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510(k) Data Aggregation
(90 days)
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.
In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05, Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs:
Carmustine (BCNU) (3.3 mg/ml) has a minimum breakthrough time of 23.4 minute and Thiotepa (10.0 mg/ml) has a minimum breakthrough time of 77.5 minute. Warning statements has been included.
WARNING: DO NOT USE WITH CARMUSTINE WARNING: DO NOT USE WITH THIOTEPA
Powder-Free Nitrile Examination Gloves, Blue, Tested for Use With Chemotherapy Drugs
The provided text is a 510(k) premarket notification letter from the FDA regarding "Powder Free Nitrile Examination Gloves, Blue, Tested for use with Chemotherapy Drugs." This document outlines the FDA's substantial equivalence determination for this medical device.
It does not contain information about acceptance criteria and a study proving a device meets those criteria in the context of an AI-powered diagnostic or similar system.
Instead, the document details the "Indications for Use" for the gloves, which includes their general purpose as examination gloves and their tested performance against specific chemotherapy drugs according to ASTM D6978-05.
Therefore, I cannot extract the requested information (acceptance criteria table, sample sizes, expert qualifications, adjudication, MRMC study, standalone performance, ground truth types, or training set details) from the provided text, as these are not relevant to this type of medical device submission.
The table in the document you provided describes the "Minimum Breakthrough Detection Time (Minutes)" for different chemotherapy drugs when tested with the gloves. This is a performance specification for the gloves regarding chemical permeation, not acceptance criteria for an AI product.
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(50 days)
The Powder Free Nitrile Examination Gloves, Blue, Test For Use With Chemotherapy Drugs 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. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 (2019) Standard Practice for Assessment of Medical gloves to Permeation by Chemotherapy Drugs.
The Powder Free Nittile Examination Gloves, Violet Blue, Test For Use With Chemotherapy Drugs 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. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 (2019) Standard Practice for Assessment of Medical gloves to Permeation by Chemotherapy Drugs.
Not Found
This document describes the FDA clearance for Powder Free Nitrile Examination Gloves (Blue and Violet Blue) tested for use with chemotherapy drugs. It is a 510(k) premarket notification (K220228). The core of the information provided for acceptance criteria and device performance relates to the gloves' resistance to permeation by various chemotherapy drugs.
Here's an analysis of the provided information in the requested format:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criterion, though not explicitly stated as a pass/fail threshold, is implied by the standard ASTM D6978-05 (2019) which assesses the permeation and provides breakthrough detection times. The performance is presented as the actual breakthrough detection time for each drug. Generally, a longer breakthrough time indicates better protection. The warnings for Carmustine (BCNU) and Thio Tepa highlight cases where the performance is considered critically low.
| Test Chemotherapy Drug | Concentration | Acceptance Criteria (Implied by standard and intended use) | Reported Device Performance (Breakthrough Detection Time in Minutes) - Blue Gloves | Reported Device Performance (Breakthrough Detection Time in Minutes) - Violet Blue Gloves |
|---|---|---|---|---|
| Carmustine (BCNU) | 3.3 mg/ml (3,300 ppm) | Longer breakthrough time is better; Warning for low times | 22.4 | 23.5 |
| Cisplatin | 1.0 mg/ml (1,000 ppm) | Longer breakthrough time is better | >240 | >240 |
| Cyclophosphamide (Cytoxan) | 20 mg/ml (20,000 ppm) | Longer breakthrough time is better | >240 | >240 |
| Dacarbazine | 10 mg/ml (10,000 ppm) | Longer breakthrough time is better | >240 | >240 |
| Doxorubicin HCl | 2.0 mg/ml (2,000 ppm) | Longer breakthrough time is better | >240 | >240 |
| Etoposide | 20.0 mg/ml (20,000 ppm) | Longer breakthrough time is better | >240 | >240 |
| Fluorouracil | 50.0 mg/ml (50,000 ppm) | Longer breakthrough time is better | >240 | >240 |
| Methotrexate | 25.0 mg/ml (25,000 ppm) | Longer breakthrough time is better | >240 | >240 |
| Mitomycin C | 0.5 mg/ml (500 ppm) | Longer breakthrough time is better | >240 | >240 |
| Paclitaxel | 6.0 mg/ml (6,000 ppm) | Longer breakthrough time is better | >240 | >240 |
| Thio Tepa | 10.0 mg/ml (10,000 ppm) | Longer breakthrough time is better; Warning for low times | 73.1 | 66.6 |
| Vincristine Sulfate | 1.0 mg/ml (1,000 ppm) | Longer breakthrough time is better | >240 | >240 |
| Warning Notes | The document explicitly states: "Don't use with either Carmustine (BCNU) or Thio Tepa" for both glove types due to low permeation times. | The document explicitly states: "Don't use with either Carmustine (BCNU) or Thio Tepa" for both glove types due to low permeation times. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for testing each drug (e.g., how many gloves were tested per drug). It indicates that the testing was performed "in accordance with ASTM D6978-05 (2019) Standard Practice for Assessment of Medical gloves to Permeation by Chemotherapy Drugs." This standard would define the appropriate sample sizes and testing methodologies.
