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

Sterile Powder Free Latex Surgical Gloves with Polymer Coating

This document is a 510(k) clearance letter from the FDA for "Sterile Powder Free Latex Surgical Gloves with Polymer Coating." The information provided in this document does not contain details about specific acceptance criteria, study methodologies, or performance data as requested.

The letter confirms that the device is substantially equivalent to legally marketed predicate devices and outlines general regulatory compliance requirements. It does not include:

• A table of acceptance criteria and reported device performance.
• Sample sizes or data provenance for test sets.
• Information on experts for ground truth establishment.
• Adjudication methods.
• Multi-reader multi-case (MRMC) comparative effectiveness study results.
• Standalone algorithm performance.
• Type of ground truth used.
• Sample size or ground truth establishment for the training set.

These details would typically be found in the 510(k) submission itself (the "premarket notification"), which is a more extensive technical document, rather than in the FDA's clearance letter. The letter primarily states the FDA's decision regarding substantial equivalence based on the submitted information.

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

Sterile Powder Free Synthetic Surgical Gloves with Polymer Coating

The provided text is a 510(k) premarket notification letter from the FDA regarding "Sterile Powder Free Synthetic Surgical Gloves with Polymer Coating." This document, while an important part of medical device regulation, does not contain the acceptance criteria or a study outlining device performance as requested.

The letter focuses on:

• Substantial Equivalence Determination: The FDA has determined the device is substantially equivalent to legally marketed predicate devices.
• Regulatory Classification: The device is classified as Class I (Surgeon's Glove) under regulation number 880.4460, product code KGO.
• Regulatory Requirements: It outlines the general controls provisions of the Act that the device must comply with (e.g., annual registration, listing, good manufacturing practice, labeling, prohibitions against misbranding and adulteration).
• Indications for Use: The glove is indicated for use by healthcare and similar personnel to prevent contamination between personnel and the patient.

Because the document is a regulatory approval letter and not a study report, it does not provide the specific information requested in your prompt regarding acceptance criteria, study design, sample sizes, expert qualifications, or ground truth establishment.

Therefore, I cannot populate the table or answer the specific questions about a study from the given text.

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