(104 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 Gloves, 80 LYZ, and meets all requirements of ASTM standard D-5250-00E4.
The document describes the acceptance criteria and the study conducted for the Shijiazhuang Junfei Plastic Products Co., Ltd. Powder Free (White) Vinyl Patient Examination Gloves.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Test/Standard | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Physical Performance | ASTM-D-5250-00E4 (General Physical & Dimensions) | Meets all requirements | Meets all requirements |
| Barrier Integrity | FDA 1000 ml. Water Fill Test | AQL 2.5, Inspection Level I requirements | Meets requirements |
| Biocompatibility | Primary Skin Irritation | No primary skin irritant reactions | No primary skin irritant reactions |
| Biocompatibility | Skin Sensitization (Allergic Contact Dermatitis) | No sensitization reactions | No sensitization reactions |
| Powder Content | Residual Powder Test (ASTM D6124-06) | No more than 2 mg powder per glove | Meets "powder-free" claims (contains ≤ 2 mg powder/glove) |
2. Sample Size Used for the Test Set and Data Provenance:
- Physical Performance (ASTM-D-5250-00E4): "Inspection level S-2, AOL 4.0" is mentioned, which refers to a sampling plan for attributes. The exact numerical sample size is not explicitly stated in the provided text, but it indicates a statistical sampling approach.
- Barrier Integrity (FDA 1000 ml. Water Fill Test): "samplings of AQL 2.5, inspection level I" is mentioned, again referring to a statistical sampling plan. The exact numerical sample size is not explicitly stated.
- Biocompatibility (Skin Irritation and Sensitization): The specific sample sizes for these tests are not provided in the document.
- Residual Powder Test (ASTM D6124-06): The specific sample size for this test is not provided.
- Data Provenance: The tests were conducted internally by Shijiazhuang Junfei Plastic Products Co., Ltd. (or on their behalf) as part of their production and quality control processes. The origin of the data is China, and it appears to be a prospective set of tests conducted on manufactured glove batches.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not applicable and not provided in the document. The tests performed are objective, laboratory-based, and standard-driven (e.g., ASTM standards, FDA water fill test), which do not typically require expert consensus for establishing ground truth in the same way clinical imaging or diagnostic studies might.
4. Adjudication Method for the Test Set:
This information is not applicable and not provided. The assessment of polyvinyl examination glove performance is based on defined physical and chemical test methods against established pass/fail criteria, not on subjective expert review or adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
This information is not applicable. The device is a physical medical device (examination gloves), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to AI assistance for human readers is irrelevant to this submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This information is not applicable. The device is a physical medical device, not an algorithm, so a standalone algorithm performance study is not relevant.
7. The Type of Ground Truth Used:
The ground truth for this device is based on objective measurements against established industry standards and regulatory requirements. This includes:
- Physical properties defined by ASTM D-5250-00E4 (e.g., dimensions, tensile strength, elongation).
- Barrier integrity (pinhole detection) verified by the FDA 1000 ml. Water Fill Test.
- Biocompatibility based on standardized biological tests for primary skin irritation and sensitization.
- Chemical residue (powder content) measured according to ASTM D6124-06.
8. The Sample Size for the Training Set:
This information is not applicable and not provided. This device is a manufactured product undergoing quality control and performance testing, not a machine learning model that requires a "training set."
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable. As explained above, there is no "training set" in the context of this device. The ground truth for evaluating the device's performance is established by the specified ASTM standards and FDA test methods.
§ 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.