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Powder-Free Blue Nitrile Examination Glove is a disposable device intended for medical purposes that is worn on the examiner's hand or fingers to prevent contamination between Examiner and Patient. Tested for use with Chemotherapy Drugs as listed below.

Powder-Free Blue Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs.

The provided document describes the FDA 510(k) clearance for "Powder-Free Blue Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs" (K102623). It includes information about the indications for use and a table presenting the permeation times of various chemotherapy drugs through the gloves.

Based on the information provided, here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. A table of acceptance criteria and the reported device performance

The acceptance criteria for the gloves, specifically regarding chemotherapy drug permeation, are implicitly defined by the reported breakthrough detection times in minutes for a list of chemotherapy drugs. Although explicit "acceptance criteria" values are not stated (e.g., "must be greater than X minutes"), the table presents the performance of the device against these drugs. The key benchmark for acceptability appears to be practical protection during use.

Note regarding Carmustine: The document explicitly states, "Please note that Carmustine has an extremely low permeation time of less than 30 minutes." This acts as an important cautionary note, implying that while the glove was tested with Carmustine, its performance for this specific drug is significantly lower than for others and might not meet a reasonable expectation for prolonged protection during chemotherapy handling.

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 for Test Set: The document does not specify the sample size (i.e., how many gloves were tested for each chemotherapy drug). It only presents the breakthrough detection times.
• Data Provenance: The document does not explicitly state the country of origin of the data or whether the study was retrospective or prospective. Given that this is an FDA submission for a device manufactured by "PT. Medisafe Technologies JL. Batang Kuis GG. Tambak Rejo Desa Buntu Bedimbar TJ. Morawa Medan, North Sumatera Indonesia," it is highly probable that the testing was conducted either in Indonesia or at an accredited laboratory, but this is not confirmed by the document. The study would have been prospective to generate this performance data.

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 type of information is not applicable to this device. The "ground truth" for glove permeation is established through laboratory testing using standardized methods (e.g., ASTM F739 - Standard Test Method for Permeation of Liquids and Gases through Protective Clothing Materials under Conditions of Continuous Contact). It does not involve human experts or their consensus for establishing the data in the permeation table.

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

This information is not applicable to this device. Adjudication methods are typically used in studies involving subjective interpretation (e.g., radiology image reading). Glove permeation testing is an objective laboratory measurement.

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 information is not applicable to this device. An MRMC study is relevant for diagnostic devices that involve human interpretation, often assisted by AI. This is a protective barrier device, and its effectiveness is measured through physical and chemical property testing, not cognitive performance improvement.

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

This information is not applicable and is framed incorrectly for this device. A "standalone" performance refers to an AI algorithm's performance without human interaction. This device is a physical barrier; its performance is inherently standalone in the sense that its protective properties are measured intrinsically without human intervention in the permeation process itself.

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

The "ground truth" for the performance data presented is derived from objective laboratory testing using standardized chemical permeation methods. This involves measuring the time it takes for specific chemotherapy drugs to permeate through the glove material under controlled conditions. This is a scientific measurement, not based on expert consensus, pathology, or outcomes data.

8. The sample size for the training set

This information is not applicable to this device. "Training set" refers to data used to train machine learning models. This device is not an AI/ML device; its performance is based on intrinsic material properties.

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

This information is not applicable to this device, as there is no training set involved.

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