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

The tested chemotherapy drugs and permeation times are as follows:

Bleomycin Sulfate 15 mg/mL, >240 minutes
Busulfan 6 mg/mL, >240 minutes
Carboplatin (Paraplatin) 10 mg/mL, >240 minutes
Carmustine (BCNU) 3.3 mg/mL, 1.9 minutes
Cisplatin 1.0 mg/mL, >240 minutes
Cyclophosphamide (Cytoxan) 20 mg/mL, >240 minutes
Cytarabine HC1 100 mg/mL, >240 minutes
Dacarbazine (DTIC) 10 mg/mL, >240 minutes
Daunorubicin HC1 5 mg/mL, >240 minutes
Docetaxel 20 mg/mL, >240 minutes
Doxorubicin Hydrochloride 2 mg/mL, >240 minutes
Epirubicin HC1 (Ellence) 2 mg/mL, >240 minutes
Etoposide (Toposar) 20 mg/mL, >240 minutes
Fludarabine 25 mg/mL, >240 minutes
Fluorouracil 50 mg/mL, >240 minutes
Gemcitabine 38 mg/mL, >240 minutes
Idarubicin HCl 1 mg/mL, >240 minutes
lfosfamide 50 mg/mL, >240 minutes
Irinotecan 20 mg/mL, >240 minutes
Mechlorethamine HC1 1 mg/mL, >240 minutes
Melphalan 5 mg/mL, >240 minutes
Methotrexate 25 mg/mL, >240 minutes
Mitomycin C 0.5 mg/mL, >240 minutes
Mitoxantrone 2 mg/mL, >240 minutes
Paclitaxel (Taxol) 6 mg/mL, >240 minutes
Rituximab 10 mg/mL, >240 minutes
Thiotepa 10 mg/mL, 3.7 minutes
Trisenox 1 mg/mL . >240 minutes
Vincristine Sulfate 1 mg/mL, >240 minutes

Fentanyl tested as follows: Fentanyl citrate 100 mcg/2mL, >240 minutes

WARNING: Not for use with Carmustine or Thiotepa.

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

I cannot fulfill this request. The provided text is an FDA 510(k) clearance letter for examination gloves. It does not contain any information about acceptance criteria or a study proving a device meets acceptance criteria related to a medical imaging AI device or similar complex medical technology.

The text exclusively details the clearance of Latex Examination Gloves Powder Free (Ocean Blue and Natural White), citing regulation numbers, product codes, and the review process for market clearance. It mentions general controls, quality system regulations, UDI rules, and reporting of adverse events, all pertaining to the manufacturing and marketing of physical medical devices (gloves in this case), not performance studies of an AI algorithm or diagnostic device.

Therefore, I cannot extract the information required to answer your specific questions about acceptance criteria, study design, ground truth, or expert involvement, as this information is not present in the provided document.

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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.

Powder Free Latex Examination Gloves meets all the current specifications listed under the ASTM Specification D3578-05, Standard Specification for Rubber Examination Gloves. The principal operation and mechanism of this device is to prevent contamination between patient and examiner and this principle is achieved through testing of barrier, physical properties and other testing stated in the performance data. This device is for over-the counter single use.

The provided text describes the acceptance criteria and the study that proves the device meets the acceptance criteria for the Shandong Intco Medical Products Co., Ltd Latex Examination Gloves, Powder Free.

Here's a breakdown of the requested information:

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

The document provides two tables that fulfill this request:

• A "Technology Characteristic Comparison between the device and predicate device" table on page 4-5.
• A "Non-clinical Testing Summary" table on page 6.

Let's combine and summarize the relevant information from both into a single table for clarity. Note that some "acceptance criteria" are simply the standard reference, and the "reported device performance" indicates "Complied with the standard". For detailed numerical values, refer to the "Technology Characteristic Comparison" table.

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 does not explicitly state the sample sizes used for each specific test (e.g., how many gloves were tested for Freedom of Holes, or how many individuals for skin irritation). It only reports the average values or compliance statements.

The data provenance is not explicitly stated as retrospective or prospective for the non-clinical tests. The company, Shandong Intco Medical Products Co, Ltd, is located in China, suggesting the testing likely occurred there or was commissioned by them.

