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A patient examination glove is worn on the hand of healthcare and similar personnel to prevent containination between healthcare personnel and the patient

Powder Free Latex Examination Gloves, Non-Sterile, Polymer Coated WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)

This document is a 510(k) clearance letter from the FDA for "Powder Free Latex Examination Gloves, Polymer Coated With Protein Content Labeling Claim (50 Micrograms or Less)" by Biografik (Malaysia) Sdn. Bhd.

The document does not contain details about specific acceptance criteria and a study proving the device meets those criteria in the way a medical device software or AI algorithm would. Instead, it states that the device is "substantially equivalent" to legally marketed predicate devices.

Therefore, I cannot provide the requested information, such as a table of acceptance criteria, sample sizes, expert qualifications, or details about standalone or MRMC studies, because this type of information is not typically part of a 510(k) clearance for a product like examination gloves. The regulatory pathway for examination gloves focuses on demonstrating substantial equivalence to existing devices, primarily through material properties, performance standards (e.g., integrity, barrier protection, protein content), and labeling, rather than an "algorithm performance" study as implied by the prompts.

The key information from the document related to claims and regulatory aspects is:

• Device Name: Powder Free Latex Examination Gloves, Non-Sterile, Polymer Coated WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
• 510(k) Number: K993529
• Indication for Use: "A patient examination glove is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient."
• Protein Content Labeling Claim: 50 Micrograms or Less (This could be interpreted as a performance characteristic that would have acceptance criteria for the latex material itself, but the document does not detail the study for this. It's a claim about the product's characteristic, not an AI performance metric.)
• Regulatory Class: I
• Product Code: LYY
• Determination: Substantially Equivalent to devices marketed prior to May 28, 1976.

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