(58 days)
The Vinyl Patient Examination Glove is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.
The proposed device is Powder Free Vinyl Patient Examination Gloves. The proposed device is clear, non-colored. The design of proposed device is addressing the standards as ASTM D6124, ASTM D5151, and ASTM D5250. The proposed device is non-sterile.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Vinyl Patient Examination Gloves (K182115):
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly present a "table of acceptance criteria" in the typical sense for a medical device's performance in a diagnostic or therapeutic context. Instead, it compares the proposed device's characteristics and performance against a predicate device and relevant ASTM/ISO standards. Here's a table summarizing the key performance aspects that act as de facto acceptance criteria by demonstrating equivalence to the predicate and compliance with standards:
| Acceptance Criterion (via Predicate Equivalence & Standards Compliance) | Reported Device Performance (Proposed Device) |
|---|---|
| Dimension: Length (min) | 230mm (XS), 230mm (S), 235mm (M), 245mm (L), 245mm (XL) |
| Dimension: Width (±5mm) | 80mm (XS), 85mm (S), 95mm (M), 105mm (L), 115mm (XL) |
| Dimension: Finger Thickness (min) | 0.05mm |
| Dimension: Palm Thickness (min) | 0.08mm |
| Physical Properties: Before Aging Tensile Strength (min) | 15MPa |
| Physical Properties: Before Aging Ultimate Elongation (min) | 380% |
| Physical Properties: After Aging Tensile Strength (min) | 15MPa |
| Physical Properties: After Aging Ultimate Elongation (min) | 380% |
| Physical Properties: Compliance with ASTM D5250 | Complies with ASTM D5250 |
| Freedom from Holes: ASTM D5151 AQL | AQL=1.5 (Meets ASTM D5151) |
| Powder Content: Compliance with ASTM D6124 | 0.49 mg per glove (Meets ASTM D6124 requirements) |
| Biocompatibility: Irritation (ISO 10993-10) | Not an irritant under study conditions |
| Biocompatibility: Sensitization (ISO 10993-10) | Not a sensitizer under study conditions |
| Biocompatibility: Cytotoxicity (ISO 10993-5) | Did not show potential toxicity to L-929 cells |
| Label and Labeling: FDA's Requirement | Meets FDA's Requirement |
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 (e.g., how many gloves were tested for tensile strength, or freedom from holes). It refers to compliance with standards like ASTM D5151 for Freedom from Holes, which would dictate sampling plans. The data provenance is retrospective testing of the manufactured medical device components. The company, Ping An Medical Products Co., Ltd., is located in China (Jiangxi Province), indicating the country of origin for the data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not applicable and not provided in the document. The "ground truth" for this device (patient examination gloves) is established through adherence to recognized international and national standards (ASTM, ISO) for physical properties, biocompatibility, and freedom from defects. There isn't a "ground truth" in the diagnostic sense that requires expert consensus on a clinical condition.
4. Adjudication Method for the Test Set:
This information is not applicable and not provided. Adjudication methods like "2+1" or "3+1" are typically used in clinical studies where expert consensus is needed to determine a true diagnosis or outcome. For a physical product like examination gloves, compliance with precise measurement and testing standards is the primary method of evaluation.
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:
This information is not applicable and not provided. This device is a medical glove, not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies and AI assistance are irrelevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
This information is not applicable and not provided. This device is a medical glove, not an algorithm.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for this device relies on:
- Compliance with established industry standards: ASTM D5250, ASTM D5151, ASTM D6124 for physical properties and defect levels.
- Biological safety standards: ISO 10993-10 (irritation, sensitization) and ISO 10993-5 (cytotoxicity) for biocompatibility.
- Comparison to a legally marketed predicate device (K163168) for demonstrating substantial equivalence.
8. The Sample Size for the Training Set:
This information is not applicable and not provided. This device is a physical product, not a machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable and not provided. As mentioned, there is no training set for this type of 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.