(125 days)
A 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.
The device is powdered synthetic vinyl exam glove. They are nonsterile, single use, disposable gloves.
Here's an analysis of the provided documents regarding the acceptance criteria and study for the Synthetic Vinyl Examination Glove, Powdered:
Acceptance Criteria and Device Performance
The documents primarily focus on demonstrating substantial equivalence to a predicate device for regulatory clearance. The "acceptance criteria" are implied by the performance standards and tests the device claims to have met or exceeded.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied Standard/Test) | Reported Device Performance |
|---|---|
| Physical Performance: | |
| ASTM D5250 (Standard Specification for Poly(vinyl chloride) Gloves for Medical Application) | Met and/or exceeded requirements |
| FDA Water Leak Test (before & after aging) | Met and/or exceeded requirements |
| Biocompatibility/Safety: | |
| Primary Skin Irritation Study | Met and/or exceeded requirements |
| Dermal Sensitization Study | Met and/or exceeded requirements |
| FDA Surgical Glove Bio-Burden Test | Met and/or exceeded requirements |
2. Sample Size Used for the Test Set and Data Provenance
The documents do not explicitly state the sample sizes used for each of the tests (e.g., number of gloves for water leak, number of subjects for skin irritation).
The data provenance is stated as: "All tests were performed in a certified testing laboratory." No country of origin for the data is specified, but the submission is to the U.S. FDA. The studies are prospective in the sense that they were conducted for the purpose of this 510(k) submission, rather than being retrospective analyses of existing data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is generally not applicable to the performance testing of a medical device like an examination glove. The "ground truth" for these tests are the established and recognized standard testing methodologies specified by ASTM or FDA. There isn't an "expert" concensus on whether a glove leaks, but rather a pass/fail determination based on a defined protocol.
4. Adjudication Method for the Test Set
Not applicable. As described above, these are objective physical and biological tests, not subjective interpretations requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No. An MRMC study is typically for evaluating diagnostic or imaging devices where human readers interpret results. This is a simple medical device (examination glove) with clear performance metrics.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This question is not relevant to this device. This device is not an algorithm or AI. Its performance is inherent in its physical and material properties.
7. The Type of Ground Truth Used
The "ground truth" for the performance tests (water leak, irritation, sensitization, bioburden, ASTM D5250 compliance) is based on:
- Established Standard Specifications: ASTM D5250 dictates material properties and performance requirements for the glove.
- Defined Test Protocols: FDA Water Leak, Primary Skin Irritation, Dermal Sensitization, and Surgical Glove Bio-Burden tests have specific, standardized methodologies to determine compliance.
8. The Sample Size for the Training Set
Not applicable. This is not a machine learning or AI device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no 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.