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 information is not applicable to the type of device and testing described. The device is a "Latex Examination Glove," and its performance is evaluated through physical, chemical, and biological non-clinical tests based on established international standards (ASTM, ISO). Expert interpretation of medical images or diagnoses is not involved in establishing the "ground truth" for glove performance. The "ground truth" here refers to the measured physical and chemical properties and biological reactions as defined by the standards.

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

Not applicable. As noted above, the testing involves non-clinical measurements against predefined standard specifications, not a subjective interpretation requiring adjudication by multiple experts.

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-assisted diagnostic tool or system that involves human readers.

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

Not applicable. The device is a physical product (medical glove), not an algorithm.

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

The ground truth used for evaluating the Latex Examination Gloves is based on established international and national standards and specifications for medical gloves. This includes:

• ASTM D3578-19 (Standard Specification for Rubber Examination Gloves) for physical properties.
• ASTM D6124-06 (Reapproved 2017) (Standard Test Method for Residual Powder on Medical Gloves) for residual powder.
• ASTM D5151-06 (Reapproved 2015) (Standard Test Method for Detection of Holes in Medical Gloves) for freedom of holes.
• ISO 10993-10:2010 (Biological Evaluation of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization) for biocompatibility.

The "ground truth" is therefore the objective measurement of the glove's characteristics against these well-defined and accepted standard limits.

8. The sample size for the training set

Not applicable. The device is a physical medical product, not an AI/ML algorithm that requires a training set. The performance data is from non-clinical testing of the manufactured product.

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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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 device is a class I latex patient examination gloves 21 CFR 880.6250, Patient Examination Glove, LYY made by surface treatment on the inner and anti-tack coating on outer surface. The process modifies the surface characteristics that assist the user in donning the gloves with ease without the use of any dusting or donning powder is substantially equivalent in safety and effectiveness to the predicate device.

They are ambidextrous and come in different sizes, Extra Small, Small, Medium, Large and Extra Large.

The provided document is a 510(k) Premarket Notification for a Latex Examination Glove. It is a regulatory submission to the FDA demonstrating substantial equivalence to a legally marketed predicate device. This document does not describe an AI/ML-driven medical device. Therefore, it does not contain the information requested about acceptance criteria and a study proving an AI/ML device meets acceptance criteria.

The questions posed relate to the development and validation of an AI/ML device, which typically involves data sets, expert labeling, ground truth establishment, and performance metrics like sensitivity, specificity, or AUC. The provided text, however, focuses on:

• Physical properties of rubber gloves: Dimensions, tensile strength, elongation, freedom from holes, residual powder, and protein content.
• Biocompatibility testing: Skin irritation, dermal sensitization, and acute systemic toxicity.
• Comparison to a predicate device: Highlighting similarities in intended use, materials, and compliance with standards.

Since the document is for a physical medical product (gloves) and not an AI/ML device, I cannot extract the information required to answer your specific questions.

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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.

It is the powder-free variation of the class I latex patient examination gloves made by on-line polymercoating and mild on-line chlorination process. The process modifies the surface characteristics and causes it to remain tack-free without the use of any dusting or donning powder.

The document is a 510(k) Premarket Notification for "Latex Examination Gloves Powder Free". It does not describe an AI/ML medical device, therefore, the requested information for acceptance criteria and study details for such a device is not applicable.

The document focuses on demonstrating substantial equivalence to a predicate device (K152593) for patient examination gloves.

However, I can extract the acceptance criteria and performance of the device based on the non-clinical tests mentioned, as they serve a similar purpose of demonstrating safety and effectiveness for this medical device.

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 sample sizes for each specific test (e.g., how many gloves were tested for length, thickness, or tensile strength). However, the tests were performed "as per ASTM D3578-05, Standard Specification for Rubber Examination Gloves and 21 CFR 800.20." These standards typically define the sampling plans. The data provenance is Malaysia, as the applicant, Careglove Global SDN BHD, is located in Seremban, Negeri Sembilan, Malaysia. The tests are non-clinical and would be considered prospective in the sense that they were conducted specifically for this submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is not an AI/ML device that requires expert ground truth for image or data interpretation. The ground truth for the glove's performance is established by objective measurements against established industry standards (ASTM D3578-05).

