(96 days)
A glove 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 a disposable device intended for medical purposes 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, 80LYZ, powdered with Absorbable Dusting Powder, USP, Class III and meets all requirements of ASTM Standard D5250-92.
This submission describes the clearance of "Synthetic Powdered (Yellow) Vinyl Patient Examination Gloves-Powdered" manufactured by SHIJIAZHUANG GREAT EAGLE PLASTICS PRODUCTS CO., LTD. This is a Class I medical device (21 CFR 880.6250) and is intended for medical purposes to prevent contamination between patients and examiners. The device's performance was evaluated against ASTM Standard D5250-92 and FDA's 1000 ml water fill test.
Here’s a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (from ASTM Standard D5250-92 & FDA 1000 ml Water Fill Test) | Reported Device Performance |
|---|---|
| Physical and Dimensions Testing: All requirements of ASTM D5250-92 (Specific parameters not detailed in the provided text, but generally include dimensions, tensile strength, elongation, etc.) | All testing meets requirements for Physical and Dimensions Testing conductive on gloves, Inspection Level S-4, AQL 4.0. |
| Pinhole / Water Leakage Test: Requirements of FDA 1000 ml Water Fill Test (Specific AQL level for leakage) | FDA 1000 ml Water Fill Test conducted with samplings of AQL 2.5, Inspection Level S-4, meeting these requirements. |
| Primary Skin Irritation: No primary skin irritant reactions | No primary skin irritant reactions observed. |
| Skin Sensitization (Allergic Contact Dermatitis): No sensitization reactions | No sensitization reactions observed. |
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size:
- For Physical and Dimensions Testing: AQL 4.0, Inspection Level S-4 (Specific number of gloves not provided, but AQL and inspection level define the sampling plan).
- For FDA 1000 ml Water Fill Test: AQL 2.5, Inspection Level S-4 (Specific number of gloves not provided, but AQL and inspection level define the sampling plan).
- For Primary Skin Irritation and Skin Sensitization: Not specified, but generally follows standard biological evaluation protocols.
- Data Provenance: Not explicitly stated, but assumed to be generated by the manufacturer or a contract research organization in China, as the manufacturer is based in Shijiazhuang, Hebei Province, P.R. China. The studies are prospective, conducted specifically for this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
- Not applicable. For this type of device (patient examination gloves), "ground truth" is established through standardized physical, chemical, and biological performance tests rather than expert interpretation of medical images or clinical data. The tests are objective measurements against established criteria.
4. Adjudication Method for the Test Set:
- Not applicable. As the "ground truth" is based on objective measurements from standardized tests, there is no need for expert adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size:
- No. An MRMC study is not relevant for this device. It is generally used for evaluating diagnostic devices where human readers interpret medical data.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) study was done:
- Not applicable. This device is a physical product (gloves), not an algorithm or AI system. Its performance is evaluated through physical and biological testing.
7. The Type of Ground Truth Used:
- The "ground truth" for the performance evaluation of the gloves is based on:
- Standardized Test Methods: Adherence to ASTM D5250-92 for physical properties and dimensions.
- Regulatory Test Methods: Compliance with the FDA 1000 ml Water Fill Test for barrier integrity (pinhole detection).
- Biocompatibility Testing: Results from Primary Skin Irritation and Skin Sensitization tests.
8. The Sample Size for the Training Set:
- Not applicable. This device is not an AI/ML algorithm; 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 for an AI/ML algorithm.
§ 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.