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510(k) Data Aggregation
(80 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 a disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner (21CFR 880.6250)
Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Powder-Free Vinyl Patient Examination Glove, 80LYZ. and meets all requirement of ASTM Standard D5250-06.
The provided text describes the acceptance criteria and study for Shijiazhuang Fuhao Plastic Products Co., Ltd. Synthetic Vinyl Patient Examination Gloves -- Powder Free. It does not pertain to an AI/ML device, but rather a medical glove. Therefore, most of the requested fields related to AI/ML studies (such as MRMC studies, standalone algorithm performance, AI assistance effect size, training set details, and expert qualifications for ground truth) are not applicable to this document.
Here's the information that can be extracted from the provided text for this specific device:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|
| ASTM Standard D5250-06 | Device meets all requirements of ASTM Standard D5250-06. |
| Pinhole Defect Rate (FDA 1000 ml. Water Fill Test) | Meets requirements with Inspection Level I, AQL 2.5. (Implies meeting the established AQL for pinholes, likely 2.5% or lower). |
| Primary Skin Irritation | No primary skin irritant reactions. |
| Skin Sensitization (Allergic Contact Dermatitis) | No sensitization reactions. |
| Powder-Free (≤ 2 mg powder per glove) | Meets "powder-free" claims (contains no more than 2 mg powder per glove). |
| Biocompatibility | Meets biocompatibility requirements. |
| Physical and Dimensions Testing | Meets requirements for Physical and Dimensions Testing. |
| Labeling Claims | Meets labeling claims. |
| 21 CFR 880.6250 (General Controls) | Conforms fully to applicable 21 CFR references. |
2. Sample size used for the test set and the data provenance
- Sample Size: The document mentions "Inspection Level S-2. AOL 2.5" for Physical and Dimensions Testing, and "samplings of AOL 2.5. Inspection Level I" for the FDA 1000 ml. Water Fill Test. These refer to Acceptable Quality Limit (AQL) sampling plans, which are industry standards. They don't specify an exact number of units, but rather the statistical sampling method used. The "AQL 2.5" implies that, on average, no more than 2.5% of the sampled units would be defective to pass.
- Data Provenance: The tests were conducted by the manufacturer, Shijiazhuang Fuhao Plastic Products Co., Ltd., in China. The data would be considered prospective as it's part of the manufacturing quality control process for the specific device being submitted for clearance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This device is a medical glove, and the "ground truth" is established through standardized physical and chemical testing, not expert interpretation of outputs like in AI/ML.
4. Adjudication method for the test set
Not applicable. Testing is based on objective measurements and established standards (e.g., pass/fail for water leak, specified powder limits), not on subjective interpretation requiring 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
Not applicable. This is not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML device.
7. The type of ground truth used
The ground truth is based on objective measurements and adherence to established industry standards (ASTM D5250-06) and regulatory requirements (FDA's 1000 ml Water Fill Test, biocompatibility tests). This includes physical properties (dimensions, strength), chemical properties (powder content), and biological reactions (skin irritation, sensitization).
8. The sample size for the training set
Not applicable. This is not an AI/ML device, so there is no "training set." The manufacturing process itself is akin to the "training" in a general sense of producing a product that meets specifications, but not in the context of machine learning.
9. How the ground truth for the training set was established
Not applicable. There is no training set as this is not an AI/ML device.
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