(28 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 Nitrile Patient Examination Glove, 80LZA, and meets all requirements of ASTM Standard D6319-00a1.
The provided text describes the 510(k) summary for Shijiazhuang Great Vision Plastics Products Co., Ltd. Powdered (Blue) Nitrile Patient Examination Gloves. This product is a Class I medical device and, as such, the acceptance criteria and study information provided mainly pertain to meeting established industry standards for physical properties and biocompatibility, rather than advanced AI/software performance metrics.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Physical and Dimensions Testing (ASTM-D-6319-00a1) | All testing meets requirements for Physical and Dimensions Testing, Inspection Level S-2, AQL 4.0. |
| Pinhole Detection (FDA 1000 ml. Water Fill Test) | Meets requirements with samplings of AQL 2.5, Inspection Level G-1. |
| Primary Skin Irritation | No primary skin irritant reactions. |
| Skin Sensitization (Allergic Contact Dermatitis) | No sensitization reactions. |
| Residual Powder (ASTM D6124-01 for Starch) | Meets "powder-free" claims (contains no more than 120 mg powder per glove). |
Note: The document explicitly states "There are no special labeling claims and we do not claim our gloves as hypoallergenic on our labels."
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "samplings" for the FDA 1000 ml. Water Fill Test (AQL 2.5, Inspection Level G-1) and "inspection" for Physical and Dimensions Testing (Inspection Level S-2, AQL 4.0). For Residual Powder testing, it refers to "finished inspection."
- Specific sample sizes in units (e.g., number of gloves) are not explicitly provided. The AQL (Acceptable Quality Limit) levels refer to a statistically determined sampling plan, not a fixed number.
- Data Provenance: The tests were performed on the manufacturer's gloves, Shijiazhuang Great Vision Plastics Products Co., Ltd., based in Hebei Province, P.R. China. The testing was conducted as part of the manufacturing and submission process, implying it is prospective with respect to the regulatory submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Not applicable for this type of device. The "ground truth" for glove performance is established by meeting objective, standardized physical and chemical test specifications (e.g., ASTM standards, FDA water fill test). There is no "expert consensus" on an image or clinical finding for this device.
- Biocompatibility tests (Primary Skin Irritation and Skin Sensitization) are typically evaluated by qualified toxicologists or dermatologists, but the number and specific qualifications are not detailed in this summary.
4. Adjudication Method for the Test Set
- Not applicable. The tests involve objective measurements and pass/fail criteria based on quantitative standards, not subjective interpretations requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, this is not applicable. This device is a patient examination glove, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study comparing human reader performance with and without AI assistance is irrelevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not applicable. This device is a physical product (glove), not a software algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this device consists of:
- Industry Standards: ASTM Standard D6319-00a1 (for physical and dimensional properties).
- Regulatory Test Methods: FDA 1000 ml. Water Fill Test (for pinhole detection).
- Biocompatibility Standards: Implicitly, standards for evaluating skin irritation and sensitization.
- Specific Test Methods for Material Properties: ASTM D6124-01 (for residual starch powder).
8. The Sample Size for the Training Set
- Not applicable. This product is a physical medical device, not a machine learning model. Therefore, there is no "training set."
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As there is no training set, this question is not relevant.
§ 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.