The data provenance is from a laboratory study evaluating the permeation of chemotherapy drugs through the gloves. The country of origin of the data is not specified, but the manufacturer is based in China. The study is prospective in nature as it involves planned testing of the device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of study does not typically involve human experts to establish "ground truth" in the clinical sense (e.g., radiologists interpreting images). The "ground truth" for this device is the objective measurement of chemical permeation according to a standardized method (ASTM D6978-05). The experts involved would be laboratory technicians and chemists skilled in conducting these specific permeation tests and interpreting the results as per the ASTM standard. Their qualifications would likely include laboratory certifications and experience with chemical testing and material science, not clinical medical expertise.
4. Adjudication Method for the Test Set
No adjudication method is relevant here as the output is an objective, quantitative measurement (breakthrough time) according to a standardized test. There is no subjective human interpretation that would require an adjudication process.
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
No MRMC study was done, nor is it applicable to this type of device. This device is a physical barrier (gloves), not an AI diagnostic or assistive technology.
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 product (gloves), not an algorithm or AI. The performance testing is "standalone" in the sense that the gloves are tested directly, without human intervention during the permeation assay itself.
7. The Type of Ground Truth Used
The ground truth used is objective laboratory measurement according to a recognized industry standard (ASTM D6978-05). This standard defines how to assess the resistance of medical gloves to permeation by chemotherapy drugs, yielding quantitative data (breakthrough detection time).
8. The Sample Size for the Training Set
This question is not applicable. The device is a physical product (gloves) that undergoes direct performance testing, not a machine learning model that requires a "training set."
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.
Ask a specific question about this device
(137 days)
The Powder Free Nitrile Examination Gloves, Blue, Test For Use With Chemotherapy Drugs 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. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 (2019) Standard Practice for Assessment of Medical gloves to Permeation by Chemotherapy Drugs.
The powder free Nitrile Examination glove is a disposable Class 1 medical device made of Nitrile rubber, and is intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner. The principal operation of the medical device to provide single use barrier protection for the wearer and the device meets all the requirement specifications for Barrier Protection, tensile properties as defined in ASTM D6319-19, Standard specification for Nitrile Examination Gloves for medical Application.
The provided document describes the acceptance criteria and performance data for "Powder Free Nitrile Examination Gloves, Blue, Test For Use With Chemotherapy Drugs" (K213306), a Class I medical device.
Note: The document is for a medical device (gloves), not an AI/Software as a Medical Device (SaMD). Therefore, many of the typical acceptance criteria and study components for AI/SaMD (e.g., ground truth establishment by experts, MRMC studies, effect size of AI assistance, training set details) are not applicable or provided in this context. The information provided focuses on the physical and chemical performance of the gloves.
Here's an breakdown of the available information regarding acceptance criteria and device performance:
1. A table of acceptance criteria and the reported device performance
The primary acceptance criteria are based on various ASTM and ISO standards for examination gloves and chemotherapy drug permeation.
| Test Method | Purpose | Acceptance Criteria | Reported Device Performance and Results |
|---|---|---|---|
| ASTM D5151 | Water tightness Test for Detection of Holes | Meet the requirements of ASTM D5151 AQL 2.5 | Pass: Total 200 pcs of gloves were tested, 0 pcs rejected. |
| ASTM D6319 | Physical Dimensions Test | Length(mm): S: ≥220 mm; M/L/XL: ≥230 mm.Width(mm): S:80±10mm; M:95±10mm; L: 110±10mm; XL: 120±10mm.Thickness (mm): Finger: ≥0.05, Palm: ≥0.05 | Pass: 13 pcs each size, total 65 pcs of gloves were tested, 0 pcs rejected. |
| ASTM D412 | Physical properties (Tensile Strength & Ultimate Elongation) | Before Aging: Tensile Strength ≥14MPa, Ultimate Elongation ≥500%After Aging: Tensile Strength ≥14MPa, Ultimate Elongation ≥500% | Pass: 13 pcs each size, total 65 pcs of gloves were tested, 0 pcs rejected. |
| ASTM D6124 | Residual Powder Content | Meet the requirements of ASTM D6124 < 2.0mg | Pass: 5 pcs each size, total 25 pcs of gloves were tested, 0 pcs rejected. |
| ISO 10993-10 | Skin irritation | non-irritating | Pass: The test result showed that the response of the test article extract was categorized as negligible under the test condition. |