4. Adjudication method for the test set
Not applicable, as it's not an AI/ML device requiring human adjudication of performance. The performance is determined by direct physical and chemical measurements.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an AI/ML device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML device.

7. The type of ground truth used
The ground truth is based on established industry standards and regulatory requirements, specifically:

• ASTM D3578-05 (Standard Specification for Rubber Examination Gloves)
• 21 CFR 800.20 (dealing with devices that prevent contamination)
• ISO 10993-10 (Biological evaluation of medical devices - Tests for irritation and skin sensitization)

These standards define the acceptable performance limits for the characteristics tested.

8. The sample size for the training set
Not applicable. This is not an AI/ML device, so there is no "training set."

9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device, so there is no "training set" or ground truth for it. The ground truth for the device's performance is established by the aforementioned ASTM and ISO standards for physical characteristics and biocompatibility.

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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.

LATEX EXAMINATION GLOVE POWDER FREE

This document is a 510(k) premarket notification letter from the FDA regarding a Latex Examination Glove Powder Free. It does NOT contain information about acceptance criteria, device performance, a study, or any of the specific details requested in your prompt (such as sample size, data provenance, ground truth, or MRMC studies).

This document is solely an approval letter for a medical device that falls under general controls.

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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.

Powder Free Latex Patient Examination Glove, with Protein Content Labeling Claim, Chlorinated (Contains 50 Micrograms per dm2 of glove or Less of Water Extractable Protein) meets all the current specification for ASTM D3578-05 (2010).

The provided text is for a 510(k) Premarket Notification for a medical device, specifically a Powder Free Latex Patient Examination Glove. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, primarily through non-clinical performance data and comparison of technological characteristics, rather than extensive clinical studies as one might find for a novel diagnostic AI device.

Therefore, many of the typical acceptance criteria and study details requested (e.g., sample size for test set, number of experts for ground truth, adjudication method, MRMC studies, standalone algorithm performance, training set details) are not applicable to this type of device and submission. The "study" here refers to the testing performed to meet specific ASTM standards and biocompatibility requirements.

Here's a breakdown of the information that is applicable and how it relates to the acceptance criteria:

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are defined by existing ASTM standards and biocompatibility testing. The device's performance is reported as meeting these standards.

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

The document specifies that the device "meets all the current specification for ASTM D3578-05 (2010)" and refers to other ASTM and ISO standards for specific characteristics. Clinical data was "not needed for market cleared examination gloves."

• Sample Size for Test Set: The specific sample sizes for each test (e.g., pin-holes, dimensions, physical properties) are not detailed in this 510(k) summary. These would typically be specified within the individual ASTM and ISO standards referenced. For example, ASTM D5151-99 for freedom from pinholes often specifies a sample size based on the acceptable quality level (AQL).
• Data Provenance: The document does not explicitly state the country of origin for the data (e.g., where the tests were physically conducted) nor whether it was retrospective or prospective. Given the nature of performance testing against standards, it would be prospective testing of newly manufactured glove batches. The manufacturer is "Top Calibre Sdn Bhd" in Selangor, Malaysia, so the testing was likely conducted by or for them.

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

Not Applicable: This type of device does not involve a "ground truth" established by experts in a diagnostic or interpretive sense. The ground truth for performance characteristics is defined by the objective measurement criteria within the relevant ASTM and ISO standards (e.g., tensile strength, elongation, water leak rate, protein content measurement). Biocompatibility tests are performed by qualified laboratories and assessed against established toxicology criteria.

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 human-reviewed data, often in diagnostic imaging or clinical trials, to resolve discrepancies between readers. For physical and chemical tests of gloves, results are objectively measured against defined thresholds in the standards; there is no subjective interpretation 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 patient examination glove, not an AI-powered diagnostic tool. Therefore, MRMC studies and assessments of AI assistance are irrelevant.

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

Not Applicable: This device is a physical medical device (glove), not an algorithm or software. Standalone algorithm performance is not relevant.

