Search Results

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.

Ask a specific question about this device

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.

Two subject devices are bundled into this 510(k) submission. The subject devices, the Nitrile Powder Free Examination Gloves and the Chemotherapy Nitrile Powder Free Examination Gloves, are single use, disposable devices intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. The gloves are made of nitrile rubber, powder free, ambidextrous with beaded cuff and tested for use with chemotherapy drugs. 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 two subject devices proposed are identical in terms of sizes, materials, color, specification, and process. The only difference between the two is the chemotherapy drug labeling.

The provided document is a 510(k) summary for Nitrile Powder Free Examination Gloves and Chemotherapy Nitrile Powder Free Examination Gloves. It details the non-clinical tests performed to demonstrate substantial equivalence to a predicate device.

Crucially, this document is for a Class I medical device (gloves) and explicitly states that "Clinical data is not required for marketing clearance of patient examination gloves." Therefore, there are no acceptance criteria, study details, sample sizes, expert involvement, adjudication methods, MRMC studies, or standalone algorithm performance related to an AI/ML device as none of this applies to the product described.

Instead, the document focuses on demonstrating that the gloves meet established performance standards for physical properties, barrier integrity, and biocompatibility.

Here's an analysis based on the information provided, specifically highlighting why the requested AI/ML-related information is absent and what was evaluated:

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

The document provides tables of non-clinical tests and their requirements, which serve as the acceptance criteria for these physical and chemical properties.

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

The document does not explicitly state the sample sizes used for each specific non-clinical test (e.g., how many gloves were tested for watertightness, or how many samples for biocompatibility). The tests are standardized (ASTM, ISO), meaning they have established sample size requirements for their methodologies, but the specific numbers are not presented in this summary.

Data provenance: The tests were performed by the manufacturer (KL-Kepong Rubber Products Sdn. Bhd. in Malaysia) or accredited labs they contracted. The data is prospective, generated specifically for this submission.

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

Not applicable. This is not an AI/ML device; therefore, there is no "ground truth" to be established by experts in the context of clinical interpretation or diagnosis. The ground truth for these device properties is based on adherence to established international (ISO) and national (ASTM) standards and laboratory testing protocols.

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

Not applicable. There is no subjective interpretation or diagnostic outcome to adjudicate for this type of device. The tests are objective and quantitative measurements against predefined specifications.

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 (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for this device's performance is objective and defined by established industry and regulatory standards for physical properties (e.g., dimensional measurements, tensile strength, elongation, freedom from holes, residual powder) and chemical resistance/biocompatibility via standardized testing protocols (e.g., ASTM D6978 for chemotherapy drug permeation, ISO 10993 for biocompatibility).

8. The sample size for the training set

Not applicable. This is not an AI/ML device; there is no "training set."

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

Not applicable. This is not an AI/ML device.

Ask a specific question about this device

A powder-free patient examination glove is a disposable device made of natural rubber latex or synthetic material that may bear a trace amount of glove powder and is intended to be worn on the hand or finger(s) for medical purposes to provide a barrier against potentially infections materials and other contaminants.

POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVES WITH PROTENCED OD IMER CORTED LATEX EXAMINA HON GLOVES

Here's an analysis of the provided text regarding the acceptance criteria and study for the device:

The provided text is a 510(k) premarket notification letter from the FDA to KL Kepong Rubber Products Sdn Bhd, concerning "Powder Free Polymer Coated (Acrylic Based) Latex Patient Examination Gloves with Protein Content Labeling Claim (50 Micrograms or Less)."

This document does not contain the specific information required to complete your request. It is an FDA clearance letter confirming that the device is substantially equivalent to legally marketed predicate devices, meaning it doesn't need a Premarket Approval (PMA) application. This letter does not include details about device performance, acceptance criteria, or specific studies conducted to prove the device meets performance criteria.

Therefore, I cannot provide the requested information from the given text.

To elaborate on why each point cannot be addressed:

1. A table of acceptance criteria and the reported device performance: This letter only states the device is "substantially equivalent" to predicate devices. It doesn't list specific performance metrics or their acceptance thresholds.
2. Sample sized used for the test set and the data provenance: There is no mention of any test set size or where the data came from.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Ground truth establishment and expert details are not part of this type of regulatory clearance letter.
4. Adjudication method: Not mentioned.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: MRMC studies are typically for diagnostic devices or AI algorithms where reader performance is a key metric. This is a physical glove, so an MRMC study would not be applicable in this context.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: This pertains to AI algorithms, which is not what this device is.
7. The type of ground truth used: Not mentioned, and generally not applicable for a physical barrier device like a glove in this context.
8. The sample size for the training set: This refers to AI algorithms; not applicable here.
9. How the ground truth for the training set was established: This refers to AI algorithms; not applicable here.

In summary, the provided document is a regulatory approval letter and does not contain the detailed study results or acceptance criteria you're looking for. Such information would typically be found in the 510(k) submission itself (the "premarket notification") rather than the FDA's response letter.

Ask a specific question about this device