Search Results

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.

NON-STERILE GREEN COLORED POWDERED LATEX PATIENT EXAMINATION GLOVES WITH & WITHOUT SOUR APPLE/PEPPERMINT SCENTS AND WITH A PROTEIN LABELING CLAIM (<200ug/g) Contains 200 migm or less of for at Water Extractable

The provided text describes the acceptance criteria and performance data for "NON-STERILE GREEN COLORED POWDERED LATEX PATIENT EXAMINATION GLOVES WITH & WITHOUT SOUR APPLE/PEPPERMINT SCENTS AND WITH A PROTEIN LABELING CLAIM (<200ug/g)".

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for the Test Set and Data Provenance

• Tensile Strength & Ultimate Elongation: The data is presented by glove size (X-SMALL, SMALL, MEDIUM, LARGE) for one "LOT # 0238". The specific number of gloves tested for each measurement (tensile strength and elongation) is not explicitly stated.
• Water Tight Test: "SAMPLING SIZE" is listed as 125 gloves for each size (XS, S, M, L) for both unaged and aged samples, totaling 1000 gloves (4 sizes * 2 conditions * 125 gloves/sample).
• Residual Protein Level: No specific sample size is mentioned for the protein level testing, but a range and mean are provided.
• Data Provenance: The document does not specify the country of origin for the data. The data appears to be from internal testing by SGMP (SGMP ASTM) and is retrospective, conducted to support the 510(k) submission.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts

Not applicable. This device is a physical product (gloves), and performance is determined by objective physical and chemical testing against established standards (ASTM-D3578-01aE2, ASTM D 5712-99) and FDA allowable levels. Expert consensus for ground truth is not relevant in this context.

4. Adjudication Method for the Test Set

Not applicable. Performance is based on direct measurement and comparison to predefined ASTM standards and AQL limits for physical properties and chemical composition. There is no human judgment involved that would require an adjudication method.

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 relevant for diagnostic devices that involve human interpretation of medical images or data. The device in question is a patient examination glove.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a physical product (gloves), not an algorithm or software. Its performance is assessed through laboratory testing.

7. The Type of Ground Truth Used

The ground truth used for this device's performance evaluation is based on:

• ASTM Consensus Standards: Specifically, ASTM-D3578-01aE2 for Physical Properties (Tensile Strength, Ultimate Elongation, Water Tight Test) and ASTM D 5712-99 for Residual Protein Level. These are widely accepted industry standards for latex examination gloves, established through a consensus process by experts in the field.
• Regulatory Limits: The FDA's allowable level for total extractable protein (< 200 µg/g) serves as a regulatory ground truth for this claim.

8. The Sample Size for the Training Set

Not applicable. This device is a physical product and its performance validation relies on direct testing against established standards, not on machine learning or AI models that require training sets.

9. How the Ground Truth for the Training Set was Established

Not applicable, as there is no training set for this type of device.

Ask a specific question about this device