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The Non-Sterile, Powder-Free, Latex Examination Gloves with Lanolin and Vitamin E Coating, Green and with Protein Labeling Claim (50 micrograms or less total water extractable protein per gram of glove), is a disposable device intended for Medical Purposes that is worn on the examiners hand to prevent contamination between patient and examiner.

Non-Sterile, Powder-Free, Latex Examination Gloves with Lanolin and Vitamin E Coating, Green and with Protein Labeling Claim

Here's a breakdown of the acceptance criteria and the study information for the "Non-Sterile, Powder-Free, Latex Examination Gloves with Lanolin and Vitamin E Coating, Green and with Protein Labeling Claim," based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The reported device performance often states "minimum" or "maximum" values that align with the acceptance criteria, suggesting the device met or exceeded these thresholds. For inspection parameters, the text states "In compliance with ASTM D3578-10.ISO 2859-1:1999" and lists the AQLs, implying the device met these standards through the specified inspection levels.

The provided text describes a 510(k) premarket notification for a medical device (examination gloves). This type of submission focuses on demonstrating substantial equivalence to a previously legally marketed device (predicate device), rather than a detailed clinical study proving efficacy in the same way a new drug or novel high-risk device might. Therefore, many of the typical questions for a "study that proves the device meets acceptance criteria" are not directly applicable or are answered implicitly through the regulatory framework.

Here's a breakdown of the other requested information based on the provided text:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size: The document does not specify a distinct "test set" sample size in terms of the number of gloves tested for each criterion. Instead, it refers to industry standards (ASTM D3578-10, ISO 2859-1:1999) and inspection levels (S-2, G-1) with Acceptance Quality Limits (AQLs). These standards inherently define the sampling plans used for quality control testing.
• Data Provenance: The manufacturer is "UG Global Resources Sdn Bhd 181 Floor No. 18 Jalan Dato' Abd Rahman 70000 Seremban Malaysia." This indicates the testing and data likely originated from Malaysia. The study is prospective in nature, as it involves testing the manufactured gloves to ensure they meet the defined specifications before market release.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• This question is not applicable to this type of device and submission. The "ground truth" for examination gloves is defined by adherence to established engineering and material science standards (ASTM, ISO), manufacturing quality control processes, and biocompatibility testing, not by expert consensus on clinical interpretation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• This question is not applicable. Adjudication methods like 2+1 or 3+1 are used for interpreting subjective data, typically in clinical trials involving image analysis or symptom assessment. The tests performed on these gloves are objective physical and chemical measurements.

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

• This question is not applicable. MRMC studies are used for evaluating diagnostic devices, particularly those involving human interpretation (e.g., radiology AI). This device is an examination glove, which does not involve "readers" or "AI assistance."

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

• This question is not applicable. This device is a physical product, not an algorithm, and does not involve AI or standalone algorithmic performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• The "ground truth" for the performance of these gloves is based on:
  • Established Industry Standards: Primarily ASTM D3578-10 for physical properties and ISO 2859-1:1999 for quality assurance.
  • FDA 1000 ml water test: A specific regulatory test for watertight integrity.
  • Biocompatibility Test Results: To ensure safety in contact with skin.
  • Residual Powder Contents tests: To verify "powder-free" claim.
  • Protein Labeling Claim Level: Chemical testing to quantify protein levels.

8. The sample size for the training set

• This question is not applicable. "Training sets" are relevant for machine learning algorithms. For manufactured goods like gloves, there isn't a "training set" in this context. The manufacturing process is designed and monitored to consistently produce gloves meeting specifications, and ongoing quality control (using the stated inspection levels and AQLs) ensures this.

9. How the ground truth for the training set was established

• This question is not applicable as there is no "training set" in the context of this device. The "ground truth" for acceptable glove performance is established by the specifications themselves, derived from regulatory requirements and industry standards.

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