| ISO 10993-10 | Skin Sensitization | non-sensitizing | Pass: Under the conditions of this study, the test article extract showed no significant evidence of causing skin sensitization in the guinea pig. The positive rate of sensitization was 0%. No evidence of skin sensitization in guinea pigs was found. |
| ISO 10993-5 | Cytotoxicity | Non-cytotoxicity. | Pass: Under the conditions of this study, the test article extract did not show potential toxicity to L929 cells. |
| ASTM D6978-05 (2019) | Chemotherapy Drug Permeation (Breakthrough Detection Time) | Varies by drug (e.g., >240 minutes for most, with specific lower times for Carmustine and Thio Tepa) | |
| Carmustine (BCNU) | 3.3 mg/ml (3,300 ppm) | No explicit minimum acceptance criterion listed for Carmustine, but the reported value is a key performance metric. | 16.9 minutes |
| Cisplatin | 1.0 mg/ml(1,000 ppm) | >240 minutes | >240 minutes |
| Cyclophosphamide (Cytoxan) | 20 mg/ml(20,000 ppm) | >240 minutes | >240 minutes |
| Dacarbazine | 10 mg/ml(10,000 ppm) | >240 minutes | >240 minutes |
| Doxorubicin HCl | 2.0 mg/ml(2,000 ppm) | >240 minutes | >240 minutes |
| Eotoside (Toposar) | 20.0 mg/ml(20,000 ppm) | >240 minutes | >240 minutes |
| Fluorouracil | 50.0 mg/ml(50,000 ppm) | >240 minutes | >240 minutes |
| Mechlorethamine | 1.0 mg/ml(1,000 ppm) | >240 minutes | >240 minutes |
| Methotrexate | 25.0 mg/ml(25,000 ppm) | >240 minutes | >240 minutes |
| Mitomycin C | 0.5 mg/ml(500 ppm) | >240 minutes | >240 minutes |
| Paclitaxel (Taxol) | 6.0 mg/ml(6,000 ppm) | >240 minutes | >240 minutes |
| Thio Tepa | 10.0 mg/ml(10,000 ppm) | No explicit minimum acceptance criterion listed for Thio Tepa, but the reported value is a key performance metric. | 22.6 minutes |
| Vincristine Sulfate | 1.0 mg/ml(1,000 ppm) | >240 minutes | >240 minutes |
2. Sample sizes used for the test set and the data provenance
- ASTM D5151 (Water tightness): 200 pieces of gloves.
- ASTM D6319 (Physical Dimensions): 13 pieces for each size (total 65 pieces: S, M, L, XL, and presumably X-Small from the comparison table, although the specific breakdown adds up to 5 sizes * 13 = 65).
- ASTM D412 (Physical Properties): 13 pieces for each size (total 65 pieces).
- ASTM D6124 (Residual Powder Content): 5 pieces for each size (total 25 pieces).
- ISO 10993-10 (Skin irritation/sensitization) & ISO 10993-5 (Cytotoxicity): The specific number of test subjects (e.g., guinea pigs for sensitization, L929 cells for cytotoxicity) is not explicitly stated, but standard animal models and cell lines are typically used.
- ASTM D6978-05 (Chemotherapy Drug Permeation): The specific sample size for each drug permeation test is not explicitly stated in this summary. However, these are bench tests.
Data Provenance: The document does not specify the country of origin for the testing data beyond the manufacturer being in China. The tests are "Performance Testing (Bench)" and "Biocompatibility Testing," indicating they are laboratory-based studies. The nature of these tests means they are prospective in the sense that the testing was conducted specifically to evaluate the performance of these gloves against the specified standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This section is not applicable as the device is a physical medical glove and not an AI/Software as a Medical Device (SaMD) that would rely on expert interpretation of medical images or data for ground truth. The "ground truth" for these tests is the objective measurement against established physical/chemical standards (e.g., a hole detected by water, a specific tensile strength value, a chemical permeation time).
4. Adjudication method for the test set
This is not applicable. The tests are objective measurements against established standards, not subjective interpretations requiring reader 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 is not applicable. This is a device (glove) that does not involve human readers interpreting data or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. This is a physical device, not an algorithm.
7. The type of ground truth used
The ground truth used for these studies is based on accepted international and national consensus standards for medical gloves and their performance (ASTM D5151, ASTM D6319, ASTM D412, ASTM D6124, ISO 10993-10, ISO 10993-5, and ASTM D6978-05). It is not expert consensus, pathology, or outcomes data in the typical sense of a diagnostic medical device. It's objective measurement against defined physical and chemical criteria.
8. The sample size for the training set
This is 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
This is not applicable for the reasons stated above.
Ask a specific question about this device
(222 days)
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 as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
It is the powder-free variation of the class I latex patient examination gloves made by on-line polymer-coating and mild on-line chlorination process modifies the surface characteristics and causes it to remain tack-free without the use of any dusting or donning powder.
This is a 510(k) summary for a medical device (Powder Free Nitrile Examination Gloves, Blue, Chemotest), not an AI/ML device. Therefore, the sections regarding AI/ML device assessment criteria (such as sample size for test/training set, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and ground truth types) are not applicable.
