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A patient examination glove is a disposable device intended for medical purposes worn on the examiner's hand to prevent contamination between patient and examiner.

Extra-Care Latex Powder-Free Examination Glove

The provided text does not contain information about acceptance criteria or a study proving that the device meets those criteria. This document is a 510(k) clearance letter from the FDA for a medical device, specifically "Extra-Care Latex Powder-Free Examination Glove."

The letter confirms that the device is substantially equivalent to legally-marketed predicate devices, allowing it to be marketed. It discusses regulatory classifications, general controls, and compliance with manufacturing practices.

Here's why the requested information cannot be extracted from this document:

• Acceptance Criteria/Performance Data: The letter focuses on regulatory approval based on "substantial equivalence" to a predicate device, not on specific performance metrics or acceptance criteria for the new device itself. It doesn't present any test results or performance tables.
• Study Details: There is no mention of any specific study conducted by the applicant (Ultrawin Sdn. Bhd.) to demonstrate performance, including:
  • Sample size or data provenance.
  • Details about experts or ground truth establishment.
  • Adjudication methods.
  • MRMC studies or effect sizes.
  • Standalone algorithm performance.
  • Ground truth types.
  • Training set details.

The "Indications for Use Statement" section defines what the device is (a disposable glove for medical purposes) and its intended use (to prevent contamination between patient and examiner), but it does not specify any performance standards or criteria that the glove must meet beyond general safety and effectiveness implied by the regulatory clearance.

Therefore, I cannot populate the requested table or provide answers to the specific study-related questions based on the input text.

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