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

Powder Free Latex Examination Gloves (Vanilla Flavor)

This document is a 510(k) clearance letter from the FDA for "Powder-Free Latex Examination Gloves, Trade Name: Vanilla Flavor." It is not a study report or technical document detailing acceptance criteria and performance data for a device.

Therefore, I cannot extract the acceptance criteria and study information you requested because this document does not contain that level of detail.

The letter confirms that the device is "substantially equivalent" to legally marketed predicate devices. This means that the FDA has determined it is as safe and effective as a previously cleared device. However, the clearance letter itself does not provide the specific performance data, test methods, or acceptance criteria that were used to establish this substantial equivalence.

To answer your questions, you would typically need a more detailed submission document (e.g., the 510(k) submission itself or a summary of its contents) which would include:

• Performance Standards: Often, medical devices are cleared based on compliance with recognized consensus standards (e.g., ASTM standards for gloves). These standards would define the acceptance criteria for properties like tensile strength, elongation, barrier integrity (pinhole rate), and biocompatibility.
• Test Data: Results from studies (e.g., physical property testing, biocompatibility testing) demonstrating that the device meets those standards.

Without that specific technical information, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them.

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