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The Medical Nitrile Examination Glove is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner.

The subject device is powder free nitrile examination gloves. The subject device is blue. It can be available in six specifications: S,M,L,XL. The subject device is non-sterile.

The provided text describes the 510(k) summary for the "Medical Nitrile Examination Gloves" (K220066). This document is for a Class I medical device (non-powdered patient examination glove), which is a low-risk device. For such devices, clinical testing is typically not required, and the focus of the submission is on non-clinical performance and substantial equivalence to a predicate device.

Therefore, the requested information regarding AI device performance, sample sizes for test sets, ground truth establishment, expert adjudication, MRMC studies, and standalone algorithm performance does not apply to this specific submission. This document details the testing of physical properties and biocompatibility of examination gloves, not an AI or imaging device.

However, I can extract the acceptance criteria and performance data for the glove product based on the provided non-clinical testing summary.

Here's the relevant information based on the document:

1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical, for Medical Nitrile Examination Gloves)

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Medical Surgical Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. It is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device(s), provided as sterile.

The Medical Surgical Mask is single use, three-layer, flat-pleated style with ear loops and nose piece. The Medical Surgical Mask is manufactured with three layers, the inner and outer layers are made of polypropylene, and the middle layer is made of melt blown polypropylene filter. The ear loops are held in place over the users' mouth and nose by two elastic ear loops welded to the facemask. The elastic ear loops are not made with natural rubber latex. The nose piece in the lavers of facemask is to allow the user to fit the facemask around their nose. which is made of Galvanized iron wire. The Medical Surgical Mask will be provided in blue. The Medical Surgical Mask is sold as sterile and are intended to be single use, disposable devices.

Here's a breakdown of the acceptance criteria and study information for the "Medical Surgical Mask" based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

• Lot 1: 31 Out of 32 pass at 160mmHg (21.3 kPa)
• Lot 2: 31 Out of 32 pass at 160mmHg (21.3 kPa)
• Lot 3: 32 Out of 32 pass at 160mmHg (21.3 kPa) |
  | Particulate Filtration Efficiency ASTM F2299 | Evaluate the Particulate Filtration Efficiency | ≥ 98% | Pass
• Lot 1: 99.02%-99.58%
• Lot 2: 99.05%-99.59%
• Lot 3: 99.10%-99.68% |
  | Bacterial Filtration Efficiency ASTM F2101 | Evaluate the Bacterial Filtration Efficiency | ≥ 98% | Pass
• Lot 1: 98.8%-99.7%
• Lot 2: 98.7%-99.5%
• Lot 3: 98.9%-99.5% |
  | Differential Pressure (Delta P) MIL-M-36954C | Evaluate the Differential Pressure (Delta P) |

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