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510(k) Data Aggregation
(66 days)
SYNTHETIC (YELLOW) VINYL PATIENT EXAMINATION GLOVES-POWERED
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 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, and meets all requirements of ASTM Standard D5250-00E4.
Here's an analysis of the provided text regarding acceptance criteria and supporting studies for the Grand Work Plastics Products Co., Ltd. Synthetic (Yellow) Vinyl Patient Examination Gloves—Powdered:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria/Test | Reported Device Performance |
|---|---|---|
| Physical Properties | ASTM-D-5250-00E4 Standard (Physical and Dimensions Testing) | All testing meets requirements (Inspection Level S-2, AOL 4.0). |
| Barrier Integrity | FDA 1000 ml. Water Fill Test (based on ASTM D-5151-99) | Samplings met requirements (AQL 2.5, Inspection Level I). |
| Biocompatibility | Primary Skin irritation testing | No primary skin irritant reactions shown. |
| Biocompatibility | Skin Sensitization (allergic contact dermatitis) testing | No sensitization reactions shown. |
| Powder Content | Residual Powder Test (based on ASTM D6124-01 for Starch) | Conforms to "powdered" claims (contain no more than 10 mg/dm2). |
| Overall Conformance | ASTM-D-5250-00E4 Standard | Conforms fully. |
| Overall Conformance | Applicable 21 CFR references | Conforms fully. |
| Overall Conformance | Pinhole FDA requirements | Meets requirements. |
| Overall Conformance | Biocompatibility requirements | Meets requirements. |
| Overall Conformance | Labeling claims | Meets claims. |
2. Sample Size Used for the Test Set and Data Provenance
The document explicitly mentions sample sizes and inspection levels where applicable:
- Physical and Dimensions Testing (ASTM-D-5250-00E4): Inspection Level S-2. AQL 4.0.
- FDA 1000 ml. Water Fill Test (ASTM D-5151-99): Samplings of AQL 2.5, Inspection Level I.
Provenance: The tests were conducted by the manufacturer, Grand Work Plastics Products Co., Ltd., in China, as part of their production and quality control processes to ensure compliance with ASTM standards. The data is retrospective, as it relates to the evaluation of the device against established standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. The ground truth for these tests is established by published, internationally recognized consensus standards (ASTM and FDA test methods), not by individual expert interpretation of complex clinical cases or images. The "experts" would be the technical committees that develop and validate these standards.
4. Adjudication Method for the Test Set
Not applicable. As the tests involve objective measurements against predefined acceptance criteria from standards (e.g., AQL levels for physical properties and water fill tests, quantitative limits for residual powder, and observable skin reactions for biocompatibility), there is no need for a subjective adjudication method like 2+1 or 3+1. The results are compared directly to the specified benchmarks.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic or screening devices where the performance involves human interpretation of results, often with AI assistance. For patient examination gloves, the performance evaluation is based on objective physical, chemical, and biological tests, not reader-dependent assessments.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, in a way, the entire testing regimen described can be considered "standalone" as it evaluates the inherent properties of the gloves themselves without human interaction during the functional assessment. The tests are designed to measure the intrinsic characteristics and performance of the glove material and construction. There is no "algorithm" in the context of AI, but the manufacturing and testing processes are designed to produce a standalone product meeting specifications.
7. The Type of Ground Truth Used
The ground truth used is primarily based on:
- Consensus Standards: Specifically, ASTM Standard D5250-00E4 for physical properties and dimensions, ASTM D-5151-99 for water leak testing, and ASTM D6124-01 for residual powder content.
- Regulatory Requirements: FDA requirements for pinhole integrity and general biocompatibility.
- Observation/Measurement: Direct observation for skin irritation and sensitization.
8. The Sample Size for the Training Set
Not applicable. This device is a physical product (patient examination gloves), not a machine learning or AI algorithm that requires a training set of data.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device.
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