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Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue); and Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) - Extended Cuff, is a sterile disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.

These gloves were tested for use with chemotherapy drugs and fentanyl citrate as per ASTM D6978 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.

Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) and Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) – Extended Cuff, are disposable, single-use, sterile, blue-colored, and powder-free examination gloves made from nitrile latex.

The provided FDA 510(k) clearance letter pertains to medical examination gloves, not an AI-powered medical device. Therefore, the document does not contain information about the acceptance criteria and study proving an AI device meets those criteria.

The information typically found in such a submission would include:

• Device performance: This document explicitly states the "Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue)" has been tested for resistance to permeation by chemotherapy drugs and fentanyl citrate as per ASTM D6978 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.
• Acceptance Criteria/Performance Data: The acceptance criteria for the gloves are based on relevant ASTM standards for physical properties, barrier integrity, and biocompatibility. The chemotherapy drug resistance is presented as "Minimum Breakthrough Detection Time in Minutes."
• Study Design (Non-Clinical): The studies are non-clinical, primarily laboratory-based physical and chemical tests compliant with recognized international and national standards (e.g., ASTM, ISO).
• Ground Truth: For these types of devices, the "ground truth" is typically defined by quantifiable physical and chemical properties measured against established standard methods (e.g., measuring milligrams of residual powder, breakthrough time of chemicals). There are no human experts, adjudication, or training/test sets in the context of AI for this type of device.

Given this, I cannot extract the information required for an AI-powered device from this document. The sections you asked for (sample size for test/training, expert qualifications, MRMC studies, standalone performance, etc.) are specific to AI/software as a medical device (SaMD) assessments and are not present in a submission for examination gloves.

However, I can summarize the acceptance criteria and reported performance for the examination gloves as provided in the document:

Acceptance Criteria and Reported Device Performance (for Examination Gloves)

This table summarizes the non-clinical acceptance criteria and the "result" or reported performance for the Sterile Nitrile Powder Free Examination Gloves.

Chemotherapy Drug and Fentanyl Citrate Permeation Results

Device Performance (Minimum Breakthrough Detection Time in Minutes)

Since the provided document is not for an AI device, the following points cannot be addressed:

• Sample sized used for the test set and the data provenance: Not applicable to a physical glove.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for gloves is based on physical/chemical measurements by laboratory technicians following standard protocols.
• Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
• 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.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For gloves, it's objective physical/chemical measurements according to ASTM/ISO standards.
• The sample size for the training set: Not applicable (no AI training involved).
• How the ground truth for the training set was established: Not applicable.

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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

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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 and Fentanyl Citrate as per ASTM D6978-05 (2023), Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs:

Warning: Do not use with Carmustine and Thiotepa.

Note:
Please note that the following drugs have low permeation times:
(1) Carmustine - 22.5 minutes
(2) Thiotepa - 34.5 minutes.

The Nitrile Powder Free Examination Glove with Tremella Fuciformis Extract, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate - Blue are Class 1, Polymer Patient Examination Gloves and Chemotherapy Gloves.

The glove is made of Nitrile Butadiene Rubber. They are ambidextrous with beaded cuffs, fingertip texture and come in different sizes - Small, Medium, Large and Extra Large. Gloves meet the specification of ASTM D6319-19 and have been tested for resistance to permeation by chemotherapy drugs and fentanyl citrate as per ASTM D6978-05(2023). The gloves are single use and provided non-sterile.

The provided FDA 510(k) clearance letter pertains to Nitrile Powder Free Examination Gloves, not a software-based medical device or AI system. Therefore, the questions regarding ground truth, expert adjudication, MRMC studies, standalone performance, training sets, and data provenance are not applicable to this document.

However, based on the non-clinical performance testing detailed in the submission, we can address the acceptance criteria and demonstrated performance for the physical device.

Acceptance Criteria and Reported Device Performance for Nitrile Powder Free Examination Gloves K243694

The acceptance criteria for this medical device are based on various physical, chemical, and biological tests, primarily adhering to ASTM and ISO standards for examination gloves and their specific claims (chemotherapy and fentanyl resistance).

1. Table of Acceptance Criteria and the Reported Device Performance

2. Sample size used for the test set and the data provenance:

The document does not explicitly state the specific "sample size" for each individual test reported (e.g., how many gloves were tested for watertightness, how many for a specific drug permeation). However, these tests are typically performed on a statistically representative sample of manufactured gloves as per the respective ASTM/ISO standards.

