(107 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 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, Power-Free Vinyl Patient Examination Glove, 80 LYZ, and meets all requirements of ASTM standard D-5250-00E4
The provided text describes the acceptance criteria and the study conducted for the "Shijiazhuang Hongxiang Plastic Products Co., Ltd. Vinyl Co-Polymer Powder Free Examination Gloves, Blue Color." This is a Class I medical device (patient examination glove). The evaluation focuses on demonstrating substantial equivalence to a predicate device, as per FDA 510(k) requirements.
Here's an analysis of the provided information in the requested format:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Standard / Test) | Reported Device Performance |
|---|---|
| Physical and Dimensions Testing | Met requirements based on ASTM D-5250-00E4 (Inspection level S-2, AQL 4.0) |
| Integrity (Pinhole Test) | Met FDA 1000 ml. Water Fill Test requirements based on ASTM D-5151-99 (AQL 2.5, inspiration level G-1) |
| Biocompatibility (Irritation) | No primary skin irritant reactions in Primary Skin Irritation testing |
| Biocompatibility (Sensitization) | No sensitization reactions in Skin Sensitization testing |
| Residual Powder | Met "powder-free" claims (contains no more than 2 mg powder per glove) based on ASTM D-6124-06 |
2. Sample Size Used for the Test Set and Data Provenance:
- Physical and Dimensions Testing: Inspection level S-2, AQL 4.0. The specific number of gloves tested is not provided, but AQL (Acceptable Quality Limit) indicates the maximum acceptable percentage of defective items.
- Pinhole Test (Water Fill Test): AQL 2.5, inspection level G-1. The specific number of gloves tested is not provided, but AQL indicates the maximum acceptable percentage of defective items.
- Primary Skin Irritation and Skin Sensitization Testing: The sample size for these biological tests is not specified in the document.
- Residual Powder Test: The sample size is not specified in the document.
- Data Provenance: The origin of the data is from testing performed by Shijiazhuang Hongxiang Plastic Products Co., Ltd. in China. The study appears to be prospective as it involves new testing of the device for submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Not applicable. This device is a Class I examination glove, and the evaluation does not involve diagnostic interpretation that would require expert human readers to establish ground truth from medical images or clinical observations. The ground truth is objective measurements against established ASTM standards and FDA requirements.
4. Adjudication Method for the Test Set:
- Not applicable. As the tests are objective measurements against defined physical, chemical, and biological standards (e.g., AQL, mg of powder, presence/absence of irritation), there is no adjudication process involving multiple human reviewers.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No. An MRMC study is not relevant for this type of device. Such studies are typically conducted for diagnostic imaging devices or algorithms where human interpretation is a key component.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, in essence. The testing performed (physical, dimensional, pinhole, biocompatibility, residual powder) is equivalent to a "standalone" evaluation of the device's inherent properties without human interaction or interpretation as part of its primary function. The device itself is not an algorithm, but its performance is measured directly.
7. The Type of Ground Truth Used:
- Objective Standards and Measurement: The ground truth is established by:
- ASTM Standards: D-5250-00E4 (physical and dimensions), D-5151-99 (pinhole/water fill), D-6124-06 (residual powder).
- FDA Requirements: Specific pinhole requirements and biocompatibility expectations.
- Defined Limits: E.g., no more than 2 mg powder per glove for "powder-free" claim.
- Direct Biological Observation: For skin irritation and sensitization tests.
8. The Sample Size for the Training Set:
- Not applicable. This device is not an AI/ML algorithm or a diagnostic tool that requires a "training set." The testing is for a physical medical product.
9. How the Ground Truth for the Training Set was Established:
- Not applicable. 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.