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A powder-free sterile surgeon's glove is a disposable device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs:

| | Chemotherapy Drug and Concentration | Minimum Breakthrough Detection Time,
0.01 µg/cm²/minute |
|-----|-------------------------------------|------------------------------------------------------------|
| 1. | Carmustine (BCNU) (3.3 mg/ml) | 17.9 |
| 2. | Cisplastin, (1.0 mg/ml) | >240 |
| 3. | Cyclophosphamide (20 mg/ml) | >240 |
| 4. | Doxorubicin HCl (2.0 mg/ml) | >240 |
| 5. | Etoposide (Toposar) (20 mg/ml) | >240 |
| 6. | Fluorouracil (50 mg/ml) | >240 |
| 7. | Methotrexate (25 mg/ml) | >240 |
| 8. | Paclitaxel (Taxol) (6.0 mg/ml) | >240 |
| 9. | Thiotepa (10 mg/ml) | 40.3 |
| 10. | Vincristine Sulfate (1.0 mg/ml) | >240 |

WARNING: Do not use with Carmustine (BCNU) (3.3 mg/m1)

CAUTION: Testing showed an average breakthrough time of 40.3 minutes with Thiotepa (10 mg/ml).

The proposed device is a disposable device. It is not made with natural rubber latex. Instead, the gloves are formulated using polyisoprene and neoprene, which are synthetic rubber latex. The gloves are manufactured using molds that feature anti-slip finish, independent thumb and mechanically locking cuffs to help prevent cuff roll down. They are offered powder-free and sterile. This glove is for single use only.

Please find the requested information regarding the acceptance criteria and study details below.

1. Table of acceptance criteria and the reported device performance:

• Cisplatin (1.0 mg/ml): >240 minutes
• Cyclophosphamide (20 mg/ml): >240 minutes
• Doxorubicin HCl (2.0 mg/ml): >240 minutes
• Etoposide (Toposar) (20 mg/ml): >240 minutes
• Fluorouracil (50 mg/ml): >240 minutes
• Methotrexate (25 mg/ml): >240 minutes
• Paclitaxel (Taxol) (6.0 mg/ml): >240 minutes
• Thiotepa (10 mg/ml): 40.3 minutes (CAUTION: Testing showed an average breakthrough time of 40.3 minutes)
• Vincristine Sulfate (1.0 mg/ml): >240 minutes |
  | Powder Residual | ASTM D3577 (≤2.0 mg/glove) | Meets requirements (≤2.0 mg/glove for Powder-Free designation) |

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

• Sample Size for Test Set: The document does not explicitly state the sample size for each specific test (e.g., how many gloves were tested for permeation, how many samples for biocompatibility). However, it indicates compliance with standards like ASTM D3577 and ASTM D6978, which would inherently dictate minimum sample sizes for their respective tests.
• Data Provenance: Not explicitly stated (e.g., country of origin, retrospective or prospective). The tests are reported as "conducted for determination of substantial equivalence."

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 surgical glove, and the "ground truth" for its performance is established through standardized laboratory tests (e.g., chemical permeation, physical properties) as per ASTM and ISO standards, not through expert consensus on interpretation of medical images or clinical outcomes.

4. Adjudication method for the test set:

• Not applicable. As noted above, performance is determined by objective laboratory measurements against established standards, not through adjudication of expert opinions.

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 a medical device (surgical glove), not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC comparative effectiveness study involving human readers and AI is irrelevant.

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

• Not applicable. This is a physical medical device (surgical glove), not an algorithm or AI system.

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

• The "ground truth" for the device's performance is based on objective measurements and results from standardized laboratory tests according to recognized industry standards (e.g., ASTM D6978 for chemotherapy drug permeation, ASTM D3577 for physical properties, ISO 10993 for biocompatibility).

8. The sample size for the training set:

• Not applicable. This is a physical medical device, not an AI model that requires a "training set."

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

• Not applicable. As above, no training set is relevant for this 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.

The proposed device is a disposable device intended for over the counter use. It is not made with natural rubber latex. Instead, the gloves are formulated using vinyl synthetic polymer. The glove is coated with an emollient coating. The gloves are manufactured using molds that are ambidextrous. They are offered powder-free and non-sterile.

The provided document describes the acceptance criteria and performance data for the Cardinal Health™ Vinyl Powder-Free Exam Gloves with Neu-Thera® Coating. This is a medical device application for examination gloves, and therefore the "device" in this context refers to these gloves.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and the Reported Device Performance

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A powder-free sterile surgeon's glove is a disposable device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.

The proposed device is a disposable device. It is not made with natural rubber latex. Instead, the gloves are formulated using polyisoprene, which is a synthetic rubber latex, and is brown in color. The glove is coated with hydrogel polymer coating.

The gloves are manufactured using molds that feature anti-slip finish, independent thumb and mechanically locking cuffs to help prevent cuff roll down. They are offered powder-free and sterile. This glove is for single use only.