• Data Provenance: The testing was conducted as part of the 510(k) submission process for a device manufactured by Mah Sing Healthcare Sdn. Bhd. in Malaysia. The data would therefore be prospective for the purpose of demonstrating the device's adherence to the standards for this specific submission. The data is generated from laboratory testing of the physical product.

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

Not applicable. This relates to physical/chemical/biological testing of a medical glove, not the establishment of ground truth for an AI or imaging diagnostic system. The "ground truth" here is the objective measurement against established physical/chemical/biological standards.

4. Adjudication method for the test set:

Not applicable. Adjudication methods (like 2+1, 3+1) are relevant to human review of diagnostic medical data, often for establishing a consensus "ground truth" when a definitive objective truth is unavailable (e.g., interpreting medical images). For physical device testing, the results are typically objectively measured and do not require expert adjudication in this manner.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

No. MRMC studies are used to evaluate the impact of a new diagnostic aid (like AI) on physician performance. This is for a physical medical device (examination gloves), not an AI system or diagnostic tool.

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

Not applicable. This question pertains to AI algorithm performance.

7. The type of ground truth used:

Objective Experimental Measurement and Compliance with Standardized Protocols. For each test (e.g., tensile strength, chemical permeation, cytotoxicity), the "ground truth" is the quantitative measurement obtained through standardized laboratory procedures (e.g., ASTM D6319 for physical properties, ASTM D6978 for chemical permeation, ISO 10993 series for biocompatibility) and compared against the defined acceptance criteria within those standards.

8. The sample size for the training set:

Not applicable. This question pertains to AI/machine learning models. Examination gloves do not have a "training set."

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

Not applicable. Again, this relates to AI/machine learning.

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An examination glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. These gloves were tested for use with chemotherapy drugs with Gastric Acid, Xylazine and Fentanyl Citrate in accordance with ASTM D6978-05 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs. chemotherapy drugs; Gastric Acid; Xylazine; Fentanyl

Nitrile Powder Free Examination Glove, Blue Tested for Use with 60 Chemotherapy Drugs, Gastric Acid, Xylazine and Fentanyl

This document is a 510(k) clearance letter for a medical device: "Nitrile Powder Free Examination Glove, Blue Tested for Use with 60 Chemotherapy Drugs, Gastric Acid, Xylazine and Fentanyl". This type of device is a physical barrier and does not involve AI or imaging analysis, which are the typical contexts for the detailed acceptance criteria and study designs you've requested.

Therefore, many of the specific questions you've asked, such as those related to AI algorithm performance (e.g., sample size for training set, number of experts for ground truth, MRMC studies) are not applicable to this device.

However, I can extract the closest analogous information from the provided text about the device's performance against its stated "Indications for Use," which serves as its functional acceptance criteria.

Understanding the Device and its "Acceptance Criteria":

The device is a medical glove. Its primary "acceptance criteria" are related to its ability to prevent permeation by various substances, specifically:

• 60 chemotherapy drugs
• Gastric Acid
• Xylazine
• Fentanyl Citrate

The reported "device performance" is measured by the "Minimum Breakthrough Detection Time (Min.)" when tested according to ASTM D6978-05. The acceptance criterion implied for most tested substances is "no breakthrough detected up to 240 minutes" (i.e., >240 minutes). For two specific drugs, Carmustine and Thiotepa, the breakthrough times are explicitly lower (11 minutes and 39 minutes, respectively), and the label includes a warning that these should not be used with these drugs.

Here's the information parsed from the document, addressing your questions where applicable, and stating "Not Applicable" (N/A) for those that don't fit the context of a physical barrier device or an AI/imaging study:

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

For most substances, the implied acceptance criterion is "no breakthrough detected up to 240 minutes". The reported performance generally meets this, with specific exceptions noted.

Note: The "acceptance criterion" column for Carmustine and Thiotepa is marked N/A because the device performance is clearly below the general threshold of >240 minutes, and instead, the clearance document acknowledges this lower performance and specifies a warning against their use. This means the device is cleared despite not meeting the >240 min criterion for these two specific chemicals, but with a critical warning to users.

