(173 days)
Powder free vinyl 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.
powder free vinyl patient examination gloves, Clear(non-colored) that meets all of the requirements of ASTM standard D 5250-06.
The provided text describes a 510(k) summary for "Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)". This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study proving performance against acceptance criteria in the typical sense of AI/software device evaluation.
Therefore, many of the requested points related to AI/software device studies (like sample size for test sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, training sets, etc.) are not applicable to this type of medical device submission. The device is a physical product (gloves), not a software or AI tool.
However, I can extract the relevant acceptance criteria and reported performance based on the information provided, which refers to conformance with ASTM standards.
Here's the breakdown of the information as it applies to this specific submission:
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Test | Acceptance Criteria (from ASTM standards and FDA) | Reported Device Performance (by manufacturer) | Result of Comparison |
|---|---|---|---|
| Device Description & Specifications | Meet all current specifications listed under ASTM Specification D5250 (If vinyl) | Meets ASTM D5250 | Substantially equivalent |
| Material | If the glove is made of a polymer or other type of material, identify the material. | PVC | Substantially equivalent |
| Dusting or Donning Powder / Lubricant | If a donning lubricant is used, state the composition and include biocompatibility data for the lubricant; also state name, manufacturer, and address. (For "powder-free" gloves, meet residual powder limits per ASTM D6124). | PU (Polyurethane) as surface coating agent. (The document implies it is powder-free, aligned with the device name and ASTM D6124 conformance) | Substantially equivalent |
| Product Specifications | Certify that finished "powder-free" gloves meet ASTM D5250. | Meets ASTM D5250 | Substantially equivalent |
| Performance Data (Holes Detection) | Meet ASTM D5151 (Detection of Holes in Medical Gloves) | Meets ASTM D5151 | Substantially equivalent |
| Performance Data (Residual Powder) | Meet ASTM D6124 (Residual Powder on Medical Gloves) | Meets ASTM D6124 | Substantially equivalent |
| Biocompatibility | Skin Irritation: Dermal and Sensitization studies per ISO 10993-10 | SKIN IRRITATION DERMAL and SENSITIZATION STUDIES Meets ISO 10993-10 | Substantially equivalent |
| Water Leak Test on Pinhole AQL | Meet FDA requirements for AQL (Implicitly covered by ASTM D5151 for holes detection) | The conclusion states: "Powder Free Vinyl Patient Examination Gloves meet the ASTM standard or equivalent standard and FDA requirements for waterleak test on pinhole AQL..." (specific AQL not stated in table, but overall claim made) | - |
| Labeling | Requirements for labeling (e.g., "Powder-Free", "Patient Examination Glove", "Single Use Only", "Manufactured For:", "Lot") | Labeling includes: -Powder-Free -Patient Examination Glove -Single Use Only - Manufactured For: - Lot | Substantially equivalent |
Study Proving Device Meets Acceptance Criteria:
The study proving the device meets the acceptance criteria is not described as a single, centralized study in the document. Instead, it refers to the device's conformance with recognized consensus standards (ASTM D5250-06, ASTM D6124-06, ASTM D5151, and ISO 10993-10) and FDA requirements (specifically 21 CFR 800.20 for water leak test on pinhole AQL).
The manufacturer asserts that their "Powder free vinyl patient examination gloves, Clear(non-colored) meet requirements per ASTM D5250-06, per ASTM D6124-06, per 21 CFR 800.20 and ISO10993-10." This implies that the device successfully passed testing according to the methodologies outlined in these standards.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not explicitly stated in the summary. For physical products tested against ASTM standards, the sample sizes are typically defined within the specific standard's test methods (e.g., for AQL testing for holes, specific sample plans are used).
- Data Provenance: Not explicitly stated beyond "nonclinical submitted". Given the submitter's address in China, it's presumed the testing was conducted in China. It is a retrospective evaluation against established standards.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not Applicable. This is a physical device submission. Ground truth in the context of expert consensus for AI models is not relevant here. Conformance is determined by physical and chemical testing against objective standards.
4. Adjudication Method for the Test Set:
- Not Applicable. As per point 3, this is a physical device tested against standards; an adjudication method in the context of expert review is not relevant.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
- No, Not Applicable. MRMC studies are for evaluating diagnostic performance of imaging systems or AI software. This is a physical glove.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- No, Not Applicable. This is a physical device.
7. The Type of Ground Truth Used:
- For this device, "ground truth" equates to the objective measurements and results obtained from testing the gloves against the criteria and methodologies defined in the referenced ASTM standards (D5250, D5151, D6124) and ISO standard (10993-10), as well as FDA regulations for AQL. These are direct physical properties and performance characteristics.
8. The Sample Size for the Training Set:
- Not Applicable. This is a physical device; there is no "training set" in the context of an AI/software algorithm.
9. How the Ground Truth for the Training Set Was Established:
- Not Applicable. As per point 8.
§ 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.