(62 days)
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
Powdered Latex Patient Examination Glove with Protein Content Labeling Claim (Contains 200 Micrograms per dm2 of glove or Less of Water Extractable Protein) meets all the current specification for ASTM D3578-05 (2010).
Acceptance Criteria and Device Performance Study for K120693 - Powdered Latex Patient Examination Glove
This document describes the acceptance criteria and the study demonstrating that the "Powdered Latex Patient Examination Glove with Protein Content Labeling Claim (Contains 200 Micrograms per dm² of glove or Less of Water Extractable Protein)" (K120693) meets these criteria.
1. Table of Acceptance Criteria and Reported Device Performance
The device's performance was evaluated against established ASTM standards and ISO standards for biocompatibility.
| Characteristic | Acceptance Criteria (Standards) | Reported Device Performance |
|---|---|---|
| Dimensions | ASTM D 3578-05 (2010) | Meets |
| Physical Properties | ASTM D 3578-05 (2010) | Meets |
| Freedom from pin-holes | ASTM D 5151-99 (2006) & ASTM D 3578-05 (2010) | Meets |
| Powder Amount | ASTM D 6124-06 & ASTM D 3578-05 (2010) | Meets |
| Protein Content | ASTM D 5712-10 & ASTM D 3578-05 (2010) | Meets |
| Biocompatibility: | ||
| - Dermal Sensitization | ISO 10993-10:2010 | Not a contact skin sensitizer |
| - Primary Skin Irritation Test | ISO 10993-10:2010 | Not a primary skin irritant |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes used for each specific test or the country of origin for the data. However, the evaluation relies on compliance with established ASTM and ISO standards, which typically involve specific sampling plans and test methods. The studies are non-clinical performance tests.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable. For this type of medical device (patient examination gloves), the "ground truth" is established by adherence to recognized national and international consensus standards (ASTM and ISO), not by expert consensus on clinical data or image interpretation. The tests are laboratory-based and objective measurements.
4. Adjudication Method for the Test Set
Not applicable. The performance testing involves objective measurements against established standard specifications, not subjective interpretation requiring adjudication among experts.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This device is a patient examination glove, and its performance is assessed through non-clinical laboratory testing against physical, chemical, and biocompatibility standards. MRMC studies are typically relevant for diagnostic imaging or similar devices that involve human interpretation of results.
6. Standalone Performance Study
Yes, a standalone (algorithm only without human-in-the-loop performance) study was done in the sense that the device itself, a physical product, was subjected to a series of laboratory tests to evaluate its inherent characteristics against the specified standards. Human interaction is limited to conducting the tests according to the standard protocols and recording the objective results.
7. Type of Ground Truth Used
The ground truth used is based on established national and international consensus standards (ASTM and ISO). These standards define objective pass/fail criteria and test methodologies for dimensions, physical properties, freedom from pinholes, powder amount, protein content, and biocompatibility.
8. Sample Size for the Training Set
Not applicable. This device is a physical product, not an algorithm or AI model that requires a training set. The evaluation is based on direct testing of the manufactured product batches against standardized criteria.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" for this device. The ground truth for evaluating the device's performance is established by the specified ASTM and ISO standards themselves, which outline the acceptable ranges and test methods.
§ 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.