(267 days)
The nitrile examination gloves is a disposable device intended for medical and dental purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
Blue Powder Free Nitrile Examination Gloves
This document is a 510(k) premarket notification letter from the FDA regarding "Blue Powder Free Nitrile Examination Gloves." It does not contain information about the acceptance criteria or a study that proves the device meets those criteria in the way a performance study for an AI/ML medical device would.
The document establishes that the device is "substantially equivalent" to legally marketed predicate devices, meaning it has the same intended use and technological characteristics as a device already on the market, or has different technological characteristics but does not raise different questions of safety and effectiveness.
For a medical device like examination gloves, the "acceptance criteria" are typically defined by recognized standards related to performance attributes such as barrier integrity (e.g., freedom from holes), tensile strength, and dimensions. The "study" would refer to testing performed by the manufacturer to demonstrate compliance with these standards.
Here's how I can address your request based on the absence of the specific information you're looking for in this type of FDA letter:
Acceptance Criteria and Device Performance Study for "Blue Powder Free Nitrile Examination Gloves"
Based on the provided FDA 510(k) premarket notification letter (K052583), the detailed acceptance criteria and the comprehensive study proving the device meets these criteria, as expected for an AI/ML device, are not explicitly present within this document.
For examination gloves, the "acceptance criteria" are generally derived from established consensus standards (e.g., ASTM, ISO) that define the performance and safety requirements for such devices. The "study" would typically involve laboratory testing. The FDA's substantial equivalence determination for this type of device relies on the manufacturer demonstrating that their device meets these recognized standards, often through bench testing.
However, if we were to infer the types of criteria and studies usually associated with examination gloves, and then report what this document provides, it would look like this:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric (Hypothetical for Gloves) | Acceptance Criterion (Hypothetical Standard) | Reported Device Performance (Inferred from 510(k)) |
|---|---|---|
| Freedom from holes (water leak test) | AQL 2.5 (e.g., ASTM D5151) | Implied compliance for substantial equivalence |
| Tensile Strength before aging | Standard minimum (e.g., ASTM D412) | Implied compliance for substantial equivalence |
| Tensile Strength after aging | Standard minimum (e.g., ASTM D573) | Implied compliance for substantial equivalence |
| Elongation before aging | Standard minimum (e.g., ASTM D412) | Implied compliance for substantial equivalence |
| Elongation after aging | Standard minimum (e.g., ASTM D573) | Implied compliance for substantial equivalence |
| Powder Residue | Max limit (e.g., ASTM D6124) | Implied compliance for substantial equivalence |
| Dimensions (length, width, thickness) | Standard range (e.g., ASTM D6319) | Implied compliance for substantial equivalence |
| Biocompatibility (e.g., skin irritation) | ISO 10993 series | Implied compliance for substantial equivalence |
Explanation: The FDA letter states the device is "substantially equivalent" to predicate devices. This implies that the manufacturer, Hartalega Sdn. Bhd., submitted data to the FDA demonstrating that their Blue Powder Free Nitrile Examination Gloves meet the performance specifications (e.g., physical properties, barrier integrity, biocompatibility) typically required for patient examination gloves and defined in recognized consensus standards (like ASTM D6319 for Nitrile Examination Gloves) and/or previously cleared predicate devices. The specific test results are not detailed in this public brief.
2. Sample size used for the test set and the data provenance
The document does not specify the sample sizes used for performance testing (e.g., for freedom from holes, tensile strength) or the data provenance (e.g., country of origin, retrospective/prospective). For gloves, sampling is typically done according to relevant ASTM or ISO standards from manufacturing lots.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This type of information is not relevant or applicable for the regulatory review of physical examination gloves. "Ground truth" in the context of examination gloves refers to objective physical and chemical measurements rather than expert human interpretation.
4. Adjudication method for the test set
Not applicable for objective physical and chemical testing of examination gloves.
5. 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 an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML device.
7. The type of ground truth used
For examination gloves, the "ground truth" is established through objective, quantifiable laboratory tests following recognized standards. Examples include:
- Physical measurements: Using calipers for thickness, rulers for length, etc.
- Chemical tests: Using analytical methods for powder residue.
- Mechanical tests: Using tensile testers for strength and elongation.
- Barrier integrity tests: Water leak tests or air inflation tests.
- Biocompatibility tests: In vitro or in vivo tests following ISO 10993 standards.
8. The sample size for the training set
Not applicable. This is not an AI/ML device and therefore does not have a "training set" in that context.
9. How the ground truth for the training set was established
Not applicable. As this is a physical medical device (examination gloves), concepts like "training set" and "ground truth establishment" via expert consensus are not relevant to its regulatory review process for substantial equivalence. The "ground truth" for its performance is derived from standardized laboratory testing.
§ 880.6250 Non-powdered patient examination glove.
(a)
Identification. A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.(b)
Classification. Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.