This glove is suitable for use as a specialty surgical glove intended for orthopedic procedures or other procedures where a thicker barrier may be desired such as trauma and reconstructive surgery

The document describes the acceptance criteria and study for the Cardinal Health™ Sterile Polyisoprene Powder-Free Orthopedic Surgical Gloves with Hydrogel Coating. This is a medical device, and the study focuses on its physical and biological performance against established standards rather than artificial intelligence or diagnostic capabilities. Therefore, some of the requested information regarding AI-specific elements (like human reader improvement with AI, ground truth for training sets, etc.) is not applicable.

Here's the information extracted from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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A powder-free sterile surgeon's glove is a disposable device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.

The proposed device is a disposable device. It is not made with natural rubber latex. Instead, the gloves are formulated using neoprene synthetic polymer and are coated with nitrile coating and is yellow in color.

The glove are manufactured using molds that feature anti-slip finish, independent thumb and mechanically locking cuffs to help prevent cuff roll down. They are offered powder-free and sterile. This glove is for single use only.

The provided document describes the acceptance criteria and the study for "Cardinal Health™ Sterile Neoprene Powder-free Surgical Gloves with Nitrile Coating and Tested for Use with Chemotherapy Drugs (Yellow)." This is a medical device, specifically a surgical glove, and the study focuses on its physical properties, biocompatibility, and resistance to chemotherapy drug permeation. There is no AI component mentioned in this documentation, therefore, several of the requested categories (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set sample size, ground truth for training) are not applicable.

Here's the breakdown of the information that can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

The device is evaluated against various standards, primarily ASTM D3577 for surgical gloves and ASTM D6978 for chemotherapy drug permeation.

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A powder-free 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.

The proposed device is a disposable device intended for over the counter use and is provided powder-free and non-sterile. These patient examination gloves are formulated using Nitrile. Gloves are not made with natural rubber latex. The glove color is cool blue.

This device submission (K122696) is for Powder-Free Nitrile Examination Gloves (Cool Blue). It is a medical device designed to prevent contamination between patients and examiners. The submission focuses on demonstrating substantial equivalence to a predicate device by meeting established performance standards for patient examination gloves.

Here's an analysis of the acceptance criteria and the study that proves the device meets those criteria:

1. Table of Acceptance Criteria and Reported Device Performance:

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A powder-free sterile surgeon's glove is a disposable device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.

The proposed device is a disposable device intended for over the counter use and is provided powder-free and sterile. The glove is made with natural rubber latex and is cream in color. The glove is manufactured using molds that feature independent thumb and tapered mechanically locking cuffs to help reduce cuff roll down.

Here's a summary of the acceptance criteria and study information for the Protexis™ Latex Basic, Sterile Latex Powder-Free Surgical Gloves (Cream), based on the provided text:

Acceptance Criteria and Device Performance

The device is a modified version of an already cleared predicate device (K120934). The primary modification is the removal of colorant from the glove formulation. The acceptance criteria and performance are based on meeting established industry standards for surgical gloves and demonstrating substantial equivalence to the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

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A powder-free sterile surgeon's glove is a disposable device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.

The proposed device is a disposable device intended for over the counter use and is provided powder-free and sterile. It is made with natural rubber latex and is tan in color. The glove is manufactured using molds that feature independent thumb and tapered mechanically locking cuffs to help reduce cuff roll down.

The provided text describes the acceptance criteria and performance of the Protexis™ Latex Basic, Sterile Latex Powder-Free Surgical Gloves. No study proving the device meets the acceptance criteria is detailed in the submission; rather, the document declares that the device meets existing standards and requirements.

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

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify the exact sample sizes used for each test (e.g., for physical properties, protein content, or biocompatibility). It states that testing was performed according to specific ASTM and ISO standards, which would imply certain sample size requirements within those standards. However, the specific numbers are not reported.

The data provenance is not explicitly stated in terms of country of origin, nor is it explicitly labeled as retrospective or prospective. It is implied to be data collected as part of the device's development and testing for this premarket notification.

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

This information is not applicable to the device described. The device is a surgical glove, and its performance is evaluated against established physical, chemical, and biological standards (ASTM, ISO, CFR) rather than against expert-established ground truth in a diagnostic or interpretive sense. The "ground truth" here is the adherence to these published standards.

4. Adjudication Method for the Test Set

Adjudication methods like 2+1 or 3+1 are typically used in studies where human interpretation or assessment is involved (e.g., medical image reading). Since this submission concerns a physical medical device (surgical gloves) and its compliance with technical standards, such adjudication methods are not relevant or described. The tests are objective measurements against defined criteria.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was done. This type of study is relevant for diagnostic or interpretive devices where human readers are involved. For surgical gloves, the evaluation focuses on meeting predefined physical and biochemical standards.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. The device is a physical product, not an algorithm, so a standalone study in this context is irrelevant.

7. Type of Ground Truth Used

The "ground truth" used is defined by adherence to established industry and regulatory standards. Specifically:

• ASTM D3577 (for dimensions, physical properties, freedom from holes, powder residual)
• 21 CFR 800.20 (for AQL in freedom from holes)
• ASTM D6124 (for testing powder residual)
• ASTM D5712 (for protein content)
• FDA Medical Glove Guidance Manual (for protein content)
• ISO 10993-1 (for biocompatibility)
• ISO 10993-10 (for primary skin irritation and guinea pig maximization)

8. Sample Size for the Training Set

Not applicable. This device is a physical medical product, not an AI/ML algorithm that requires a training set.