The document focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance and biocompatibility testing.
Here's the relevant information extrapolated from the document regarding acceptance criteria and performance:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Standard | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Freedom From Holes | ASTM D6319-19, ASTM D5151-19 | Inspection level G-I, AQL 2.5 | Pass |
| Dimension | ASTM D6319-19 | Length, min. (mm): XSmall 220, Small 220, Medium 230, Large 230, XLarge 230 | Pass (Meets requirements for all sizes) |
| Thickness, min. (mm): 0.05 (palm, finger) | Pass (Meets 0.05mm min) | ||
| Width, ± 10 (mm): XSmall 70, Small 80, Medium 95, Large 110, XLarge 120 | Pass (Meets requirements for all sizes) | ||
| Physical Properties (Before Aging) | ASTM D6319-19 | Tensile Strength: 14 MPa min. | Pass (Meets 14MPa min.) |
| Ultimate Elongation: 500 % min. | Pass (Meets 500% min.) | ||
| Physical Properties (After Accelerated Aging) | ASTM D6319-19 | Tensile Strength: 14 MPa min. | Pass (Meets 14MPa min.) |
| Ultimate Elongation: 400 % min. | Pass (Meets 400% min.) | ||
| Residual Powder Content | ASTM D6319-19, ASTM D6124-06 | Not more than 2 mg per glove | Pass (Meets 2mg/glove max.) |
| Biocompatibility - Primary Skin Irritation Test | ISO 10993-10 | No Irritation | No irritant response |
| Biocompatibility - Skin Sensitization Test | ISO 10993-10 | No Irritation | No skin sensitization effect |
| Biocompatibility - In Vitro Cytotoxicity Test | ISO 10993-5:2009 | (No specific numerical criteria, evaluated for reactivity) | Moderate cytotoxicity reactivity at 6.0 cm²/mL; No cytotoxicity reactivity at 3.0 cm²/mL |
| Biocompatibility - Acute Systemic Toxicity | ISO 10993-11 | (No specific numerical criteria, evaluated for adverse biological reactions) | No adverse biological reaction |
| Chemotherapy Drugs Permeation Time | ASTM D6978-05 | (Breakthrough detection time in minutes per drug) | Carmustine (BCNU): 22.6 min (WARNING: Not recommended for use) Cisplatin: >240 min Cyclophosphamide (Cytoxan): >240 min Dacarbazine: >240 min Doxorubicin HCL: >240 min Etoposide: >240 min Fluorouracil: >240 min Ifosfamide: >240 min Mitoxantrone: >240 min Paclitaxel: >240 min Thio Tepa: 43.9 min (WARNING: Not recommended for use) Vincristine Sulfate: >240 min |
2. Sample size 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 for each non-clinical test (e.g., number of gloves tested for dimensions, holes, or physical properties). However, it implies that the testing was conducted according to the specified ASTM and ISO standards, which would dictate appropriate sample sizes for each test method.
The data provenance is not explicitly stated in terms of country of origin of the testing data itself, but the applicant is Careglove Global SDN BHD from Malaysia. The studies are non-clinical, laboratory-based tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable, as this is for a physical medical device (examination gloves) and not an AI/ML diagnostic or predictive device requiring ground truth from human experts. The "truth" is established by physical measurement against standard specifications.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This concept applies primarily to AI/ML clinical studies where human readers might adjudicate discrepancies or define ground truth. For physical device testing, results are measured and compared against established standards.
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, as 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, as this is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" or reference values for device performance are defined by recognized international and national standards:
- ASTM D6319-19 (Standard Specification for Nitrile Examination Gloves for Medical Application)
- ASTM D5151-19 (Standard Test Method for Detection of Holes in Medical Gloves)
- ASTM D6124-06 (Standard Test Method for Residue on Medical Gloves)
- ASTM D6978-05 (Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs)
- ISO 10993-10 (Biological evaluation of medical devices – Part 10: Tests for irritation and skin sensitization)
- ISO 10993-5:2009 (Biological evaluation of medical devices – Part 5: Tests for in vitro cytotoxicity)
- ISO 10993-11 (Biological evaluation of medical devices – Part 11: Tests for systemic toxicity)
The device's performance is compared directly to the specifications outlined in these standards.
8. The sample size for the training set
Not applicable, as this is not an AI/ML device and therefore does not have a "training set."
9. How the ground truth for the training set was established
Not applicable, as this is not an AI/ML device and therefore does not have a "training set" with established ground truth.
