(26 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, Powdered Vinyl Patient Examination Glove, 80L YZ, and meets all requirements of ASTM Standard D5250-00E4.
This submission is for a Class I medical device, "Grand Work Plastics Products Co., Ltd. Synthetic Vinyl Patient Examination Gloves—Powdered," which is a disposable patient examination glove. As such, the acceptance criteria and supporting studies are focused on performance characteristics relevant to patient examination gloves, rather than those for complex diagnostic algorithms.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard / Test) | Reported Device Performance |
|---|---|
| ASTM D5250-00E4 (General) | Meets all requirements |
| ASTM D5250-00E4 (Physical and Dimensions Testing) | Meets requirements (Inspection Level S-2, AQL 4.0) |
| ASTM D5151-99 (FDA 1000 ml. Water Fill Test for pinholes) | Meets requirements (AQL 2.5, Inspection Level I) |
| Primary Skin Irritation | No primary skin irritant reactions |
| Skin Sensitization (allergic contact dermatitis) | No sensitization reactions |
| ASTM D6124-01 (Residual Powder Test for Starch) | Meets (contains no more than 10 mg/dm²) in accordance with "powdered" claims |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample sizes used for each test. Instead, it refers to "Inspection Level S-2, AQL 4.0" for physical and dimensions testing, and "AQL 2.5, Inspection Level I" for the water fill test. These are sampling plans from the referenced ASTM standards, which define how many units are tested from a lot to determine acceptance.
The data provenance is not specified in terms of country of origin, but the testing was performed by the manufacturer, Grand Work Plastics Products Co., Ltd., which is located in Zanhuang, Hebei Province, P.R. China. The studies are non-clinical (laboratory/bench testing), not involving human subjects.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This question is not applicable in the context of this device. The "ground truth" for patient examination gloves is established by the specified ASTM standards and FDA guidelines, which define measurable physical and chemical properties and their acceptable limits. Expert consensus as typically understood for diagnostic algorithms (e.g., radiologists interpreting images) is not used here.
4. Adjudication Method for the Test Set
Adjudication methods (like 2+1, 3+1) are typically used for subjective diagnostic interpretations in the context of clinical studies involving multiple human readers. This is not relevant for the objective, standardized non-clinical tests performed on patient examination gloves. The tests involve direct measurement and adherence to predefined criteria.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study involves comparing the diagnostic performance of multiple human readers, often with and without AI assistance, on a set of cases. This is completely irrelevant for a patient examination glove.
6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done
While the term "standalone study" usually refers to the performance of an AI algorithm without human intervention, if we interpret it generally as the device's inherent performance without human human-in-the-loop interaction, then yes, the tests described (physical, dimensions, water fill, skin irritation, sensitization, residual powder) assess the standalone performance of the glove itself against established standards. There is no "algorithm" involved.
7. The Type of Ground Truth Used
The ground truth used for this device is based on established industry standards and regulatory requirements. Specifically:
- ASTM Standard D5250-00E4: Standard Specification for Poly(vinyl chloride) Patient Examination Gloves.
- ASTM Standard D5151-99: Standard Test Method for Detection of Pinholes in Medical Gloves.
- ASTM D6124-01: Standard Test Method for Residual Powder on Medical Gloves.
- Biocompatibility standards: For primary skin irritation and sensitization.
These standards define the acceptable range or absence of certain characteristics (e.g., tensile strength, elongation, freedom from holes, absence of irritation).
8. The Sample Size for the Training Set
This question is not applicable. "Training set" refers to data used to train a machine learning algorithm. This device is a physical product, not an AI algorithm, and therefore does not have a training set.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable, as there is no training set for a physical patient examination glove.
§ 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.