(65 days)
A medical glove intended to be worn on the hands of healthcare and similar personnel to prevent contamination between such personnel and the patient.
The Safeskin Polymer-Coated Nitrile Examination Glove are sterile disposable devices intended to be worn by healthcare and similar personnel to prevent contamination between personnel and the patient. The Safeskin Polymer-Coated Nitrile Examination Glove possesses the following technological characteristics (as compared to ASTM or equivalent standards): Dimensions Meets ASTM D 3578-99, Physical Properties Meets ASTM D 3578-99, Freedom from pinholes Meets ASTM D 5151, Powder-Free Meets ASTM D 6124 2 mg/glove maximum.
The provided text describes the 510(k) premarket notification for the "Safeskin Polymer-Coated Nitrile Examination Glove." This document focuses on demonstrating substantial equivalence to a predicate device by meeting established performance standards for examination gloves.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|
| ASTM D 3578-99 Dimensions | Meets ASTM D 3578-99 Dimensions |
| ASTM D 3578-99 Physical Properties | Meets ASTM D 3578-99 Physical Properties (with the exception of elongation) |
| ASTM D 3578-99 Freedom from pinholes | Meets ASTM D 3578-99 Freedom from pinholes |
| ASTM D 5151 (Freedom from pinholes) | Meets ASTM D 5151 |
| ASTM D 6124 Powder-Free | Meets ASTM D 6124 (2 mg/glove maximum) |
| Biocompatibility (Primary Skin Irritation in Rabbits) | Passes |
| Biocompatibility (Guinea Pig Sensitization) | Passes |
Note: The text explicitly states that the device meets ASTM D 3578-99 with the exception of elongation. It then reiterates that it meets "ASTM D 3578-99 Physical Properties" but implies this exception still applies, as it was mentioned earlier in the same paragraph.
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size used for the tests to meet the ASTM standards or biocompatibility tests. It also does not mention the country of origin of the data or whether it was retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth and Qualifications of Those Experts
This information is not applicable to this type of device submission. The "ground truth" for examination gloves is defined by adherence to established industry performance standards (ASTM standards) and biocompatibility tests, not by expert consensus on interpretations.
4. Adjudication Method for the Test Set
This information is not applicable. Adjudication methods are typically used in studies involving human interpretation (e.g., medical imaging) to resolve discrepancies in expert opinions. Here, the assessment is against objective physical and chemical standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not performed. This type of study is relevant for AI-powered diagnostic devices where the AI assists human readers. This device is a medical glove.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
No, a standalone performance assessment is not applicable. This device is a simple physical barrier, not an algorithm.
7. The Type of Ground Truth Used
The ground truth used is based on established industry performance standards (ASTM standards) and biocompatibility testing results. These standards define the acceptable physical properties, freedom from defects, and biological safety of the examination glove.
8. The Sample Size for the Training Set
This information is not applicable as this device does not involve a training set. Machine learning algorithms, which require training sets, are not used in the development or evaluation of this simple medical device.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no training set for this device.
Summary of the Study:
The study proving the device meets acceptance criteria is a series of standardized laboratory tests. These tests evaluate the physical properties, integrity (freedom from pinholes), powder content, and biocompatibility of the "Safeskin Polymer-Coated Nitrile Examination Glove" against the specified ASTM (American Society for Testing and Materials) standards. The document states that the glove "will meet the current specifications" for ASTM D 3578-99 (with the exception of elongation), ASTM D 5151, and ASTM D 6124, and "Passes" biocompatibility tests. The specific details of these tests (e.g., number of gloves tested for pinholes, the exact methodology for physical property measurement) are not provided in this summary but would be part of the full submission. The document concludes that these performance test data support a determination of substantial equivalence to a predicate 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.