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

The "ground truth" for this device's performance is established by objective measurements against predefined criteria and thresholds set forth in the referenced ASTM and ISO standards.

• For Dimensions, Physical Properties, Freedom from pin-holes, Powder Free Residue, Protein Content: The ground truth is the quantitative measurement of these properties (e.g., thickness, tensile strength, percentage of gloves passing water leak test, specific protein content in µg/dm²) compared to the specified limits in standards like ASTM D3578-05 (2010), ASTM D5151-99 (2006), ASTM D6124-06, and ASTM D5712-10.
• For Biocompatibility: The ground truth is determined by the results of standardized biological tests (Dermal Sensitization and Primary Skin Irritation Tests as per ISO 10993-10:2010), which assess the device's potential to cause adverse biological reactions. The "ground truth" in this context is the observation of whether a reaction occurs and its severity, interpreted against established toxicity criteria, leading to a "pass" or "fail" determination (e.g., "Not a contact skin sensitizer," "Not a primary skin irritant").

8. The sample size for the training set

Not Applicable: This device does not use machine learning or AI, 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, this question is not relevant.

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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.

Powdered Latex Patient Examination Glove with Protein Content Labeling Claim (Contains 200 Micrograms per dm2 of glove or Less of Water Extractable Protein) meets all the current specification for ASTM D3578-05 (2010).

Acceptance Criteria and Device Performance Study for K120693 - Powdered Latex Patient Examination Glove

This document describes the acceptance criteria and the study demonstrating that the "Powdered Latex Patient Examination Glove with Protein Content Labeling Claim (Contains 200 Micrograms per dm² of glove or Less of Water Extractable Protein)" (K120693) meets these criteria.

1. Table of Acceptance Criteria and Reported Device Performance

The device's performance was evaluated against established ASTM standards and ISO standards for biocompatibility.

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

The document does not explicitly state the sample sizes used for each specific test or the country of origin for the data. However, the evaluation relies on compliance with established ASTM and ISO standards, which typically involve specific sampling plans and test methods. The studies are non-clinical performance tests.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. For this type of medical device (patient examination gloves), the "ground truth" is established by adherence to recognized national and international consensus standards (ASTM and ISO), not by expert consensus on clinical data or image interpretation. The tests are laboratory-based and objective measurements.

4. Adjudication Method for the Test Set

Not applicable. The performance testing involves objective measurements against established standard specifications, not subjective interpretation requiring adjudication among experts.

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

Not applicable. This device is a patient examination glove, and its performance is assessed through non-clinical laboratory testing against physical, chemical, and biocompatibility standards. MRMC studies are typically relevant for diagnostic imaging or similar devices that involve human interpretation of results.

6. Standalone Performance Study

Yes, a standalone (algorithm only without human-in-the-loop performance) study was done in the sense that the device itself, a physical product, was subjected to a series of laboratory tests to evaluate its inherent characteristics against the specified standards. Human interaction is limited to conducting the tests according to the standard protocols and recording the objective results.

7. Type of Ground Truth Used

The ground truth used is based on established national and international consensus standards (ASTM and ISO). These standards define objective pass/fail criteria and test methodologies for dimensions, physical properties, freedom from pinholes, powder amount, protein content, and biocompatibility.

8. Sample Size for the Training Set

Not applicable. This device is a physical product, not an algorithm or AI model that requires a training set. The evaluation is based on direct testing of the manufactured product batches against standardized criteria.

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

Not applicable, as there is no "training set" for this device. The ground truth for evaluating the device's performance is established by the specified ASTM and ISO standards themselves, which outline the acceptable ranges and test methods.

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A powder-free patient examination glove is a disposable device intended for medical purposes worn on the examiner's hand or finger to prevent contamination between patient and examiner

Latex Examination Gloves Powder-Free (Black Color) and with protein content labeling claim(50 micrograms or less)

This document is a 510(k) premarket notification determination letter from the FDA for "Latex Examination Gloves Powder-Free (Black Color) and with Protein Content Labeling Claim (50 micrograms or less)". It does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the context of performance metrics like accuracy, sensitivity, or specificity.