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

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

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This powder-free surgeon's glove is a disposable device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.

The proposed device is a disposable device intended for over the counter use and is provided powder-free sterile. It is made with natural rubber latex. The glove is coated with nitrile coating. The glove is manufactured using exact same material used in the currently cleared device, Protegrity Blue glove (K053272). The glove is coated with emollient coating (containing Glycerol. Gluconolactone, D-Sorbitol and Provitamin-B). The glove is manufactured using molds that feature anti-slip finish, independent thumb, and tapered mechanically locking cuffs to help reduce cuff roll down.

The provided text describes the acceptance criteria and performance of Cardinal Health Protexis™ Latex Powder-Free Blue Surgical Gloves with Neu-Thera® Coating. It is a 510(k) submission, meaning the device is seeking substantial equivalence to a legally marketed predicate device, not necessarily proving revolutionary new efficacy.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

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This powder-free surgeon's glove is a disposable device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM m and the most go res world of Medical Gloves to Permeation by Chemotherapy Drugs.

The proposed device is a disposable device. It is not made with natural rubber latex. Instead, it is formulated from polyisoprene, which is a synthetic rubber latex. This Sterile Polyisoprene Powder-Free Surgical Glove is manufactured using exact same material used in the currently cleared device, Esteem SMT glove (K093300) that has been legally marketed by Cardinal Health. The glove is manufactured using molds that feature anti-slip finish, independent thumb, and tapered mechanically locking cuffs to help reduce cuff roll down. It is offered powder-free and sterile.

The provided document describes the safety and effectiveness summary for "Sterile Polyisoprene Powder-Free Surgical Gloves Tested for Use with Chemotherapy Drugs." This is for a medical device and not an AI or software device, therefore, the requested information elements related to AI/algorithm performance studies like sample size for test/training sets, data provenance, number/qualification of experts for ground truth, adjudication methods, MRMC studies, or standalone algorithm performance are not applicable.

The acceptance criteria and the study proving the device meets these criteria are related to the physical, chemical, and biological properties of the surgical gloves.

1. A 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 sample sizes for each specific test (e.g., how many gloves were tested for holes, or how many samples for biocompatibility). However, the tests were conducted according to recognized international and national standards (e.g., ISO 10993, ASTM D3577, ASTM D6978, 21 CFR 800.20), which typically specify appropriate sample sizes and methodologies.

The "data provenance" for this type of device (surgical gloves) would relate to the manufacturing and testing environment, not patient data. The tests are non-clinical, laboratory-based studies.

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

Not applicable. For surgical glove testing, "ground truth" is established by adherence to standardized test methods and criteria defined by organizations like ASTM and ISO, not by expert human consensus on medical images or diagnoses.

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

Not applicable. Adjudication methods are relevant for subjective assessments, typically in clinical studies or for AI output evaluation. The tests performed for these gloves (e.g., physical properties, chemical permeation) are objective laboratory measurements, not 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. This device is a physical medical glove, not an AI or imaging diagnostic tool.

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

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

7. The type of ground truth used

The "ground truth" for this device's performance is established by objective laboratory measurements and adherence to predefined specifications and test standards. For example:

• Biocompatibility: Determined by standardized in-vivo (e.g., guinea pig maximization) and in-vitro tests following ISO 10993.
• Physical Properties: Measured against specifications in ASTM D3577.
• Freedom from Holes: Determined by testing according to ASTM D5151 and meeting AQL (Acceptable Quality Level) requirements specified in 21 CFR 800.20 & ASTM D3577.
• Powder Residual: Measured using ASTM D6124 to meet ASTM D3577 limits.
• Chemotherapy Drug Permeation: Measured as breakthrough time using ASTM D6978.

8. The sample size for the training set

Not applicable. This is a physical device, not an AI model requiring a training set.

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

Not applicable. This is a physical device, not an AI model.

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A powder-free sterile surgeon's glove is a disposable device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.

The proposed device is a sterile latex powder-free surgical glove that is formulated using natural rubber latex. The glove is coated with hydrogel polymer coating. The glove is manufactured using molds that feature anti-slip finish, independent thumb and mechanically locking cuffs to help prevent cuff roll down. They are offered powder-free and sterile.

The provided document describes a 510(k) premarket notification for "Sterile Latex Powder-Free Surgical Gloves with Hydrogel Coating." This is a medical device, and the evaluation focuses on demonstrating substantial equivalence to a predicate device, rather than proving efficacy or a new clinical benefit through extensive clinical studies. Therefore, many of the typical elements of AI/software device studies (like MRMC studies, training set details, or complex ground truth establishment) are not applicable here.

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

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are based on compliance with ASTM standards and regulatory requirements for surgical gloves. The "reported device performance" refers to the results of tests conducted to demonstrate this compliance.

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