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This device is an ambidextrous patient examination glove that is a non-sterile, single use, disposable device intended for medical purposes, worn on the examiner's hand or finger to prevent contamination between patient and examiner. The tested chemotherapy drugs are: Carmustine (BCNU) (3.3 mg/ml). Permeation time: Carmustine (BCNU) has extremely low permeation times of 14.7 minutes. Cisplatin (1.0 mg/ml). Permeation time: no breakthrough up to 240 minutes Cyclophosphamide (Cytoxan) (20.0 mg/ml). Permeation time: no breakthrough up to 240 minutes Cytarabine (100 mg/ml). Permeation time: no breakthrough up to 240 minutes Dacarbazine (DTIC) (10.0 mg/ml). Permeation time: no breakthrough up to 240 minutes Doxorubicin Hydrochloride (2.0 mg/ml). Permeation time: no breakthrough up to 240 minutes Etoposide (20.0 mg/ml). Permeation time: no breakthrough up to 240 minutes Fluorouracil (50.0 mg/ml). Permeation time: no breakthrough up to 240 minutes lfosfamide (50.0 mg/ml). Permeation time: no breakthrough up to 240 minutes Methotrexate (25.0 mg/ml). Permeation time: no breakthrough up to 240 minutes Mitomycin C (0.5 mg/ml). Permeation time: no breakthrough up to 240 minutes Mitoxantrone (2.0 mg/ml). Permeation time: no breakthrough up to 240 minutes Paclitaxel (Taxol) (6.0 mg/ml). Permeation time: no breakthrough up to 240 minutes Thiotepa (10.0 mg/ml). Permeation time: Thiotepa has extremely low permeation times of 13.6 minutes Vincristine Sulfate (1.0 mg/ml). Permeation time: no breakthrough up to 240 minutes The tested Opioid is: Fentanyl Citrate Injection (100mcg/2mL). Permeation: no breakthrough up to 240 minutes Please note that the following drugs have extremely low permeation times: Carmustine: 14.7 minutes Thiotepa: 13.6 minutes Warning: DO NOT USE WITH CARMUSTINE OR THIOTEPA

The Non-Sterile, Single use, Powder-free Examination glove, Blue, tested for use with Chemotherapy Drugs and fentanyl is provided in blue. It meets all the requirements of ASTM D6319. It is a 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. In addition, these gloves were tested for use with chemotherapy drugs as well as Fentanyl, per ASTM D6978 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drug. It can be available in 4 specifications: S, M, L and XL.

The provided text is a 510(k) summary for a Nitrile Examination Glove. It details the device's characteristics, indications for use, and non-clinical testing conducted to support its substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and the study performed, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not explicitly state the sample sizes used for each specific test in the test set. However, it indicates tests were conducted according to ASTM and ISO standards, which typically specify sampling plans. The data provenance is not mentioned, so we cannot determine the country of origin of the data or whether it was retrospective or prospective.

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

This information is typically not applicable to studies for medical gloves, as the "ground truth" is established by direct physical, chemical, and biological testing against predefined scientific standards, not by expert consensus or review of diagnostic images.

4. Adjudication Method for the Test Set:

Not applicable, as the tests involve objective measurements against established standards, not interpretation by experts 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 is a medical glove, not an AI-powered diagnostic or assistive device.

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

Not applicable. This is a medical glove, not an algorithm. The device performance is assessed through laboratory testing.

7. The Type of Ground Truth Used:

The ground truth for the device's performance is based on objective measurements and chemical/physical assessments against established industry standards (ASTM and ISO). For example:

• Dimensional measurements: Direct physical measurement.
• Physical properties (Tensile strength, Elongation): Mechanical testing.
• Freedom from holes: Water leak test as per ASTM D5151.
• Powder-free residue: Gravimetric analysis as per ASTM D6124.
• Biocompatibility (Irritation and Sensitization): Biological testing on animal models (typically as per ISO 10993-10).
• Permeation by Fentanyl and Chemotherapy Drugs: Chemical permeation testing as per ASTM D6978, measuring breakthrough time.

