(41 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, Powder-Free Vinyl Patient Examination Glove, 80L YZ, and meets all requirements of ASTM Standard D5250-00E4.
Here's a breakdown of the acceptance criteria and the study information based on the provided text, formatted as requested:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Physical and Dimensions Testing: Based on ASTM-D-5250-00E4, Inspection Level S-2, AQL 4.0 | Meets requirements |
| Pinhole Test (Water Fill Test): FDA 1000 ml. Water Fill Test based on ASTM D-5151-99, AQL 2.5, Inspection Level I | Meets requirements |
| Primary Skin Irritation: | No primary skin irritant reactions |
| Skin Sensitization (Allergic Contact Dermatitis): | No sensitization reactions |
| Residual Powder Test (for "powder-free" claim): Based on ASTM D6124-01 for Starch, no more than 2 mg powder per glove | Meets "powder-free" claims (contains no more than 2 mg powder per glove) |
2. Sample Size Used for the Test Set and Data Provenance
The document specifies "samplings of AQL 2.5, Inspection Level I" and "Inspection Level S-2, AQL 4.0" for the physical and pinhole tests. However, it does not explicitly state the exact numerical sample sizes used for these tests or for the biocompatibility tests (skin irritation and sensitization). The data provenance is not mentioned, but it can be inferred that the testing was conducted by or for Grand Work Plastics Products Co., Ltd., likely in China or through contracted labs. The data is presented as retrospective in nature, reflecting completed tests.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. This device is a patient examination glove, and the "ground truth" for its performance is established through standardized laboratory and biocompatibility tests, not expert consensus on medical images or diagnoses.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods are typically associated with subjective assessments or diagnostic interpretations by experts, which are not relevant for the type of testing performed on patient examination gloves.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human interpretation, which is not the case for patient examination gloves.
6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)
Yes, a standalone study was performed. The device's performance was evaluated through various non-clinical tests (physical, dimensional, pinhole, biocompatibility, residual powder) without human intervention in its function as a diagnostic aid. The study assesses the inherent properties and protective capabilities of the glove itself.
7. Type of Ground Truth Used
The ground truth used is based on:
- Standardized ASTM specifications: ASTM-D-5250-00E4 for physical and dimensional properties, ASTM D-5151-99 for pinhole, and ASTM D6124-01 for residual powder. These standards define objective, measurable criteria.
- Biocompatibility testing results: Ensuring no primary skin irritation or sensitization reactions, based on established toxicological principles.
8. Sample Size for the Training Set
Not applicable. This device does not involve machine learning or AI, so there is no concept of a "training set." The testing involved manufacturing samples directly.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this 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.