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A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

These gloves were tested for use with chemotherapy drugs, fentanyl citrate and gastric acid as per ASTM D6978-05 (2023) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs:

The following drugs and concentration had NO breakthrough detected up to 240 minutes:

• Bendamustine HCl (5 mg/mL)
• Bleomycin Sulfate (15 mg/mL)
• Busulfan (6 mg/mL)
• Carboplatin (10 mg/mL)
• Carfilzomib (2 mg/mL)
• Cetuximab (Erbitux) (2 mg/mL)
• Chloroquine (50 mg/mL)
• Cisplatin (1 mg/mL)
• Cladribine (1 mg/mL)
• Cyclophosphamide (20 mg/mL)
• Cyclosporin A (100 mg/mL)
• Cytarabine HCl (100 mg/mL)
• Cytovene (10 mg/mL)
• Dacarbazine (10 mg/mL)
• Daunorubicin HCl (5 mg/mL)
• Decitabine (5 mg/mL)
• Docetaxel (10 mg/mL)
• Doxorubicin HCl (2 mg/mL)
• Epirubicin HCl (2 mg/mL)
• Etoposide (20 mg/mL)
• Fludarabine Phosphate (25 mg/mL)
• Fluorouracil (50 mg/mL)
• Fulvestrant (50 mg/mL)
• Gemcitabine HCl (38 mg/mL)
• Idarubicin HCl (1 mg/mL)
• Ifosfamide (50 mg/mL)
• Irinotecan HCl (20 mg/mL)
• Mechlorethamine HCl (1 mg/mL)
• Melphalan HCl (5 mg/mL)
• MESNA (100 mg/mL)
• Methotrexate (25 mg/mL)
• Mitomycin C (0.5 mg/mL)
• Mitoxantrone HCl (2 mg/mL)
• Oxaliplatin (2 mg/mL)
• Paclitaxel (6 mg/mL)
• Pemetrexed (25 mg/mL)
• Propofol (10 mg/mL)
• Raltitrexed (0.5 mg/mL)
• Retrovir (10 mg/mL)
• Rituximab (10 mg/mL)
• Temsirolimus (25 mg/mL)
• Topotecan HCl (1 mg/mL)
• Triclosan (1 mg/mL)
• Trisenox (Arsenic Trioxide) (1 mg/mL)
• Velcade (Bortezomib) (1 mg/mL)
• Vidaza (Azacitidine) (25 mg/mL)
• Vinblastine Sulfate (1 mg/mL)
• Vincristine Sulfate (1 mg/mL)
• Vinorelbine Tartrate (10 mg/mL)
• Zoledronic Acid (0.8 mg/mL)

The following chemotherapy drugs and concentration showed breakthrough detected in less than 60 minutes:

• Carmustine (3.3 mg/mL), breakthrough detected at 55.5 minutes
• Thiotepa (10 mg/mL), breakthrough detected at 50.8 minutes

Warning: Not recommended for use with Carmustine and Thiotepa

The following hazardous drugs (opioids) and concentration had NO breakthrough detected up to 240 minutes:

• Fentanyl Citrate Injection (100mcg/2mL)
• Simulated Gastric Acid Fluid/Fentanyl Citrate Injection Mix 50/50 Solution

The subject device, Nitrile Powder Free Examination Gloves with Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid is a single use, disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. This product demonstrated reduced potential for sensitizing users to chemical additives, supported by a negative skin sensitization test (Modified Draize-95 Test) and tested for use with chemotherapy drugs, fentanyl citrate and gastric acid.

The gloves are made of nitrile rubber, powder free, ambidextrous with beaded cuff. Inner surface of gloves undergoes surface treatment process to produce a smooth surface that facilitates the user in donning the gloves without using lubricant and donning powder on the glove surface. These gloves are offered in six sizes (XS, S, M, L, XL, XXL), and supplied in non-sterile state.

The provided FDA 510(k) clearance letter and summary concern a medical device, "Nitrile Powder Free Examination Gloves with Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid." This document details the product's attributes, testing, and comparison to a predicate device for regulatory clearance.

However, the questions you've asked (acceptance criteria, study details, sample sizes, expert qualifications, adjudication, MRMC studies, standalone performance, ground truth, and training set details) are highly specific to the performance of an AI/ML medical device rather than a physical product like examination gloves. The provided document describes the physical and chemical performance of the gloves (e.g., resistance to permeation by chemotherapy drugs, physical properties, biocompatibility, and skin sensitization), not the performance of an artificial intelligence or machine learning algorithm.

Therefore, many of your questions are not applicable to the information contained within this 510(k) clearance for medical gloves. I will answer the applicable questions based on the provided text, and explicitly state when a question is not relevant to this type of device.

Acceptance Criteria and Device Performance for Nitrile Examination Gloves

The "acceptance criteria" for these gloves are primarily physical, chemical, and biological performance standards, as demonstrated through various ASTM and ISO tests. The "reported device performance" indicates whether the gloves met these pre-defined standards.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample sizes used for the test set and the data provenance

• Chemotherapy Drugs Permeation Test (ASTM D6978-05): The document does not explicitly state the sample size (number of gloves tested) for the permeation tests, but ASTM standards typically specify these per test. The data provenance is implied to be from laboratory testing as per the ASTM standard. The document does not specify country of origin for the data (beyond the applicant being from Malaysia). This would be a prospective experimental study in a lab setting, not a retrospective or prospective clinical data collection.
• Clinical Sensitization Test (Modified Draize-95 Test):
  • Sample Size: 209 non-sensitized human subjects (inner surface) and 200 non-sensitized human subjects (outer surface).
  • Data Provenance: This was a prospective clinical test on human subjects. The document does not explicitly state the country of origin for these subjects.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This question is not applicable to this type of device. "Ground truth" established by human experts (e.g., radiologists, pathologists) is relevant for AI/ML device studies where an algorithm is interpreting complex, subjective data (like medical images). For medical gloves, the "ground truth" is established by adherence to physical, chemical, and biological performance standards measured using established laboratory protocols (e.g., ASTM, ISO). There are no "experts" creating a subjective ground truth for a test set in the way there would be for an AI diagnostic device. The results are objective measurements.

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

Not applicable. Adjudication methods are used in AI/ML studies to resolve discrepancies among expert readers establishing ground truth. For the physical and chemical tests of medical gloves, the results are objective measurements, not subjective interpretations 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. An MRMC study is relevant for AI/ML devices where the AI is intended to assist human readers (e.g., radiologists interpreting images). This device is a physical product (gloves) and does not involve human readers or AI assistance.

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

Not applicable. "Standalone performance" refers to the algorithm's performance without human intervention. This device is a physical product.

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

The "ground truth" for this device's performance is tied to objective measurements against established industry standards and validated laboratory test methods. This includes:

• Physical properties (e.g., tensile strength, elongation, dimensions) measured according to ASTM D6319-19.
• Barrier integrity (freedom from holes) measured according to ASTM D5151-19.
• Chemical permeation resistance measured according to ASTM D6978-05.
• Biocompatibility assessments (skin sensitization, systemic toxicity, irritation) performed according to ISO 10993 series.
• Clinical skin sensitization test (Modified Draize-95 Test) observing actual human subject responses.

Therefore, the "ground truth" is based on controlled experimental and clinical testing data demonstrating adherence to pre-defined performance specifications derived from recognized standards.

8. The sample size for the training set

This question is not applicable as this is not an AI/ML device. "Training set" refers to data used to train an AI algorithm. The manufacturing process for gloves is not "trained" using a data set in this manner.

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

Not applicable, as this is not an AI/ML device.

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