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

• Sample Size: Not specified in the provided text. The testing was conducted according to ASTM D6978-05, which would stipulate the required sample sizes for such tests, but the specific number used for this device is not reported.
• Data Provenance: The manufacturer is "GMP Medicare Sdn. Bhd." located in Malaysia. The testing methodology (ASTM D6978-05) is an international standard. Whether the testing was performed in Malaysia or another country is not specified, nor is whether the data is retrospective or prospective, though performance testing for device clearance is typically prospective by nature.

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

• N/A. This device is a physical barrier. "Ground truth" in this context is established by objective laboratory testing (permeation time using analytical methods), not by human expert interpretation (like radiologists for medical images).

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

• N/A. Adjudication methods like 2+1 or 3+1 are used for establishing consensus among human annotators/experts, typically in medical imaging or clinical trials. The "test set" here refers to physical samples of gloves subjected to a standardized chemical permeation test. The results are quantitative and objectively measured.

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

• N/A. This is a physical device, not an AI-assisted diagnostic tool. No human "readers" or AI assistance are involved in its primary function or testing for this clearance.

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

• N/A. This is a physical device, not an algorithm.

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

• Objective laboratory measurement/Chemical Permeation Testing: The "ground truth" for this device's performance is the direct measurement of breakthrough time using the standardized ASTM D6978-05 method. This involves analytical detection of the permeating substance on the non-contact side of the glove.

8. The sample size for the training set

• N/A. This is a physical device. There is no "training set" in the context of machine learning. Design and development of the glove material (e.g., nitrile composition) would involve material science and manufacturing processes, but not a machine learning training set.

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

• N/A. As above, no training set for an algorithm is involved.

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Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) is a nonsterile disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. It is also tested to be used against Chemotherapy Drugs and Fentanyl Citrate.

Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) is a disposable single-use, non- sterile, blue-colored and powder-free examination glove made from nitrile latex. Gloves meet the specification of ASTM D6319-19 and have been tested for resistance to permeation by chemotherapy drugs and fentanyl citrate as per ASTM D6978-05(2019).

The provided text is a 510(k) Premarket Notification from the FDA for a medical device: "Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue)".

This document does not describe the acceptance criteria or a study related to an AI/ML powered device. Instead, it details the testing and comparison of a physical medical device (gloves) against a predicate device, focusing on material properties, performance standards (like resistance to permeation by chemotherapy drugs and fentanyl citrate), and biocompatibility.

Therefore, I cannot extract the requested information regarding AI/ML device acceptance criteria or related studies from this document. The questions about sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth, and training sets are not applicable to the type of device described in this FDA submission.

However, I can extract the acceptance criteria and performance data for the physical device as described:

1. Table of Acceptance Criteria and Reported Device Performance:

The primary performance criterion for the "Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue)" is its resistance to permeation by chemotherapy drugs and fentanyl citrate. The acceptance criterion is a minimum breakthrough detection time for each substance.

Additional Acceptance Criteria and Performance Data (already met by similar predicate device or physical properties):

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The Nitrile Powder Free Examination Gloves Biodegradable (Green) is a medical glove which is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between examiner and patient.

Nitrile Powder Free Examination Gloves Biodegradable (Green) meet all the requirements of ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application. The gloves are single use, disposable, and non-sterile. The gloves are offered in five sizes: S, M, L, XL, XXL.

The provided document is a 510(k) Premarket Notification for Nitrile Powder Free Examination Gloves Biodegradable (Green). It describes the device, its intended use, and comparative testing against a predicate device to demonstrate substantial equivalence.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Important Note: This document pertains to a medical device (examination gloves) that is a physical product, not an AI/software-based device. Therefore, several of the requested categories (e.g., number of experts for ground truth, MRMC study, training set ground truth) are not applicable in this context, as they relate specifically to the validation of AI/ML systems or diagnostic aids, not physical medical devices like gloves.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for these gloves are primarily based on established ASTM and ISO standards for medical examination gloves and biocompatibility.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the numerical sample size for each specific test (e.g., how many gloves were tested for dimensions, tensile strength, or holes). However, the tests are conducted according to recognized standards (ASTM, ISO), which inherently specify sampling plans and test methods (e.g., AQL 1.5 for hole detection typically implies a specific sampling size based on lot size).

• Data Provenance: The tests were conducted by the manufacturer, Comfort Rubber Gloves Industries Sdn. Bhd., located in Matang, Perak, Malaysia. The data appears to be prospective as it directly supports the 510(k) submission for this specific device.