Ask a specific question about this device
(186 days)
The Powder Free Nitrile Examination Gloves, Blue, Tested for Use with Chemotherapy Drugs 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 was tested for use with chemotherapy drugs in accordance with ASTM D6978-05 (Reapproved 2013) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
The following chemicals have been tested with proposed device.
| Test Chemotherapy Drug | Concentration | Breakthrough Detection Time in Minutes |
|---|---|---|
| *Carmustine (BCNU) | 3.3 mg/ml (3,300 ppm) | 15.1 |
| Cisplatin | 1.0 mg/ml(1,000 ppm) | >240 |
| Dacarbazine(DTIC) | 10.0 mg/ml (10,000ppm) | >240 |
| Cyclophosphamide (Cytoxan) | 20 mg/ml(20,000 ppm) | >240 |
| Doxorubicin Hydrochloride | 2.0 mg/ml(2,000 ppm) | >240 |
| Etoposide (Toposar) | 20.0 mg/ml(20,000 ppm) | >240 |
| Fluorouracil | 50.0 mg/ml(50,000 ppm) | >240 |
| Mechlorethamine HCl | 1.0 mg/ml(1,000 ppm) | >240 |
| Methotrexate | 25.0 mg/ml(25,000 ppm) | >240 |
| Mitomycin C | 0.5 mg/ml(500 ppm) | >240 |
| Paclitaxel (Taxol) | 6.0 mg/ml(6,000 ppm) | >240 |
| *Thiotepa | 10.0 mg/ml(10,000 ppm) | 15.1 |
| Vincristine Sulfate | 1.0 mg/ml(1,000 ppm) | >240 |
The Powder Free Nitrile Examination Gloves, Blue, Tested for Use with Chemotherapy Drugs 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.
This document is a 510(k) premarket notification for "Powder Free Nitrile Examination Gloves, Blue, Tested for Use with Chemotherapy Drugs." It's a regulatory document for a medical device and not a study proving the device meets acceptance criteria for an AI/CADe product.
Therefore, the requested information about acceptance criteria for an AI/CADe study, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set details are not applicable to this document.
However, I can extract the acceptance criteria and performance related to the chemotherapy drug permeation testing for the gloves, as described in the document.
Here's the relevant information from the document as it pertains to the device (gloves), not an AI/CADe system:
1. A table of acceptance criteria and the reported device performance:
The document states that the device was "tested for use with chemotherapy drugs in accordance with ASTM D6978-05 (Reapproved 2013) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs." This standard would define the acceptance criteria for breakthrough detection time. While the specific numerical acceptance criteria (e.g., "must be >X minutes") are not explicitly stated in this document, the reported performance is the "Breakthrough Detection Time in Minutes." Implicitly, a longer breakthrough time is better.
| Test Chemotherapy Drug | Concentration | Reported Breakthrough Detection Time in Minutes |
|---|---|---|
| *Carmustine (BCNU) | 3.3 mg/ml (3,300 ppm) | 15.1 |
| Cisplatin | 1.0 mg/ml (1,000 ppm) | >240 |
| Dacarbazine (DTIC) | 10.0 mg/ml (10,000 ppm) | >240 |
| Cyclophosphamide (Cytoxan) | 20 mg/ml (20,000 ppm) | >240 |
| Doxorubicin Hydrochloride | 2.0 mg/ml (2,000 ppm) | >240 |
| Etoposide (Toposar) | 20.0 mg/ml(20,000 ppm) | >240 |
| Fluorouracil | 50.0 mg/ml(50,000 ppm) | >240 |
| Mechlorethamine HCl | 1.0 mg/ml(1,000 ppm) | >240 |
| Methotrexate | 25.0 mg/ml(25,000 ppm) | >240 |
| Mitomycin C | 0.5 mg/ml(500 ppm) | >240 |
| Paclitaxel (Taxol) | 6.0 mg/ml(6,000 ppm) | >240 |
| *Thiotepa | 10.0 mg/ml(10,000 ppm) | 15.1 |
| Vincristine Sulfate | 1.0 mg/ml(1,000 ppm) | >240 |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the sample size used for testing each chemotherapy drug. This is a regulatory submission for a medical device (gloves), not an AI algorithm. The provenance would be from laboratory testing according to the ASTM D6978-05 standard.
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. This is a physical product (gloves) tested for chemical permeation, not an AI algorithm requiring expert ground truth in a clinical context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This pertains to the resolution of disagreements among experts in AI/clinical studies, which is not relevant here.
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/CADe product.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/CADe product.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the gloves' performance is established by the laboratory measurement of chemotherapy drug permeation using the standardized method ASTM D6978-05. This involves quantitative detection of the drug passing through the glove material.
8. The sample size for the training set
Not applicable. This is not an AI/CADe product, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable. This is not an AI/CADe product, so there is no "training set" or corresponding ground truth establishment.
Ask a specific question about this device
(119 days)
The Powder Free Nitrile Examination Gloves, Blue, Tested for Use with Chemotherapy Drugs 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 was tested for use with chemotherapy drugs in accordance with ASTM D6978-05 (Reapproved 2013) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
Powder Free Nitrile Examination Gloves, Blue, Tested for Use with Chemotherapy Drugs
The document describes the FDA 510(k) clearance for "Powder Free Nitrile Examination Gloves, Blue, Tested for Use with Chemotherapy Drugs" and provides details about the testing conducted to support its substantial equivalence.
Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The core of the study described relates to the glove's resistance to permeation by chemotherapy drugs. The acceptance criterion is implicit in the testing standard used, ASTM D6978-05 (Reapproved 2013), which generally aims for a breakthrough detection time that is sufficient for practical use in a clinical setting (often implying a minimum of 30 minutes, or longer for most drugs).
| Test Chemotherapy Drug | Concentration | Acceptance Criteria (Implied by standard and industry practice) | Reported Device Performance (Breakthrough Detection Time in Minutes) |
|---|---|---|---|
| Carmustine (BCNU) | 3.3 mg/ml (3,300 ppm) | Breakthrough > 30 minutes (typical for critical drugs) | 35.3 |
| Cisplatin | 1.0 mg/ml (1,000 ppm) | Breakthrough > 240 minutes (ideal for extended exposure) | >240 |
| Cyclophosphamide (Cytoxan) | 20 mg/ml (20,000 ppm) | Breakthrough > 240 minutes (ideal for extended exposure) | >240 |
| Doxorubicin Hydrochloride | 2.0 mg/ml (2,000 ppm) | Breakthrough > 240 minutes (ideal for extended exposure) | >240 |
| Etoposide (Toposar) | 20.0 mg/ml (20,000 ppm) | Breakthrough > 240 minutes (ideal for extended exposure) | >240 |
| Fluorouracil | 50.0 mg/ml (50,000 ppm) | Breakthrough > 240 minutes (ideal for extended exposure) | >240 |
| Mechlorethamine HCl | 1.0 mg/ml (1,000 ppm) | Breakthrough > 240 minutes (ideal for extended exposure) | >240 |
| Methotrexate | 25.0 mg/ml (25,000 ppm) | Breakthrough > 240 minutes (ideal for extended exposure) | >240 |
| Mitomycin C | 0.5 mg/ml (500 ppm) | Breakthrough > 240 minutes (ideal for extended exposure) | >240 |
| Paclitaxel (Taxol) | 6.0 mg/ml (6,000 ppm) | Breakthrough > 240 minutes (ideal for extended exposure) | >240 |
| Thiotepa | 10.0 mg/ml (10,000 ppm) | Breakthrough > 30 minutes (typical for critical drugs) | 29.2 |
| Vincristine Sulfate | 1.0 mg/ml (1,000 ppm) | Breakthrough > 240 minutes (ideal for extended exposure) | >240 |
Note: For FDA 510(k) clearances, performance is compared to a predicate device and/or recognized standards. The "acceptance criteria" here are inferred from the standard and the reported results within the context of safe medical device use. For chemotherapy gloves, the general expectation is that the breakthrough time should be sufficient to allow safe handling, typically indicating more than 30 minutes, and ideally much longer (e.g., >240 minutes) for many drugs. The results show that for most listed drugs, the glove exceeded 240 minutes, while for Carmustine and Thiotepa, it met or nearly met a 30-minute threshold.
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for testing each chemotherapy drug. The testing was performed in accordance with ASTM D6978-05 (Reapproved 2013). This standard specifies the methodology for assessing permeation, which would include details on the number of specimens to be tested per drug, but this specific detail is not provided in the publicly available 510(k) letter.
Data Provenance: The study was conducted by Blue Sail Medical Co.,Ltd, located in Zibo, CN (China). The data is prospective in nature, as it involves laboratory testing of the manufactured device to assess its performance against a standard.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This section is not applicable to this type of device and study. The "ground truth" for chemical permeation testing is established by laboratory measurement using standardized methods (ASTM D6978-05), not by expert consensus or interpretation of clinical data. The "experts" would be the chemists or technicians performing and verifying the lab tests, who would have qualifications in analytical chemistry and material science.
4. Adjudication Method for the Test Set
This is not applicable. Adjudication methods (like 2+1 or 3+1) are typically used in clinical studies involving interpretation of medical images or data by multiple human readers. This study is a laboratory performance test based on physical and chemical properties.
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 relates to diagnostic accuracy or clinical effectiveness involving human readers and interpretations, which is not relevant to the chemical permeation resistance of gloves.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done
This question is irrelevant to the device. "Standalone performance" refers to the performance of an AI algorithm without human input. The device is a physical medical glove, not an algorithm.
7. The Type of Ground Truth Used
The ground truth used is laboratory measurement data based on the standardized methodology of ASTM D6978-05 (Reapproved 2013). This standard defines how "breakthrough detection time" is measured, which is a quantified performance metric.
8. The Sample Size for the Training Set
This is not applicable. There is no "training set" in the context of physical medical devices like gloves. Training sets are relevant for machine learning algorithms.
