(172 days)
The N-DEX® BWC™ Pink Nitrile Powder-Free Medical Examination Glove is a disposable device intended for medical purposes; that is worn on the examiner's hand, to prevent contamination between the patient and examiner. (21 CFR 880.6250)
This device has been tested for use with specific chemotherapy drugs. This device is not intended to be used as a chemical barrier.
The N-DEX® BWC™ Nitrile Powder-Free Medical Examination Glove is a disposable device intended for medical purposes; that is worn on the examiner's hand, to prevent contamination between the patient and examiner.
This 510(k) submission describes the N-DEX® BWC™ Nitrile Powder-Free Medical Examination Glove (pink) and its substantial equivalence to a predicate device.
Here's an analysis of the provided information:
1. Table of Acceptance Criteria and Reported Device Performance
The device is a medical examination glove, and its performance is evaluated against established ASTM standards and biocompatibility tests.
| Acceptance Criteria (Standards/Tests) | Predicate Device Performance | Proposed Device Performance |
|---|---|---|
| Performance Standards (Physical Properties) | ||
| ASTM D 6319-00a (Nitrile Examination Gloves) | Conforms | Conforms (ASTM D 6319-00a3 listed, likely a minor revision) |
| ASTM D 6124-01 (Powder Residue on Medical Gloves) | Conforms | Conforms (ASTM D 6124-06 listed, likely a minor revision) |
| ASTM D 5151-99 (Water penetration through finished surgical gloves) | Conforms | Conforms (ASTM D 5151-06 listed, likely a minor revision) |
| Biocompatibility | ||
| ISO Skin Irritation Study (ISO 10993-10) | Passes | Passes |
| ISO Closed Patch Sensitization Study (ISO 10993-10) | Passes | Passes |
| Cytotoxicity Study (ISO 10993-5) | Not tested (for predicate, but accepted for proposed as part of equivalence) | Passes |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document does not explicitly state the sample sizes used for each ASTM standard test or biocompatibility study. However, these standards typically specify minimum sample sizes for testing to achieve statistically significant results.
- Data Provenance: The studies were conducted by Best Glove, Inc. and are considered retrospective in the sense that the data is presented to demonstrate conformance to existing standards rather than generated from a new clinical trial. The country of origin for the data is not explicitly stated, but given the company's US address and compliance with ASTM and ISO standards, it is highly likely the testing was performed in the US or in accredited labs adhering to international standards.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This type of submission for a medical glove does not involve establishing ground truth from human expert consensus in the way an AI diagnostic device would. Instead, ground truth for material properties is established by adherence to validated ASTM and ISO test methods performed in laboratories. The "experts" involved would be qualified laboratory technicians, engineers, and scientists specialized in materials testing and biocompatibility. Their qualifications would be based on their expertise in performing and interpreting these specific tests according to regulatory and industry standards.
4. Adjudication Method for the Test Set
Not applicable in the context of this device. The conformance to standards is determined by objective laboratory measurements and interpretations of those results against the criteria defined by the respective ASTM and ISO standards. There is no ambiguous result that requires human adjudication.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. This type of study is relevant for diagnostic devices that involve human interpretation of medical images or data. For a medical examination glove, the "effectiveness" is primarily determined by its physical properties and biocompatibility, as measured by standard laboratory tests, not by human reader performance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, the performance evaluation in this submission is effectively a "standalone" evaluation of the glove's physical and biological properties. The tests (ASTM for physical properties, ISO for biocompatibility) are objective measurements of the device itself, without any human-in-the-loop diagnostic or interpretive component.
7. The Type of Ground Truth Used
The ground truth used is based on:
- Standardized Test Methods and Specifications: Conformance to specific ASTM and ISO standards (e.g., ASTM D 6319-00a for glove properties, ISO 10993 for biocompatibility). These standards define objective, measurable criteria for acceptable performance.
- Predicate Device Performance: The primary ground truth for demonstrating substantial equivalence is the performance of the legally marketed predicate device (Ultimate N-DEX® Nitrile Powder-Free Medical Examination Glove, Non-Sterile (blue), K001375). The proposed device must meet or exceed the performance of the predicate device for relevant parameters.
8. The Sample Size for the Training Set
Not applicable. This device is not an AI/ML algorithm that requires a training set. The "training" in the context of manufacturing would relate to process control and quality assurance to ensure consistent product attributes, not a data-driven training of a model.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As noted above, there is no AI/ML training set for this device.
§ 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.