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510(k) Data Aggregation
(44 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 A patient 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.
Here's a breakdown of the acceptance criteria and study information based on the provided text, focusing on the Powder Free Vinyl Patient Examination Gloves:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard) | Test Method/Requirement | Reported Device Performance |
|---|---|---|
| ASTM D-5250-00E4 | Physical and dimensions testing | "All testing meets requirements for physical and dimensions testing conducted on gloves." |
| FDA 1000 ml. Water Fill Test | AQL 2.5, Inspection Level I | "Meeting these requirements." (Implies meeting AQL 2.5, Inspection Level I) |
| Primary Skin Irritation | No primary skin irritant reactions | "No primary skin irritant reactions." |
| Skin Sensitization | No sensitization reactions (allergic contact dermatitis) | "No sensitization reactions." |
| Residual Powder Content | ASTM D-6124-06 (target: no more than 2 mg powder per glove) | "Insure that our gloves meet our 'powder-free' claims (contain no more than 2 mg powder per glove)." |
| Pinhole Requirements | FDA requirements | "Meets pinhole FDA requirements." |
| Biocompatibility | (Implied by skin irritation/sensitization tests) | "Meets biocompatibility requirements." |
2. Sample Sizes and Data Provenance
- Test Set Sample Size: For the ASTM D-5250-00E4 physical and dimensions testing, the inspection level was S-2, AQL 4.0. For the FDA 1000 ml. Water Fill Test, the inspection level was I, AQL 2.5. The exact number of units sampled for each test is not explicitly stated, but these AQL (Acceptable Quality Level) values dictate the sampling plan.
- Data Provenance: The testing was conducted by Super Safe Plastic Products Co., Ltd. in China. The data is retrospective, as it describes tests performed on the manufactured gloves.
3. Number of Experts and Qualifications for Ground Truth
This information is not applicable to this type of device. The ground truth for performance of examination gloves is established through standardized physical, chemical, and biological tests, not through expert human interpretation or consensus.
4. Adjudication Method for the Test Set
This is not applicable as the performance is measured purely through objective, standardized tests, not subjective interpretations requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
This is not applicable. This type of study is used for diagnostic or screening devices where human readers interpret results, and the AI's impact on their performance is being evaluated. This device is a patient examination glove.
6. Standalone (Algorithm Only) Performance Study
This is not applicable. This device does not involve an algorithm or software. Its performance is determined by its physical and material properties.
7. Type of Ground Truth Used
The ground truth used for this device's acceptance is based on:
- Standardized Test Methods and Criteria: Specifically, ASTM D-5250-00E4 and ASTM D-6124-06 for physical properties and residual powder, and FDA requirements for water fill/pinholes, skin irritation, and sensitization. These standards define the objective measures for performance.
8. Sample Size for the Training Set
This is not applicable. This device does not use machine learning or algorithms, so there is no "training set."
9. How the Ground Truth for the Training Set was Established
This is not applicable for the same reason as above; there is no training set.
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