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

Not Applicable. For a physical product like medical gloves, "ground truth" is established through standardized physical, chemical, and biological testing methods (e.g., measuring dimensions, tensile strength, or observing biological reactions in animal models), not through expert consensus on interpretations like with AI/imaging data. The standards themselves define the "ground truth" for compliance.

4. Adjudication Method for the Test Set

Not Applicable. Adjudication methods (e.g., 2+1, 3+1) are relevant for subjective human assessments, particularly in image interpretation or clinical diagnosis. For physical and chemical property testing of gloves, the results are typically objective measurements or observations by trained laboratory personnel following the specified test protocols.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Reader Improvement

Not Applicable. MRMC studies are used to evaluate the diagnostic performance of a system (often AI-assisted) by comparing human reader performance with and without the system. This is not relevant for a physical product like examination gloves.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done

Not Applicable. "Standalone" performance refers to the diagnostic capability of an algorithm or AI without human interaction. This concept does not apply to a physical medical device. The device's performance is intrinsically linked to its physical and material properties.

7. The Type of Ground Truth Used

The "ground truth" for this device is based on objective measurements and observations derived from:

• Standardized Test Methods: Adherence to established and recognized international standards (e.g., ASTM D6319-19, ASTM D5151-19, ASTM D5511-18, ASTM D6124-06(2022), ISO 10993 series). These standards define the test procedures and acceptance criteria for various physical, chemical, and biological properties.
• Direct Physical and Chemical Analysis: Measurements of dimensions, tensile strength, elongation, residual powder, and observations of biodegradation and biocompatibility reactions.
• Biological Endpoints: For biocompatibility, the ground truth is based on the observed biological response (e.g., presence/absence of irritation, sensitization, or systemic toxicity) in established animal or in-vitro models as per ISO 10993.

8. The Sample Size for the Training Set

Not Applicable. The concept of a "training set" (for machine learning models) does not apply to the development or validation of a physical medical device like these gloves. The manufacturing process is controlled by quality management systems (e.g., 21 CFR Part 820 Quality System Regulation), and product performance is validated through testing of manufactured lots against specifications, not through machine learning.

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

Not Applicable. As mentioned above, there is no "training set" in the context of this device. The physical and performance characteristics are inherent to the material and manufacturing process, validated through testing against pre-defined standards.

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The GenaCheck™ Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate is a specialty medical glove which is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between examiner and patient. The glove was tested for use with Chemotherapy Drugs and Fentanyl Citrate as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.

The subject device is single use, disposable gloves intended for medical purposes to be worn on the examiner's hands to prevent contamination between patient and examiner. The gloves are powderfree, ambidextrous with beaded cuff, purple colored, nitrile, and tested for use with chemotherapy drugs and Fentanyl Citrate. The gloves are offered in five sizes: XS, S, M, L, XL. The subject device is non-sterile.

Here's a breakdown of the acceptance criteria and study information for the GenaCheck™ Nitrile Powder Free Examination Glove, based on the provided FDA document:

1. Table of Acceptance Criteria and Reported Device Performance

Study Details:

For medical gloves, the "study" demonstrating that the device meets acceptance criteria typically refers to a series of non-clinical, laboratory bench tests conducted according to recognized consensus standards.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the specific sample sizes for each test. However, it references the standards used, which often specify sample sizes.

• For Watertightness Test (ASTM D5151-19), the result "0/125/Pass" indicates that 125 samples were tested, with 0 failures.
• For other tests like physical dimensions, powder content, and physical properties, the sample sizes are described by the respective ASTM standards but not explicitly listed in this summary.
• Data Provenance: The document does not specify the country of origin of the data. The tests are "non-clinical testing" (bench tests) rather than human subject studies, so there's no "retrospective or prospective" status in the same sense as clinical data.

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

This information is not applicable for this type of device and study. The "ground truth" for non-clinical performance and material properties standards is established by the specifications defined within the referenced ASTM and ISO standards themselves (e.g., a tensile strength of ≥14 MPa, or a specific AQL for holes). There are no human experts classifying outcomes in the way one would for diagnostic imaging.

4. Adjudication Method for the Test Set

This is not applicable. Adjudication methods like "2+1" are used for human-reviewed data sets (e.g., medical image interpretation consensus). For bench testing against pre-defined engineering and material specifications, the results are quantitative measurements compared directly to the acceptance criteria.