8. The Sample Size for the Training Set:

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

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This device is an ambidextrous patient examination glove that is non-sterile, single use, disposable device intended for medical purposes, worn on the examiner's hand to prevent contamination between patient and examiner. The glove was tested for use with Chemotherapy Drugs as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs listed below

Do not use with Carmustine and Thiotepa.

Please note that the following drugs have extremely low permeation times: Carmustine (BCNU): 15.9 minutes and Thiotepa:11.1 minutes.

The Powder-free Nitrile Patient Examination Glove, Green Colored, Non-sterile, Low Dermatitis Potential, and Tested for Use with Chemotherapy Drugs meets all the requirements of ASTM standard D6319-10. It is an ambidextrous medical glove, which is a disposable device, provided in x-small, medium, large and xlarge sizes. In addition, these gloves were tested for use with chemotherapy drugs per ASTM D6978-05 "Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drug," and Modified-Draize-95 Test, per FDA guidance document "Guidance for Industry and FDA Reviewers/Staff: Premarket Notification [510(k)] Submissions for Testing for Skin Sensitization to Chemicals in Natural Rubber Products," 1999.

The provided text describes the acceptance criteria and performance of a medical device, specifically a "Powder-free Nitrile Patient Examination Glove." This document is a 510(k) summary submitted to the FDA, demonstrating substantial equivalence to a predicate device.

It's important to note that this document does not describe an AI/ML medical device. The "device" in question is a physical glove, and the "tests" are for its physical properties and chemical resistance, not for an algorithm's performance on a dataset. Therefore, many of the requested fields related to AI/ML device testing (e.g., sample size for training set, number of experts for ground truth, MRMC study, standalone algorithm performance) are not applicable to this document.

However, I can extract the relevant information regarding the acceptance criteria and how the glove's performance was proven based on the provided text.

Acceptance Criteria and Device Performance (for a physical medical glove)

The document primarily focuses on demonstrating that the subject device (the green nitrile glove) is substantially equivalent to a predicate device (blue or white nitrile gloves) by meeting established standards for patient examination gloves and resistance to chemotherapy drugs.

1. Table of Acceptance Criteria and Reported Device Performance

Chemotherapy Drug Permeation Specifics (from "Indications for Use" and "Technological Characteristics" tables):

Important Note: The document explicitly states "Do not use with Carmustine and Thiotepa" due to their extremely low permeation times, even though the subject device still improved upon Carmustine's breakthrough time compared to the predicate.

Regarding the AI/ML-specific questions (which are not applicable to this physical glove device):

2. Sample sizes used for the test set and the data provenance: Not applicable. Testing was on physical glove samples from various production lots, not on a dataset in the AI/ML context. Data provenance is implied to be from the manufacturer's testing of their product.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for physical properties (e.g., hole in glove, chemical permeation) is established through standardized laboratory tests, not human expert consensus. "Experts" would be laboratory technicians or chemists.
4. Adjudication method for the test set: Not applicable. Laboratory tests follow predefined protocols; no human adjudication is mentioned or implied for test results.
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 physical device, not an AI/ML algorithm.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical device.
7. The type of ground truth used: For physical and chemical tests, the ground truth is objective measurement against established ASTM (American Society for Testing and Materials) and ISO (International Organization for Standardization) standards. For biocompatibility, it's the biological response in standardized in-vitro or in-vivo (human repeat insult patch testing) models.
8. The sample size for the training set: Not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established: Not applicable.

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This device is an ambidextrous patient examination glove that is a non-sterile, single use, disposable device intended for medical purposes, worn on the examiner's hand or finger to prevent contamination between patient and examiner. The tested chemotherapy drugs are:

Carmustine (BCNU) (3.3 mg/ml). Permeation time: Carmustine (BCNU) has extremely low permeation times of 14.7 minutes.

