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A patient examination glove is disposable device intended for mediod purposes that is donned by the user on the hands prevent possible contamination between patient and examiner.

Colored and Flavored Pre-powdered Latex Pattent Examination Gloves , P.ok - Tulli-Feath, Brice - River , Gram - pipero - pipermint , Lives , P. Contains is megro on Tess af Tual City & Charler experiment , States , policings

This document is a 510(k) clearance letter from the FDA for a medical device: Natural Rubber Pre-Powdered Colored and Flavored Patient Examination Gloves.

Based on the provided text, there is no acceptance criteria or study information that proves the device meets specific performance criteria.

Here's why:

• 510(k) Clearance: This is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed predicate device. This process primarily relies on demonstrating equivalence to an existing device, not necessarily on new studies proving specific performance metrics beyond what was established for the predicate.
• "Contains Claim of 150 mcgm or Less of Total Water Extractable Protein Per Gram": This is a claim about the device's composition, specifically regarding its protein content to potentially reduce allergic reactions. While it implies a target, the document does not present any study data demonstrating that this claim was met for the specific device under review. It's a characteristic of the product, not necessarily a performance acceptance criterion in the context of a clinical study or effectiveness study described here.
• Focus of the Letter: The letter's content is entirely administrative, confirming that the device is "substantially equivalent" to predicate devices and can therefore be marketed. It discusses regulatory classes, general controls, and compliance with manufacturing practices. It does not delve into detailed performance studies or their results.

Therefore, I cannot fill out the requested table regarding acceptance criteria and study data using the provided scanned document. The document describes a regulatory clearance based on substantial equivalence, not a detailed performance study.

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The device is a disposable patient examination glove made of synthetic rubber intended for medical purposes. It is donned by the user as protection against possible contamination when examining a patient.

Powderfree Chloroprene Flavored and Colored Patient Examination Gloves

The provided text is a 510(k) premarket notification approval letter for "Powder-Free Colored (White, Pink, Blue Green) and Flavored (Strawberry, Tutti-Fruity and Peppermint) Chloroprene Patient Examination Glove." This document is related to the regulatory approval of a medical device, specifically a patient examination glove.

Medical gloves are designed to prevent contamination and act as a barrier. Their performance is primarily evaluated based on their physical integrity (e.g., freedom from holes) and barrier properties. The provided document does not contain specific acceptance criteria for device performance or the details of a study proving those criteria are met.

The letter states that the device is "substantially equivalent" to legally marketed predicate devices, which means its safety and effectiveness are considered comparable. For devices like gloves, "performance" typically refers to physical properties that ensure their barrier function.

However, based on general knowledge of glove regulatory requirements and what would be typical for a 510(k) submission for such a device, I can infer the types of acceptance criteria and studies that would likely have been submitted.

Inferred Acceptance Criteria and Study (Based on common glove standards and 510(k) requirements):

1. Table of Acceptance Criteria and Reported Device Performance (Inferred):

2. Sample Size Used for the Test Set and Data Provenance (Inferred):

• Sample Size: For AQL testing (e.g., pinholes), sample sizes are typically determined by statistical sampling plans, often involving hundreds or thousands of gloves from specific production lots. For physical property tests, smaller but statistically significant sample sizes (e.g., 5-10 gloves per lot) are common. Biocompatibility studies use animal models (e.g., 5-10 animals per test group) or in vitro cell cultures.
• Data Provenance: Likely retrospective (tests performed on manufactured lots) and conducted by the manufacturer (PT Irama Dinamika Latex in Indonesia) or a contracted testing laboratory. The document explicitly states the manufacturer is from Indonesia.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts (Inferred):

• For physical and chemical tests of gloves, "ground truth" is typically established by standardized laboratory testing procedures performed by certified technicians or engineers in quality control or R&D departments. There isn't typically an "expert consensus" for these types of objective measurements in the same way there would be for image interpretation in radiology. The "experts" are the personnel competent in performing the specified ASTM or EN standard test methods. Their qualifications include training and experience in metrology, materials science, or chemical analysis, often with documented proficiency in the specific test standards.

4. Adjudication Method for the Test Set (Inferred):

• For objective physical, chemical, and biological tests, adjudication is not typically required in the sense of multiple reviewers resolving discrepancies in subjective interpretations. Instead, results are obtained by following a clearly defined standard. If a result is borderline or unexpected, the test may be repeated by the same or different qualified personnel following the same standard, and statistical methods (e.g., for AQL) would determine acceptance or rejection of a lot.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done (Not Applicable):

• No, an MRMC study would not have been done for a patient examination glove. MRMC studies are used for diagnostic devices (e.g., imaging software) to compare the performance of human readers with and without AI assistance on complex cases. A glove is a physical barrier device, not a diagnostic tool requiring human interpretation of information.

6. If a Standalone Study (Algorithm Only) was Done (Not Applicable):

• No, a "standalone" study is not applicable for this device. This refers to the performance of an AI algorithm without human input. A glove is a physical product; there is no embedded algorithm.

