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A patient examination Nitrile Blue Powdered Glove is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.

Master Guard Disposable Nitrile Powdered Blue Examination Gloves

This FDA 510(k) clearance letter for "Master Guard Disposable Nitrile Powdered Blue Examination Gloves" does not contain the detailed information necessary to describe acceptance criteria and a study proving device performance in the way requested.

The letter primarily focuses on the regulatory determination of substantial equivalence to a predicate device, which means the device is considered as safe and effective as a legally marketed device that was on the market prior to May 28, 1976.

Specifically, the document does not provide any information for the following requested items:

1. A table of acceptance criteria and the reported device performance: This type of data is typically found in a summary of safety and effectiveness or a test report, not in the clearance letter itself.
2. Sample size used for the test set and the data provenance: There is no mention of specific test sets or their size/origin.
3. Number of experts used to establish the ground truth for the test set and the qualifications: Not applicable, as no such test is described.
4. Adjudication method: Not applicable.
5. Multi reader multi case (MRMC) comparative effectiveness study: Not applicable.
6. Standalone (i.e. algorithm only without human-in-the-loop performance) study: Not applicable (this is a physical glove, not an AI algorithm).
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable (this is a physical glove, not an AI algorithm).
9. How the ground truth for the training set was established: Not applicable.

The document does state the Indications for Use:
"A patient examination Nitrile Blue Powdered Glove is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner."

To find information on acceptance criteria and performance data for this type of device, one would typically need to refer to:

• Voluntary consensus standards: Such as ASTM standards for medical examination gloves (e.g., ASTM D6319 for nitrile examination gloves), which define performance requirements for properties like tensile strength, elongation, puncture resistance, and barrier integrity (e.g., AQL for pinholes).
• The 510(k) submission itself: The actual submission would contain the test reports and data that demonstrate the device meets these standards and any other specific performance claims, enabling the FDA to determine substantial equivalence.

Without access to the actual 510(k) submission, the requested information cannot be extracted from the provided text.

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A patient examination Nitrile Blue Powdered Glove is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.

Nitrile Blue Powdered Examination Glove

The provided document is a 510(k) premarket notification letter from the FDA for a Nitrile Blue Powdered Examination Glove. It is a regulatory document affirming equivalence to a predicate device and does not contain information about acceptance criteria or performance studies as typically described for a medical device that relies on algorithmic or diagnostic performance.

Therefore, I cannot answer your request regarding acceptance criteria and device performance studies because the information is not present in the provided text. The document is about a physical medical device (examination glove) that falls under general controls and does not involve AI or complex performance metrics as implied by your questions.

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A patient examination Nitrile Blue Powdered Glove is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.

Powdered Nitrile Blue Examination Gloves

The provided text is a 510(k) premarket notification letter from the FDA for Powdered Nitrile Blue Examination Gloves. This document is for a medical device that falls under Class I (general controls) and is determined to be substantially equivalent to existing predicate devices.

Crucially, this type of FDA document for a Class I general control device like examination gloves does NOT contain the kind of detailed clinical study information requested in your prompt.

The questions you've asked (about acceptance criteria, specific study designs like MRMC, sample sizes, ground truth establishment, expert qualifications, etc.) are typically associated with higher-risk medical devices (Class II with Special Controls or Class III PMA devices) that require more robust clinical evidence to demonstrate safety and effectiveness.

For Class I devices like examination gloves, "acceptance criteria" primarily relate to performance standards (e.g., tear resistance, barrier integrity, biocompatibility, dimensions) which are usually met through bench testing and adherence to recognized consensus standards (like ASTM standards for medical gloves) during manufacturing. The "study" proving these criteria are met would be these bench tests, not clinical trials in the way you're describing.

Therefore, I cannot provide answers to your specific questions based on the provided document. The document confirms the device's classification, its intended use, and its substantial equivalence to a predicate, but does not detail a clinical study with elements like expert adjudication or MRMC analysis.

However, if we were to infer what "acceptance criteria" and "study" would look like for such a device, it would generally involve:

• Acceptance Criteria (hypothetical, based on common glove standards):
  • Barrier Integrity (e.g., AQL for pinholes): A certain Acceptable Quality Level (AQL) for pinholes (e.g., 2.5% for general purpose, 1.5% for surgical)
  • Tensile Strength & Elongation: Meeting minimum breaking strength and elongation percentages before break.
  • Dimensions: Conforming to specified length, palm width, and finger thickness.
  • Powder Residue (if powdered): Below a specified limit (though this device is "Powdered Nitrile Blue" meaning it likely contains powder, but standards might set a max acceptable level or require specific labeling).
  • Biocompatibility: Non-irritating, non-sensitizing (tested via ISO 10993 standards).
  • Freedom from hazardous substances: Compliance with relevant regulations for restricted substances.
• "Study" to prove criteria conformance (hypothetical):
  • Bench Testing: Lot-by-lot or sampling-based testing for AQL (water leak test for pinholes), tensile properties, dimensions, and powder content.
  • Biocompatibility Testing: In vitro or in vivo tests (e.g., cytotoxicity, irritation, sensitization assays) to ISO 10993 standards.

None of these details, however, are present in the provided FDA letter.

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