9. How the Ground Truth for the Training Set Was Established
This is not applicable as there is no training set for a physical medical device.
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(85 days)
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 polymer-coating and mild on-line chlorination process modifies the surface characteristics and causes it to remain tackfree without the use of any dusting or donning powder.
Based on the provided document, the device in question is Powder Free Nitrile Examination Gloves, Blue (colored). This document is a 510(k) Summary for a medical device which typically focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a clinical study proving device performance against specific acceptance criteria in the context of an AI-powered diagnostic device.
Therefore, many of the requested elements for an AI device (like human reader improvement with AI assistance, standalone performance, training set details, expert qualifications for ground truth) are not applicable to this type of device and submission.
However, I can extract the acceptance criteria and performance data for the physical and biological characteristics of the gloves as presented in the "Summary of the Technological Characteristic" section.
Here's the breakdown:
1. A table of acceptance criteria and the reported device performance
| Characteristic | Acceptance Criteria (Predicate / Subject Device) | Reported Device Performance (Subject Device) |
|---|---|---|
| Dimension | ||
| Length (size: XSmall) | Meet 220mm min | Meet 220mm min |
| Length (size: Small) | Meet 220mm min | Meet 220mm min |
| Length (size: Medium) | Meet 230mm min | Meet 230mm min |
| Length (size: Large) | Meet 230mm min | Meet 230mm min |
| Length (size: XLarge) | Meet 230mm min | Meet 230mm min |
| Thickness (palm) | Meet 0.05mm min | Meet 0.05mm min |
| Thickness (finger) | Meet 0.05mm min | Meet 0.05mm min |
| Width (size: XSmall) | Meet 70 ± 10 mm | Meet 70 ± 10 mm |
| Width (size: Small) | Meet 80 ± 10 mm | Meet 80 ± 10 mm |
| Width (size: Medium) | Meet 95 ± 10 mm | Meet 95 ± 10 mm |
| Width (size: Large) | Meet 110 ± 10 mm (Subject); 111 ± 10 mm (Predicate) | Meet 110 ± 10 mm |
| Width (size: XLarge) | Meet 120 ± 10 mm | Meet 120 ± 10 mm |
| Physical Properties | ||
| (Before Ageing) Tensile Strength | Meet 14MPa min. | Meet 14MPa min. |
| (Before Ageing) Elongation | Meet 500% min | Meet 500% min |
| (After Aging) Tensile Strength | Meets 14MPa min | Meets 14MPa min |
| (After Aging) Elongation | Meet 400% min. | Meet 400% min. |
| Water Leak Test (Before Aging) | Meet AQL 1.5 | Meet AQL 1.5 |
| Water Leak Test (After Aging) | Meet AQL 2.5 | Meet AQL 2.5 |
| Residual Powder Content | Meet 2mg/glove max. | Meet 2mg/glove max. |
| Biocompatibility Test | ||
| Primary Skin Irritation Test | Passes; No irritant response | Passes; No irritant response |
| Skin Sensitization Test | Passes; No skin sensitization effect | Passes; No skin sensitization effect |
2. Sample sized used for the test set and the data provenance:
The document does not specify the exact sample sizes used for each test (e.g., how many gloves were tested for length, tensile strength, or water leaks). It simply states that the subject device "Meet[s]" or "Passes" the criteria. The provenance of the data is not explicitly stated beyond being presented in a submission from Careglove Global Sdn Bhd, Malaysia, implying the testing was conducted to support their device. It's standard for these types of tests to be prospective, laboratory-based evaluations.
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 physical product (examination gloves), not an AI-powered diagnostic tool requiring expert interpretation for "ground truth". The performance criteria are physical and chemical measurements or biological response assessments, not based on expert consensus.
4. Adjudication method for the test set:
Not applicable for the same reasons as #3. Quality control of physical properties does not typically involve expert 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 not an AI device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an AI device. The "standalone performance" is the inherent physical and chemical properties of the glove itself.
7. The type of ground truth used:
The "ground truth" for the physical and chemical properties of the gloves is established by standardized laboratory testing methods (e.g., likely conforming to ASTM standards like D6310, as mentioned in the document). For biocompatibility, the ground truth is established by the biological response observed in appropriate in vivo or in vitro models as per standard biocompatibility testing protocols.
8. The sample size for the training set:
Not applicable. This is not an AI device that requires a training set.
9. How the ground truth for the training set was established:
Not applicable. This is not an AI device.
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(88 days)
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.
POWDER-FREE NITRILE EXAMINATION GLOVES, BLUE AND BLACK
The provided document is a 510(k) premarket notification letter from the FDA for Powder-Free Nitrile Examination Gloves. This type of document is a regulatory approval for a medical device and therefore primarily focuses on compliance with regulations and substantial equivalence to a predicate device.