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 comparing the performance of diagnostic tools (e.g., AI algorithms for interpreting medical images) with and without human readers' involvement. The device here is a medical glove, for which MRMC studies are not applicable.

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

No, a standalone study in the context of an "algorithm only" performance was not done. This concept is specific to software medical devices or AI algorithms. The GenaCheck™ glove is a physical medical device.

7. The Type of Ground Truth Used

The "ground truth" for the performance tests relies on established industry and regulatory standards.

• For physical properties, it's defined quantities like minimum tensile strength (e.g., ≥14 MPa).
• For resistance to permeation by chemotherapy drugs, it's the measured "breakthrough detection time" according to the specified method (ASTM D6978-05).
• For biocompatibility, it's the absence of adverse biological reactions (non-irritating, non-sensitizing, no acute systemic toxicity, and comparison to predicate regarding cytotoxicity) as defined by ISO 10993 series.

8. The Sample Size for the Training Set

There is no training set for this device. Training sets are applicable to machine learning algorithms. The GenaCheck™ glove is a physical product, not an AI/ML algorithm.

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

This is not applicable as there is no training set.

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The Nitrile Powder Free Examination Gloves (Blue), Non-Sterile Low Dermatitis Potential is a medical glove which is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between examiner and patient.

Nitrile Powder Free Examination Gloves (Blue), Non-Sterile Low Dermatitis Potential meet ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application.

This document pertains to the 510(k) submission for Nitrile Powder Free Examination Gloves (Blue), Non-Sterile Low Dermatitis Potential (K241528).

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

2. Sample size used for the test set and the data provenance:

• Physical Dimensions, Physical Properties, Powder Residue, Freedom from Holes: The specific sample sizes are not explicitly stated within the provided text, but the tests were conducted according to ASTM and ISO standards (e.g., ISO 2859-1/S2/AQL 4.0 for dimensions, AQL 1.5 for freedom from holes), which prescribe sampling plans. The data provenance is from non-clinical tests conducted by the manufacturer, Comfort Rubber Gloves Industries Sdn. Bhd. No country of origin for the specific testing labs is provided, nor is it specified if the data is retrospective or prospective, though it's likely prospective for the submission.
• Irritation, Sensitization, Cytotoxicity, Acute systemic toxicity: The specific sample sizes for these biocompatibility tests are not explicitly stated in the document. These tests are likely performed ex vivo or in vivo with animal models (e.g., mice for acute systemic toxicity) or in vitro (e.g., for cytotoxicity). The data provenance is from non-clinical tests conducted by the manufacturer.
• Low Dermatitis Potential (Modified Draize): The specific sample size for the human repeat insult patch test (HRIPT) is not explicitly stated. The Modified Draize test (ASTM 6355-07) is a clinical test involving human subjects, therefore, the data provenance is clinical, likely from a prospective study.

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

This information is not provided in the document. The tests performed are primarily laboratory-based or standardized clinical tests with defined acceptance criteria, rather than requiring expert interpretation for ground truth establishment in the traditional sense of medical image analysis or complex diagnostic tasks. The "ground truth" for these tests is the quantitative or qualitative outcome against a standard.

4. Adjudication method for the test set:

Not applicable. The tests performed are objective, standardized tests with predefined acceptance criteria. There is no mention or implication of a need for adjudication by multiple human experts for the results of these physical, chemical, or biological tests.

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 device is a medical glove, not an AI-powered diagnostic or assistive technology. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is irrelevant to this submission.

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

Not applicable. This device is a medical glove, not an algorithm or software.

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

The ground truth for most of these tests is based on objective measurements and established standards:

• Physical Properties (Dimensions, Tensile Strength, Elongation, Powder Residue, Freedom from Holes): Ground truth is based on quantitative measurements against the physical requirements specified in ASTM D6319-19, ASTM D412-16(2021), ASTM D6124-06(2022), and ASTM D5151-19.
• Biocompatibility (Irritation, Sensitization, Acute Systemic Toxicity): Ground truth is based on observations and measurements from standardized biological evaluations (ISO 10993 series) against set criteria for biological responses.
• Cytotoxicity: Ground truth is based on observable cellular responses in in vitro tests (ISO 10993-5).
• Low Dermatitis Potential (Modified Draize): Ground truth is based on the absence of clinical evidence of Type IV allergy in human subjects, as observed and reported in the HRIPT study, following ASTM 6355-07. This involves clinical observation in human subjects.