7. The Type of Ground Truth Used (Inferred):

• Objective Measurement Data based on Recognized Standards:
  • For physical integrity (pinholes): Determined by water leak test or air inflation test as per ASTM D5151 or EN 455-1.
  • For physical properties (tensile strength, elongation): Determined by mechanical testing equipment as per ASTM D412 or EN 455-2.
  • For biocompatibility: Determined by in vitro (cytotoxicity) and in vivo (sensitization) tests following ISO 10993 series.
  • For chemical residues: Determined by gravimetric or analytical chemistry methods (e.g., for powder residue via ASTM D6124).

8. The Sample Size for the Training Set (Not Applicable):

• Not applicable. This device is a physical product, not an AI/ML algorithm that requires a "training set" of data.

9. How the Ground Truth for the Training Set was Established (Not Applicable):

• Not applicable. As there is no training set for an algorithm, this question is not relevant.

Summary of Device and Approval:

The provided document details the FDA's approval of "Powder-Free Colored and Flavored Chloroprene Patient Examination Gloves" for marketing based on their substantial equivalence to predicate devices. This means that the device is considered safe and effective because it performs at least as well as other legally marketed gloves, likely demonstrated through a battery of standard physical, chemical, and biological tests. However, the specific test results and acceptance criteria are not included in this regulatory letter itself, but would have been part of the manufacturer's 510(k) submission.

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A patient examination glove is a disposable device intended for medical purposes that is donned by doctors and healthcare workers as protection against possible infection/contamination when examining a patient.

Not Found

This document is a 510(k) clearance letter from the FDA for "Hypoallergenic Latex Patient Exam Gloves." It explicitly states that the device is "substantially equivalent" to predicate devices marketed prior to May 28, 1976. This type of clearance does not involve the detailed performance studies or statistical analyses typically required for novel medical devices. The FDA determines substantial equivalence primarily based on comparing the new device's technological characteristics and intended use to a legally marketed predicate device.

Therefore, the requested information regarding acceptance criteria, specific performance studies, sample sizes, expert involvement, and ground truth establishment is not available in this document and is not typically part of a 510(k) notification for devices like examination gloves.

Here's why and what can be inferred:

• Acceptance Criteria & Device Performance: For examination gloves, acceptance criteria relate more to material properties, physical dimensions, leak resistance, tensile strength, and biocompatibility, as defined by recognized standards (e.g., ASTM standards for medical gloves) that ensure they meet their intended protective function. The document confirms the device is a "patient examination glove" and is "hypoallergenic," implying it meets general performance standards for such devices and has been shown not to cause common allergic reactions associated with latex. However, specific numerical acceptance criteria and reported device performance (e.g., specific AQL levels for pinholes) are not detailed in this clearance letter.
• Study That Proves the Device Meets Acceptance Criteria: The "study" for a 510(k) of this nature typically involves demonstrating that the new device meets relevant consensus standards (like ASTM D3577 for rubber examination gloves) and that its hypoallergenic properties are substantiated, often through specific testing (e.g., protein content testing) compared to predicate devices. This isn't a clinical trial in the sense of comparing diagnostic accuracy or clinical outcomes.
• Sample Size, Ground Truth, Experts, Adjudication, MRMC, Standalone Performance, Training Set: These concepts are relevant to software or AI-driven medical devices, or complex diagnostic/therapeutic devices that require extensive clinical validation. For a Class I device like an examination glove, these are generally not applicable. The equivalence is established by comparing technical specifications and performance against recognized standards or an existing predicate device.
• Data Provenance: Not applicable in the context of this device's clearance.
• Type of Ground Truth Used: For gloves, "ground truth" would be objective measurements against material specifications and safety standards (e.g., laboratory tests for protein content, leak resistance, physical dimensions).
• How Ground Truth for Training Set Was Established: Not applicable as a training set for machine learning is not used here.

In summary, this document is a regulatory clearance based on substantial equivalence, not a detailed performance study report. The questions posed are highly relevant for artificial intelligence/machine learning devices or those requiring extensive clinical studies, but not for a Class I device like examination gloves cleared via the 510(k) pathway.

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A patient examination glove is a disposable device intended for medical purposes that is donned by doctors and healthcare workers as protection against possible infection/contamination when examining a patient.

Powderfree Colored and Flavored Nitrile Copolymer Patient Examination Gloves.

The provided document is a 510(k) premarket notification letter from the FDA regarding "Powderfree Colored and Flavored Nitrile Copolymer Patient Examination Gloves." This document is a regulatory approval letter and does not contain any information about the acceptance criteria or a study proving the device meets those criteria, nor does it discuss AI or performance metrics typical of studies proving device effectiveness.

The document primarily states that the FDA has reviewed the 510(k) submission and determined the device is substantially equivalent to legally marketed predicate devices. It covers administrative aspects such as classification, general controls, and compliance with regulations.

Therefore, I cannot provide the requested information based on the content of this document.

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