(91 days)
The Powder Free Vinyl Patient Examination Gloves (Green) is disposable non-sterile device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Powder Free Vinyl Patient Examination Gloves (Green) are Patient Examination Gloves, Disposable, single use only and non-sterile. The gloves are made of vinyl materials and are powder free. The physical and performance characteristics of the devices meet all requirements of ASTM D5250-06 (Reapproved 2011)--Standard Specification For Poly (Vinyl Chloride) Gloves For Medical Application.
The provided text describes the submission for a 510(k) premarket notification for "Powder Free Vinyl Patient Examination Gloves (Green)". This document type does not include information about AI/ML device performance or large-scale comparative effectiveness studies involving human readers, as it pertains to a Class I medical device (patient examination gloves). The "acceptance criteria" and "study" described herein are related to the physical and chemical properties of the gloves, demonstrating their substantial equivalence to a predicate device.
Therefore, many of the requested fields regarding AI/ML device performance, human reader studies, and AI-specific ground truth establishment cannot be answered from the provided text.
Here's a breakdown of the available information regarding the glove's acceptance criteria and the study proving it meets these criteria:
Device Name: Powder Free Vinyl Patient Examination Gloves (Green)
Device Type: Patient Examination Glove (Class I Medical Device)
Regulation Number: 21 CFR 880.6250
1. Table of Acceptance Criteria and Reported Device Performance:
The document presents a comparison between the subject device and a predicate device (Tangshan Hongyun Plastic Products Company Limited Powder-Free Yellow Vinyl Patient Examination Gloves, K141878) against various standards.
| Characteristic | Standard | Acceptance Criteria (Predicate Device) | Reported Device Performance (Subject Device) | Result of Comparison |
|---|---|---|---|---|
| General | ||||
| Product Code | LYZ | LYZ | Same | |
| Intended Use | Non-sterile disposable for medical purposes, worn on hand/finger to prevent contamination. | Non-sterile disposable for medical purposes, worn on hand/finger to prevent contamination. | Same | |
| Size | S/M/L/XL | S/M/L/XL | Same | |
| Materials Used | PVC | PVC | Same | |
| Dusting or Donning Powder | PU | PU | Same | |
| Single Patient Use | / | Single patient use | Single patient use | Similar |
| Physical Properties | ||||
| Dimensions: Length | ASTM D 5250-06 (2011) | Meets 230 mm min for all sizes | Meets 230 mm min for all sizes | Similar |
| Dimensions: Width | ASTM D 5250-06 (2011) | S: 83-86 mm, M: 94-97 mm, L: 104-107 mm, XL: 113-115 mm | S: 85±5 mm, M: 95±5 mm, L: 105±5 mm, XL: 115±5 mm | Similar |
| Dimensions: Thickness | ASTM D 5250-06 (2011) | Palm: 0.08 mm min, Finger: 0.05 mm min | Palm: 0.08 mm min, Finger: 0.05 mm min | Similar |
| Tensile Strength (before/after aging) | ASTM D 5250-06 (2011) | ≥11 MPa | ≥11 MPa | Similar |
| Elongation (before/after aging) | ASTM D 5250-06 (2011) | ≥300% | ≥300% | Similar |
| Freedom from Pinholes | ASTM D 5250-06 (2011), ASTM D5151-06 (Reapproved 2011) | G-I, AQL 2.5 | G-I, AQL 2.5 | Similar |
| Residual Powder | ASTM D 5250-06 (2011), ASTM D6124-06 (Reaffirmation 2011) | Below 2mg of residual powder | Not more than 2mg per glove | Similar |
| Biocompatibility | ||||
| Skin Irritation | ISO 10993-10 | Not an irritant | Not an irritant | Same |
| Sensitization | ISO 10993-10 | Not a sensitizer | Not a sensitizer | Same |
| Performance Data | ||||
| ASTM Standards Met | ASTM D5151-06(2011), ASTM D 5250-06 (2011), ASTM D6124-06(2011) | ASTM D5151-06(2011), ASTM D 5250-06 (2011), ASTM D6124-06(2011) | Same |
The acceptance criteria are generally "Meets" the specified ASTM standards and biocompatibility results (e.g., "not an irritant"). The reported device performance indicates that the subject device also meets these criteria, supporting substantial equivalence.
2. Sample Size Used for the Test Set and the Data Provenance:
The document states that the physical and performance characteristics meet "all requirements of ASTM D5250-06 (Reapproved 2011)". This implies that standard testing methodologies as defined by these ASTM standards were followed. However, the specific sample sizes used for each test (e.g., how many gloves were tested for pinholes, tensile strength, etc.) are not explicitly provided in this summary.
- Data Provenance: The testing was conducted by Supermax Plastic Products Co., Ltd. in China (Hebei Province). The data is non-clinical testing performed to support substantial equivalence. It is inherently retrospective in the context of the 510(k) submission, as these tests would have been completed prior to submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
Not applicable. This is a physical product testing scenario, not a study requiring expert clinical labeling or ground truth establishment in the context of AI/ML. The "ground truth" here is determined by objective measurements against established ASTM and ISO standards by qualified testing personnel.
4. Adjudication Method for the Test Set:
Not applicable. This is not a study requiring adjudication of expert opinions. Device performance is measured against objective, standardized criteria.
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:
Not applicable. This document pertains to patient examination gloves, not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This document pertains to patient examination gloves, not an algorithm.
7. The Type of Ground Truth Used:
The "ground truth" for this device is based on objective, standardized measurements against the specifications outlined in relevant industry standards, specifically:
- ASTM D 5250-06 (2011) - Standard Specification For Poly (Vinyl Chloride) Gloves For Medical Application
- ASTM D5151-06 (2011) - Standard Test Method For Detection Of Holes In Medical Gloves
- ASTM D6124-06 (2011) - Standard Test Method For Residual Powder On Medical Gloves
- ISO 10993-10 (third edition 2010-08-01) - Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
- 21 CFR 800.20 - General requirements for device labeling
8. The Sample Size for the Training Set:
Not applicable. This is not an AI/ML device, so there is no training set in that context. The "training" for manufacturing would be industrial process control, not data training.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no AI/ML training set. The manufacturing processes would be subject to quality control and good manufacturing practices (GMP) to ensure the product meets specifications.
§ 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.