8. The sample size for the training set:

Not applicable. This is a physical medical device (gloves) and not an AI/ML-based algorithm that requires a training set.

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

Not applicable. As this device is a medical glove, it does not involve a training set or associated ground truth establishment for an AI/ML model.

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Nephron Nitrile™, Nitrile Powder-Free Examination Gloves Black (Tested For Use With Chemotherapy Drugs and Fentanyl) is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.

In addition, these gloves were tested for use with Chemotherapy drugs and Fentanyl in accordance with ASTM D6978-05 (2019) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.

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

Bleomycin Sulfate (15.0 mg/ml) Busulfan (6.0 mg/ml) Carboplatin (10.0 mg/ml) Cisplatin (1.0 mg/ml) Cyclophosphamide (20.0 mg/ml) Cytarabine (100.0 mg/ml) Dacarbazine (10.0 mg/ml) Daunorubicin HCl (5.0 mg/ml) Docetaxel (10.0 mg/ml) Doxorubicin HCl (2.0 mg/ml) Epirubicin HCl (2.0 mg/ml) Etoposide (20.0 mg/ml) Fludarabine (25.0 mg/ml) Fluorouracil (50.0 mg/ml) Gemcitabine (38.0 mg/ml) Idarubicin HCl (1.0 mg/ml) Ifosfamide (50.0 mg/ml) Irinotecan (20.0 mg/ml) Mechlorethamine HCl (1.0 mg/ml) Melphalan (5.0 mg/ml) Methotrexate (25.0 mg/ml) Mitomycin C (0.5 mg/ml) Mitoxantrone HCl (2.0 mg/ml) Paclitaxel (6.0 mg/ml) Rituximab (10.0 mg/ml) Trisenox (1.0 mg/ml) Vincristine Sulfate (1.0 mg/ml)

The tested Opioid is: Fentanyl Citrate Injection (100 mcg/2 mL) Permeation: no breakthrough up to 240 minutes

The following chemotherapy drugs have low permeation times: Carmustine (3.3 mg/ml) : 26.3 minutes Thiotepa (10.0 mg/ml) : 49.1 minutes Warning: Not for Use with: Carmustine, Thiotepa

Nephron Nitrile™, Nitrile Powder-Free Examination Gloves Black (Tested For Use With Chemotherapy Drugs and Fentanyl) are Class I patient examination gloves, bearing the product codes LZA, LZC, OPJ, QDO (21 CFR 880.6250). They meet all the current specifications listed under the ASTM D6319-19, Standard Specification for Nitrile Examination Gloves for Medical Application and also complies with requirements for Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs as per ASTM D6978-05 (2019). The powder-free gloves are made from Nitrile (NBR) latex and are black in color. The product is non-sterile, fingertip textured, ambidextrous with beaded cuff, and single use only.

Nephron Nitrile™, Nitrile Powder-Free Examination Gloves Black (Tested For Use With Chemotherapy Drugs and Fentanyl) include glove sizes: X-Small, Medium, Large, X-Large and XX-Large.

The provided text describes the acceptance criteria and the results of a study for the "Nephron Nitrile™, Nitrile Powder-Free Examination Gloves Black (Tested For Use With Chemotherapy Drugs and Fentanyl)".

Here's a breakdown of the requested information:

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

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

The document lists "Bench Data" and "Biocompatibility Data" for the non-clinical tests. For these types of tests, specific sample sizes beyond what's typically required by the ASTM or ISO standards are not detailed in this summary. The data provenance is not specified, but these are standard laboratory tests. It is implied these are prospective tests conducted on the subject device.

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 section is Not Applicable (N/A). The device is a medical glove, and the evaluation relies on established standardized physical, chemical permeation, and biocompatibility tests, not subjective expert assessment of images or clinical outcomes that would require ground truth establishment by human experts.

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

This section is Not Applicable (N/A). Adjudication methods like 2+1 or 3+1 are used for resolving disagreements in expert assessments (e.g., in medical image interpretation). The tests performed are objective, standardized laboratory tests.

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 section is Not Applicable (N/A). This device is a medical glove, not an AI-assisted diagnostic tool. Therefore, MRMC studies and AI assistance are irrelevant.

