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Powder Free Viny! Patient Examination Gloves, Clear (Non-colored) is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Powder Free Vinyl Patient Examination Gloves, Clear (Non-colored) that meets all of the requirements of ASTM standard D 5250-06(Reaffirmation 2011). PVC films form a barrier to body fluids and bloodborne Pathogens. The PVC rubber is water tight under normal conditions of use. It's tensile properties cause it to conform to the hand, allowing movements necessary for a medical procedure. PVC gloves are known to create a barrier to bloodborne pathogens and body fluids. ASTM conforming tensile properties create a glove that is strong and flexible. The glove is manufactured in accordance with the requirements of ASTM D5250 and ASTM D5151 requirements.

The provided text is a 510(k) summary for "Powder Free Vinyl Patient Examination Gloves, Clear (Non-colored)." This type of regulatory submission demonstrates substantial equivalence to a predicate device, rather than proving that a device meets specific acceptance criteria through a study with the detailed elements requested.

Therefore, many of the requested categories for acceptance criteria and study details are not applicable in this context. The submission focuses on demonstrating that the new device has technological characteristics and performance that are equivalent to a legally marketed predicate device and complies with recognized standards.

Here's the information that can be extracted and a clear indication of what is not applicable:

Acceptance Criteria and Device Performance

Study Details

1. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

   • Sample Size for Test Set: Not explicitly stated as a separate "test set" in the context of a diagnostic test study. For the physical and biocompatibility testing (e.g., pinholes, tensile strength, residual powder, skin irritation), samples of the manufactured gloves would have been used. The exact number of units tested for each standard is not provided in this summary.
   • Data Provenance: The manufacturing company is Friend Plastic Co., Ltd. in Shijiazhuang, China. The testing would presumably have been conducted in China or by a certified lab. The summary doesn't specify if the underlying testing data is prospective or retrospective, but it would have been generated specifically for this submission.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

   • Not applicable. This device is a Class I medical device (patient examination gloves) and does not involve the interpretation of medical images or diagnostic outputs that would require expert-established ground truth in the way a diagnostic AI device would. Compliance is determined by objective measurements against established ASTM and ISO standards.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • Not applicable. See point 2.

4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • Not applicable. This is not a diagnostic AI device.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • Not applicable. This is not a diagnostic AI device. The "performance" of the device is its physical and chemical properties.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

   • Objective Measurement against Standards. The "ground truth" for this device's performance is objective measurements (e.g., length, width, thickness, tensile strength, elongation, residual powder, pinhole count) that meet predefined thresholds and specifications outlined in the referenced ASTM and ISO standards (e.g., ASTM D5250, ASTM D5151, ASTM D6124, ISO 10993-10) and regulatory requirements (21 CFR 800.20). Biocompatibility results (non-irritant, non-sensitizer) are also based on validated test methods.

7. The sample size for the training set:

   • Not applicable. This is not a machine learning or AI device that requires a training set. The device is manufactured using a known process, and samples are tested for quality control and regulatory compliance.

8. How the ground truth for the training set was established:

   • Not applicable. See point 7.

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