Cisplatin (1.0 mg/ml). Permeation time: no breakthrough up to 240 minutes
Cyclophosphamide (Cytoxan) (20.0 mg/ml). Permeation time: no breakthrough up to 240 minutes
Cytarabine (100 mg/ml). Permeation time: no breakthrough up to 240 minutes
Dacarbazine (DTIC) (10.0 mg/ml). Permeation time: no breakthrough up to 240 minutes
Doxorubicin Hydrochloride (2.0 mg/ml). Permeation time: no breakthrough up to 240 minutes
Etoposide (20.0 mg/ml). Permeation time: no breakthrough up to 240 minutes
Fluorouracil (50.0 mg/ml). Permeation time: no breakthrough up to 240 minutes
Ifosfamide (50.0 mg/ml). Permeation time: no breakthrough up to 240 minutes
Methotrexate (25.0 mg/ml). Permeation time: no breakthrough up to 240 minutes
Mitomycin C (0.5 mg/ml). Permeation time: no breakthrough up to 240 minutes
Mitoxantrone (2.0 mg/ml). Permeation time: no breakthrough up to 240 minutes
Paclitaxel (Taxol) (6.0 mg/ml). Permeation time: no breakthrough up to 240 minutes
Thiotepa (10.0 mg/ml). Permeation time: Thiotepa has extremely low permeation times of 13.6 minutes
Vincristine Sulfate (1.0 mg/ml). Permeation time: no Breakthrough up to 240 minutes

DO NOT USE WITH CARMUSTINE OR THIOTEPA

The Non-Sterile, Single use, Powder-free Examination glove, Blue, tested for use with Chemotherapy Drugs is provided in blue. It meets all the requirements of ASTM D6319-10. It is a 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. In addition, these gloves were tested for use with chemotherapy drugs per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drug.

This document is a 510(k) premarket notification for a medical device, specifically non-sterile examination gloves tested for use with chemotherapy drugs. It is a declaration of substantial equivalence to a predicate device and therefore does not include a study to "prove the device meets acceptance criteria" in the way a clinical trial or algorithm validation study would. Instead, it presents information to demonstrate that the new device shares similar characteristics and performs comparably to a device already legally marketed.

Here's an analysis based on the information provided, framed to address your request for acceptance criteria and study details where applicable:

1. Table of Acceptance Criteria and Reported Device Performance

It's important to note that for this type of device (patient examination gloves), "acceptance criteria" primarily relate to compliance with established industry standards for glove properties and permeation resistance. The document doesn't explicitly state numerical acceptance criteria for all aspects in a centralized table, but rather implies compliance with ASTM standards and compares performance to a predicate device.

However, we can extract the key performance metrics and their "acceptance" (or rather, "demonstrated") values, particularly for chemotherapy drug permeation resistance.

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

This document describes a medical device, which is a physical product (gloves). The "test set" in this context refers to the samples of gloves subjected to various physical and chemical tests, not a dataset for an AI algorithm.

• Sample Size: Not explicitly stated as a single number. However, the use of standards like ASTM D6319-10, ASTM D6978-05, ASTM D5151-06, ISO 2859-1 (for sampling procedures), ASTM D412-16, ASTM D3767-03, and ASTM D573-04 implies that samples were chosen and tested in accordance with the methodologies prescribed by these standards, which define specific sample sizes for their respective tests (e.g., number of gloves for permeation, tensile strength, barrier integrity, etc.).
• Data Provenance: The document states the device is manufactured by "SEMPERIT INVESTMENTS ASIA PTE. LTD." located in Singapore and mentions "Made in Malaysia" on the labeling. The testing was conducted to international (ISO) and U.S. (ASTM) standards. This indicates the testing was likely conducted in an approved laboratory, possibly in Malaysia or another location accredited to perform these tests to the specified standards. The data is prospective in the sense that the new device was specifically manufactured and tested to demonstrate its properties.

