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The B-Care Powdered Latex Examination Glove is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.

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I am sorry, but based on the provided text, I cannot provide the detailed information requested regarding acceptance criteria and a study proving device performance. The document is an FDA 510(k) clearance letter for "B-Care Powdered Latex Examination Gloves."

This letter primarily:

• Confirms substantial equivalence: It states that the device is substantially equivalent to legally marketed predicate devices, meaning it has the same intended use and technological characteristics as a device already on the market, or if there are differences, an FDA review showed that the new device is as safe and effective as the predicate.
• Identifies the device and its indications for use: It clearly names the device and its intended purpose.
• Outlines regulatory compliance: It advises the manufacturer on ongoing regulatory requirements.

The document does not include:

• Specific acceptance criteria for device performance (e.g., tensile strength, puncture resistance, barrier integrity).
• Details of a study conducted to demonstrate that the device meets such criteria.
• Information on sample sizes for test sets, data provenance, expert qualifications, or ground truth establishment.
• Any mention of MRMC studies or standalone algorithm performance, as these gloves are a physical medical device, not an AI/software device.

To obtain the information you're looking for, you would generally need to refer to the 510(k) submission itself (which would contain the detailed test reports and methodologies) or potentially standards referenced within such a submission (e.g., ASTM standards for glove performance). The clearance letter only announces the outcome of the FDA's review.

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