This document is a 510(k) clearance letter from the FDA for Powdered Nitrile Examination Gloves. It does not contain information about acceptance criteria or a study proving the device meets those criteria, as it's a regulatory approval based on substantial equivalence to a predicate device, not a performance study report.

Therefore, I cannot provide the requested information based on the provided text. The document primarily states that the device is substantially equivalent to legally marketed predicate devices and outlines regulatory responsibilities.

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A medical glove is worn on the hand of healthcare and similar personnel to prevent contamination between health care personnel and patient. It is a single use disposable gloves.

Powdered Latex Examination Gloves

This document is a 510(k) premarket notification approval letter for Powdered Latex Examination Gloves manufactured by Servicom Services Sdn. Bhd. It does not contain information about the acceptance criteria or a study proving device performance as typically expected for medical AI/imaging devices.

Therefore, I cannot extract the requested information. The document is an FDA approval for a physical medical device (gloves), not a software or AI device that would undergo such testing and reporting in a 510(k) submission.

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A medical glove is worn on the hand of healthcare and similar personnel to prevent contamination between health care personnel and patient. It is a single use disposable gloves.

Powderfree Latex Examination Gloves with Trade Name: Protein Content Labeling Claim (50 Micrograms of Less)

This document is a 510(k) clearance letter from the FDA for "Powderfree Latex Examination Gloves with Trade Name: Protein Content Labeling Claim (50 Micrograms of Less)" manufactured by Servicom Services Sdn. Bhd. It does not contain the detailed information necessary to answer the questions about acceptance criteria for a medical device's performance study.

The letter acknowledges the submission and states that the device is substantially equivalent to a legally marketed predicate device. The "Indications For Use" attachment specifies that the medical glove is used to prevent contamination between healthcare personnel and patients, and that it is a single-use disposable glove.

The document does not include:

1. A table of acceptance criteria or reported device performance.
2. Sample size, data provenance, or details of a test set.
3. Information on experts or ground truth establishment.
4. Adjudication methods.
5. Details of a multi-reader multi-case (MRMC) comparative effectiveness study, as it's not relevant for this type of device.
6. Information on standalone algorithm performance (as it's not an algorithmic device).
7. The type of ground truth used (as it's not an AI/diagnostic device).
8. Sample size for a training set (as it's not an AI/diagnostic device).
9. How ground truth for a training set was established (as it's not an AI/diagnostic device).

Therefore, I cannot provide the requested information based on the provided text.

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