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

This question is not applicable to this type of device submission. There isn't "ground truth" established by human experts in the context of diagnostic imaging or clinical assessment. The "truth" here is determined by objective, measurable physical and chemical properties as defined by the ASTM and ISO standards for examination gloves and their resistance to chemicals.

4. Adjudication Method for the Test Set

Not applicable. Physical and chemical tests typically follow predefined protocols. The results are quantitative measurements or qualitative observations reported by the testing laboratory, not subject to human adjudication in the way medical diagnoses are.

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/software device. There are no "human readers" to compare performance with or without AI assistance.

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

Not applicable. This is not an algorithm or AI device.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for this device relies on:

• Defined Standards: Compliance with physical, mechanical, and chemical resistance properties as outlined in the referenced ASTM and ISO standards (e.g., ASTM D6319-10 for general glove properties, ASTM D6978-05 for chemotherapy drug permeation).
• Objective Measurement: Permeation times for chemotherapy drugs are determined through laboratory testing using established scientific methods, typically involving detection of the drug on the "inside" surface of the glove material after a certain exposure time. Similar objective measurements are used for tensile strength, barrier integrity, dimensions, etc.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device 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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The Sterile Powder Free Synthetic Rubber Gloves is a single use disposable device intended to be worn by operating room personnel to protect a surgical wound from contamination.

Sempermed Syntegra IR is a sterile powder-free surgeon glove. It is a disposable device made of synthetic polyisoprene rubber inside coated with synthetic material to ease donning the glove. This glove is intended to be worn on hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants.

The document describes the acceptance criteria and performance of the "Sempermed Syntegra IR, Sterile Powder Free Synthetic Rubber Surgeons Gloves." The device is a surgical glove, and its performance is evaluated against ASTM standards and ISO standards for biocompatibility.

Here's a breakdown of your requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

Detailed Study Information:

The provided document is a 510(k) Premarket Notification summary for a medical device (surgical gloves). It focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than a clinical study proving device effectiveness in a diagnostic or treatment context. Therefore, many of the questions regarding clinical study design (sample size for test/training sets, experts, MRMC, etc.) are not applicable to this type of submission.

Here's what can be inferred from the document:

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

• Not Applicable in the traditional sense of a diagnostic/AI test set. The "test set" here refers to samples of the manufactured gloves used for physical and biocompatibility testing. The document does not specify the sample sizes for these tests, but they would be governed by the respective ASTM and ISO standard methodologies (e.g., AQL for watertight testing).
• Data Provenance: Not specified, but the manufacturing company is Semperit Investment Asia Pte. Ltd. (Singapore), and the standards applied are international (ASTM, ISO). The tests would likely be conducted by the manufacturer or a certified testing laboratory.

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)

• Not Applicable. For physical and biocompatibility testing of surgical gloves, "ground truth" is established by adherence to standardized measurement and analytical protocols defined by ASTM and ISO organizations, not by expert consensus in the diagnostic sense.

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

• Not Applicable. Adjudication methods are typically for subjective assessments or when there's disagreement among human readers/experts. These tests involve objective measurements and chemical/biological assays.

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 physical device (surgical glove), not an AI diagnostic tool.

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

• Not Applicable. This is a physical device (surgical glove), not an algorithm.

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

• The "ground truth" for the performance claims about the surgical glove is established by adherence to objective, standardized measurements and biological assays as defined by the referenced ASTM and ISO standards (e.g., tensile strength, elongation, powder content, skin irritation, sensitization, watertightness).

8. The sample size for the training set

• Not Applicable. This is not an AI/machine learning device that requires a training set.

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

• Not Applicable. As above, no training set for an AI model.

In summary: The document demonstrates that the "Sempermed Syntegra IR, Sterile Powder Free Synthetic Rubber Surgeons Gloves" meets established performance standards for surgical gloves, primarily by demonstrating its physical characteristics and biocompatibility conform to ASTM and ISO specifications. The evaluation is focused on non-clinical performance data to show substantial equivalence to a legally marketed predicate device, rather than a clinical comparative study or an AI algorithm validation.

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