Instead, the letter confirms that the device is "substantially equivalent" to legally marketed predicate devices. This means the FDA found that the new device is as safe and effective as a previously cleared device. The "acceptance criteria" in this context would primarily pertain to compliance with FDA regulations, good manufacturing practices, and performance characteristics (like protein content, physical properties such as tensile strength and elongation, and freedom from holes) that demonstrate substantial equivalence to predicate devices, rather than a statistical study proving clinical performance of an AI/ML diagnostic tool.

Therefore, I cannot provide the requested information from the provided text as it is not present in this type of FDA document.

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Latex Examination Glove Powder Free with Neoprene lined is a disposable device intended for medical purpose that is worn on examiner's hand to prevent contamination between patient and examiner.

Latex Examination Gloves Powder Free With Lined.

The provided text describes a 510(k) premarket notification for "Latex Examination Gloves Powder Free With Lined." This submission is for a medical device that does not involve an AI component or complex analytical software. Therefore, the questions related to AI performance, ground truth, expert adjudication, and multi-reader multi-case studies are not applicable.

The document focuses on demonstrating that the gloves meet established industry standards for physical properties and safety.

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

1. Table of Acceptance Criteria and Reported Device Performance

Notes:

• The document states that the performance data is "the same as mentioned immediately above," referring to the detailed table of dimensions and physical properties.
• The primary method of demonstrating acceptance is through a certification statement that the gloves meet or exceed the ASTM D 3578-01ae2 Standard and FDA pin hole requirements.

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

The document does not explicitly state the sample sizes used for testing any specific batch or lot of gloves. It refers to the ASTM D 3578-01ae2 Standard for latex examination gloves, which would outline the sampling plan for such tests.

• Sample Size: Not explicitly stated in the provided text.
• Data Provenance: The manufacturer is PT. Shamrock Manufacturing Corp. located in Medan, Indonesia. The testing would have been conducted by them or a contracted laboratory to demonstrate compliance with the ASTM standard. The data is retrospective in the sense that it represents the characteristics of manufactured gloves.

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

This question is not applicable. For medical gloves, "ground truth" is established by adherence to recognized international and national standards (e.g., ASTM standards) and regulatory requirements (e.g., FDA pinhole requirements). Testing is typically performed according to standardized protocols, and the results are compared against predefined criteria in these standards, not against expert consensus on individual "cases."

4. Adjudication Method for the Test Set

This question is not applicable. As explained above, for physical and chemical testing of gloves, results are typically objective measurements compared against specified quantitative criteria rather than subjective assessments 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

This question is not applicable. The device is a physical medical glove and does not involve AI or human readers for its intended use or evaluation.

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

This question is not applicable. The device is a physical medical glove and does not involve an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device is based on:

• Industry Standards: Specifically, the ASTM D 3578-01ae2 Standard for Latex Examination Gloves. This standard defines the acceptable ranges for dimensions, tensile strength, and elongation, as well as test methods.
• Regulatory Requirements: The FDA pinhole requirement for medical gloves, which specifies an Acceptable Quality Level (AQL) for watertight integrity.
• Labeling Claims: Verification that the product meets its stated specifications, including the protein content claim ("Contains ≤ 50 micrograms or less of total water extractable protein per gram").

8. The Sample Size for the Training Set

This question is not applicable. As this is not an AI/ML device, there is no "training set." The manufacturing process is controlled to consistently produce gloves that meet the specified standards.

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

This question is not applicable, as there is no "training set" for this type of device. The quality control and testing processes ensure that each batch of gloves (or a statistically significant sample from it) meets the established "ground truth" defined by the ASTM standard and FDA regulations.

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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.

Latex Patient Examination Glove, Powdcred Type II, Low Modulus, with extractable protein content labelling claim (200 microgram per gram of glove or less)

This document is a 510(k) clearance letter for "Latex Examination Gloves, Powdered Type II, Low Modulus with Extractable Protein Content Labeling Claim (200 Micrograms or Less)". It confirms that the device is substantially equivalent to legally marketed predicate devices.

However, this document does not contain information about acceptance criteria, device performance studies, or ground truth establishment typically found in detailed device validation reports.

The provided text focuses on the regulatory clearance process rather than technical performance data. Therefore, I cannot extract the requested information.

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