(153 days)
A patient examination glove is a disposable device intended for medical purposes that is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste or environment.
A patient examination glove is disposable device intended for medical a purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Classified by FDA's General and Plastic Surgery Device panel as Class I. 21 CFR 880.6250, Powder-Free Vinyl Patient Examination Glove, 80LYZ, and meets all requirements of ASTM Standard D5250-00.
Here's a breakdown of the acceptance criteria and study information based on the provided document:
This document describes the 510(k) submission for Shijiazhuang Great Vision Plastics Products Co., Ltd. Synthetic (White) Vinyl Patient Examination Gloves-Powder Free. As such, the "device" in this context refers to these examination gloves. The studies described are primarily non-clinical, focusing on manufacturing standards and material properties rather than clinical performance (e.g., diagnostic accuracy of an AI algorithm).
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|
| Physical and Dimensions Testing (ASTM-D-5250-00) | Meets requirements |
| Inspection Level S-2 | Achieved |
| AQL 4.0 | Achieved |
| Pinhole Water Fill Test (FDA 1000 ml.) | Meets requirements |
| AQL 2.5 | Achieved |
| Inspection Level I | Achieved |
| Primary Skin Irritation | No primary skin irritant reactions |
| Skin Sensitization (Allergic Contact Dermatitis) | No sensitization reactions |
| Residual Powder Test (ASTM D6124-01) | Meets "powder-free" claims (contains no more than 2 mg powder per glove) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample sizes for each test performed (e.g., how many gloves were tested for pinholes, or how many subjects for skin irritation). It refers to:
- Physical and Dimensions Testing: "Inspection Level S-2, AQL 4.0" (These are sampling plans from quality control standards, implying a specific number of gloves would be inspected from a lot, but the exact number isn't given).
- FDA 1000 ml. Water Fill Test: "AQL 2.5, Inspection Level I" (Similarly, a sampling plan).
- Primary Skin Irritation and Skin Sensitization: The number of subjects is not specified.
- Residual Powder Test: Not specified.
Data Provenance: Not explicitly stated, but the tests were conducted by or for the manufacturer, Shijiazhuang Great Vision Plastics Products Co., Ltd., based in Hebei Province, P.R. China.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not applicable. This device is a physical product (gloves), not an AI/diagnostic device that relies on expert interpretation for ground truth establishment. The "ground truth" here is defined by physical and chemical properties and patient safety endpoints, measured by established testing methods.
4. Adjudication Method for the Test Set
Not applicable. Since the tests are objective measurements against predefined standards (e.g., water leak, powder content, skin reaction), there is no need for expert adjudication in the way it would be applied to subjective image interpretation or clinical diagnosis.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not done. This is not an AI-assisted diagnostic device, so an MRMC study comparing human readers with and without AI assistance is not relevant.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not applicable. This is not an algorithm or AI device.
7. Type of Ground Truth Used
The "ground truth" for the performance claims of these gloves is based on:
- Standardized Physical Measurements: Adherence to ASTM-D-5250-00 for physical properties and dimensions, and ASTM D6124-01 for residual powder.
- Biocompatibility Testing: Results from primary skin irritation and sensitization tests.
- FDA Pinhole Requirements: Passing the FDA's 1000 ml Water Fill Test.
8. Sample Size for the Training Set
Not applicable. This is not a machine learning or AI device that requires a training set. The "training" for glove manufacturing would involve process control and quality assurance, not data training in a computational sense.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set in the context of an AI device, no ground truth needs to be established for it.
§ 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.