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A sterile power-free latex surgeon's glove is a disposable device intended for medical purpose that is worn by operating room personnel to protect a surgical wound from contamination.

Sterile Powder-Free Latex Surgical Gloves

Analysis of Device Acceptance Criteria and Study:

The provided documents are a 510(k) clearance letter from the FDA for "Sterile Powder-Free Latex Surgical Gloves" and related forms. This type of FDA clearance relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive clinical studies with specific acceptance criteria in the way a novel AI or diagnostic device would.

Therefore, many of the requested categories for a study that "proves the device meets the acceptance criteria" are not directly applicable to a 510(k) submission for a Class I medical device like surgical gloves. The "acceptance criteria" here are primarily regulatory and performance standards for gloves, not diagnostic metrics.

However, I can extract information relevant to the intent of your questions based on what is typically required for a 510(k) of this nature.

1. Table of Acceptance Criteria and Reported Device Performance:

For surgical gloves, the primary performance criteria revolve around safety, barrier integrity, and physical properties. These are typically assessed against recognized industry standards (e.g., ASTM, ISO). The 510(k) summary (which is not fully provided here but would be part of the submission) would detail the specific tests conducted and their compliance.

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