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

This section is Not Applicable (N/A). This device is a medical glove, not an algorithm.

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

The "ground truth" for the performance of the gloves is established by objective measurements against the specified ASTM and ISO standards. For instance:

• Physical properties (length, width, thickness, tensile strength, elongation) are measured directly.
• Freedom from holes is determined by leakage tests per ASTM D5151-19.
• Powder residue is measured per ASTM D6124-06.
• Resistance to permeation by chemotherapy and opioid drugs is determined by measuring breakthrough time according to ASTM D6978-05.
• Biocompatibility is assessed through standardized biological tests (irritation, sensitization, systemic toxicity) as per ISO 10993 series.

8. The sample size for the training set

This section is Not Applicable (N/A). The device is a physical product (medical glove) and does not involve machine learning models that require training sets.

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

This section is Not Applicable (N/A), as it refers to a training set for machine learning, which is irrelevant for this medical device.

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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.

These gloves were tested for use with Chemotherapy Drugs and Fentanyl Citrate as per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.

Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Black), Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Orange) are made from synthetic rubber latex. It is single use and powder-free. The subject device is a patient examination glove made from nitrile latex compound, Black and Orange color, powder free and non-sterile (Per 21 CFR 880.6250, class I). The device meets all the specifications in ASTM D6319-19, Standard specification for Nitrile Examination Gloves. The available sizes are Small, Medium, Large ,X-Large and XX-Large.

Here's a breakdown of the acceptance criteria and the study information based on the provided text, formatted as requested:

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

The provided document lists various performance criteria for the Nitrile Powder Free Examination Gloves (Black and Orange) and reports the results against these criteria.

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

• Sample Size for Physical/Dimensional/Chemical Tests: For "Freedom From Holes," the sampling size is stated as 125 pieces (Ac: 7, Re: 8). The specific sample size for other physical/dimensional tests (length, width, thickness, tensile strength, elongation, residual powder content) is not explicitly stated, but the tests are reported as meeting ASTM D6319-19 and ASTM D6124-06 requirements. For Biocompatibility tests, no specific sample size is given, but the studies involve guinea pigs and rats, implying animal testing was conducted.
• Sample Size for Chemotherapy Drug Permeation Tests: Not explicitly stated within the document. The tests are reported as per ASTM D6978-05 (Reapproved 2019).
• Data Provenance: The manufacturing company is Dehai (Shandong) Medical Gloves, Co., Ltd. located in Zibo City, Shandong Province, China. The testing would presumably have been conducted in a laboratory, potentially in China or a third-party testing facility. The document doesn't specify if the data is retrospective or prospective, but testing of device performance characteristics is generally prospective for regulatory submissions.

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

Not applicable. This device is a medical glove, and its performance is evaluated against established physical, chemical, and biological standards (ASTM, ISO). There is no "ground truth" established by human experts in the way an AI diagnostic algorithm would require. The "ground truth" is defined by the objective metrics and thresholds specified in the referenced ASTM and ISO standards.

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

Not applicable. Adjudication methods like 2+1 or 3+1 are used for establishing consensus ground truth in studies involving human interpretation (e.g., radiology reads). This document pertains to physical and chemical testing of a medical device against predefined standards, which does not involve such 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. This document is for a medical glove, not an AI-assisted diagnostic device. Therefore, no MRMC study or AI assistance evaluation was performed.

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

Not applicable. This device is a medical glove, not an algorithm or AI system.

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

The "ground truth" for this device's performance is based on established industry standards and objective material properties. Specifically:

• ASTM D6319-19: Standard specification for Nitrile Examination Gloves.
• ASTM D5151-19: Standard test methods for detection of holes in medical gloves.
• ASTM D6124-06: Standard test method for residual powder on medical gloves.
• ASTM D6978-05 (Reapproved 2019): Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
• ISO 10993-23, ISO 10993-10, ISO 10993-11: Biocompatibility standards for medical devices (Primary Skin Irritation, Skin Sensitization, Acute Systemic Toxicity).

These standards define the acceptable range or threshold for each characteristic (e.g., minimum tensile strength, maximum powder residue, minimum breakthrough time for drugs).

8. The sample size for the training set

Not applicable. This device is a medical glove, not a machine learning model, so there is no training set.

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

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

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