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A medical examination glove is worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient.

Powdered Nitrile Examination Gloves

The provided text is a 510(k) Pre-market Notification from the FDA concerning "Powdered Nitrile Examination Gloves." This type of document is a regulatory approval for a medical device that demonstrates substantial equivalence to a legally marketed predicate device.

Crucially, this document does not contain information about specific acceptance criteria or a study proving the device meets those criteria in the way you've outlined for AI/diagnostic devices.

Here's why and what information can be extracted:

• Device Type: Examination gloves are Class I medical devices (Product Code: LZA). For these devices, the regulatory pathway (510(k)) primarily focuses on demonstrating "substantial equivalence" to a predicate device, meaning it's as safe and effective as a device already on the market.
• No Performance Study Details: The letter acknowledges the submission and states that the device is "substantially equivalent." It doesn't present technical performance metrics, sensitivity, specificity, or reader studies because these are not typically required for this class of device or at this stage of the 510(k) process for a physical, low-risk product like a glove. The "study" mentioned would have been internal testing by the manufacturer to show the glove meets its intended purpose (e.g., integrity, strength, biocompatibility), but the details of that study are not in this FDA letter.
• "Acceptance Criteria" for a Glove: For gloves, "acceptance criteria" likely refer to standards for tensile strength, elongation, puncture resistance, barrier properties, freedom from holes, and biocompatibility, as outlined in recognized industry standards (e.g., ASTM D6319 for nitrile examination gloves). The letter implies that Supermax Glove Manufacturing Sdn. Bhd. provided data demonstrating compliance with these types of standards in their original 510(k) submission, leading to the substantial equivalence determination.

Therefore, I cannot fill out your requested table and study details based on the provided document.

Here’s an explanation of why each of your requested points cannot be addressed by this document:

1. A table of acceptance criteria and the reported device performance: Not present. The letter confirms "substantial equivalence" but doesn't list specific performance metrics.
2. Sample size used for the test set and the data provenance: Not present. This information would be in the manufacturer's submission, not the FDA's approval letter.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not present. This concept (experts establishing ground truth) is more relevant to diagnostic interpretations, not physical product testing for gloves.
4. Adjudication method: Not applicable/present.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable/present. This is for diagnostic interpretation, not product physical properties.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable/present. This is for AI/software, not a physical glove.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable/present in this context. For gloves, 'ground truth' would be objective physical and chemical test results based on established standards.
8. The sample size for the training set: Not applicable/present. This refers to AI model training.
9. How the ground truth for the training set was established: Not applicable/present.

In summary, this document is a regulatory approval for a low-risk medical device (exam gloves) based on substantial equivalence, and it does not contain the detailed performance study information typically required for high-risk diagnostic devices or AI algorithms.

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