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Non-chlorinated Power Free Natural Rubber Examination Glove is a single use device intended for medical purposes that is worn on the hand of the healthcare and similar personnel to prevent contamination between the healthcare personnel and the patient.

Non-Chlorinated, Polymer Coated, Powder Free Natural Rubber Latex Examination Glove

The provided text is a 510(k) premarket notification letter from the FDA regarding a Latexx Manufacturing Non-Chlorinated, Polymer Coated, Powder Free Natural Rubber Latex Examination Glove. This document does not contain information about acceptance criteria for a device's performance, nor does it describe a study proving the device meets such criteria.

The letter primarily:

• Confirms the FDA's review of the 510(k) submission (K014087).
• States that the device is substantially equivalent to legally marketed predicate devices.
• Informs the manufacturer that they can market the device subject to general controls.
• Outlines general regulatory compliance requirements.
• Provides contact information for further guidance.
• Includes a separate "Indications for Use" statement, which defines the intended purpose of the device.

Therefore, I cannot provide the requested information. The document does not describe:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance for a test set.
3. Number or qualifications of experts for ground truth establishment.
4. Adjudication methods.
5. MRMC comparative effectiveness study results.
6. Standalone (algorithm-only) performance.
7. Type of ground truth used in a study.
8. Sample size for a training set.
9. How ground truth for a training set was established.

This document is a regulatory clearance letter, not a performance study report.

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