It does not contain the detailed information required to describe acceptance criteria and a study proving a device meets those criteria in the context of an AI/ML medical device. The document is for a physical patient examination glove, not a software or AI-driven device.
Therefore, I cannot extract the requested information regarding:
- A table of acceptance criteria and reported device performance
- Sample size and data provenance for a test set
- Number and qualifications of experts for ground truth establishment
- Adjudication method for the test set
- MRMC comparative effectiveness study details
- Standalone performance details
- Type of ground truth used
- Sample size and ground truth establishment for the training set
This document pertains to the regulatory clearance of a physical medical device (gloves) and such information is not applicable or present within this text.
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(69 days)
A patient examination glove is disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
The tested chemotherapy drugs and their breakthrough detection times are as follows:
| Chemotherapy Drug | Average BDT |
|---|---|
| Fluorouracil | >240 min. |
| Etoposide (Toposar) | >240 min. |
| Cyclophosphamide (Cytoxan) | >240 min. |
| Carmustine | 2.03 min. |
| Thiotepa | 25.23 min. |
| Paclitaxel (Taxol) | >240 min. |
| Doxorubicin Hydrochloride | >240 min. |
| Dacarbazine (DTIC) | >240 min. |
| Cisplatin | >240 min. |
| Please note that Carmustine and Thiotepa have extremely low permeation times of less than 30 minutes. |
Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Polymer Patient Examination Gloves, 80 LZA, and meets all requirements of ASTM standard D 6319-00a (2005)e1.
The provided text describes a 510(k) premarket notification for "Syntex Healthcare Products Co., Ltd Powder Free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs (Blue)". This is a medical device approval application, not a study of an AI/ML device. Therefore, the specific questions related to AI/ML device performance, such as sample sizes for test sets, expert ground truth, MRMC studies, and standalone algorithm performance, are not applicable.
However, I can extract the acceptance criteria and performance data for this device as it relates to the non-clinical tests conducted.
1. A table of acceptance criteria and the reported device performance
The acceptance criteria are generally established by recognized standards like ASTM D 6319-00a (2005)e1, ASTM D6124-06, ISO 10993 Part 10, and 16CFR 1500.41/1500.3. The "Performance Results" column indicates if the device meets these standards.
| Characteristics | Applicable Recognized Standards | Reported Device Performance |
|---|---|---|
| Dimensions | ASTM D 6319-00a (2005)e1 | Meets |
| Physical Properties | ASTM D 6319-00a (2005)e1 | Meets |
| Freedom from holes | (FDA Pinhole requirements) | Meets |
| Residual Powder Test | ASTM D 6319-00a (2005)e1, ASTM D6124-06 | Meets |
| Primary Skin Irritation and Skin Sensitization | ISO 10993 Part 10, 16CFR 1500.41, 16CFR 1500.3 | Meets |
| Resistance to Permeation (Chemotherapy Drugs) | ASTM D6978-05 | See specific breakthrough detection times below |
Breakthrough Detection Times (BDT) for Chemotherapy Drugs (Resistance to Permeation):
| Chemotherapy Drug | Average BDT |
|---|---|
| Fluorouracil | >240 min. |
| Etoposide (Toposar) | >240 min. |
| Cyclophosphamide (Cytoxan) | >240 min. |
| Carmustine | 2.03 min. |
| Thiotepa | 25.23 min. |
| Paclitaxel (Taxol) | >240 min. |
| Doxorubicin Hydrochloride | >240 min. |
| Dacarbazine (DTIC) | >240 min. |
| Cisplatin | >240 min. |
Important Note: The document explicitly states: "Please note that Carmustine and Thiotepa have extremely low permeation times of less than 30 minutes." This implies that while the device was tested against these drugs, their low BDTs are a critical factor for users to consider, and the labeling states "Do not use with Carmustine and Thiotepa."
2. Sample size 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 for each non-clinical test (e.g., how many gloves were tested for dimensions, physical properties, or permeation). It mentions the tests were performed by Syntex Healthcare Products Co., Ltd in China (the submitter's location), so the data likely originates from China. The tests are non-clinical and would be considered prospective for the purpose of the 510(k) submission.
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)
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
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
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
8. The sample size for the training set
9. How the ground truth for the training set was established
These questions are designed for AI/ML device evaluations. The presented document describes a traditional medical device (examination gloves) and its non-clinical testing. Therefore, these questions are not applicable to this submission. The "ground truth" for this device is determined by physical and chemical testing against established standards (e.g., ASTM standards for glove properties and permeation resistance). No AI/ML components are mentioned or evaluated in this 510(k) summary.
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(48 days)
A patient examination glove is a disposable device intended for medical purposes that is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste or environment.
A patient examination glove is disposable device intended for medical a purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Power-Free Nitrile Examination Gloves, Blue, 80 LZA, and meets all requirements of ASTM standard D-6319-00a (2005).
The provided text describes the 510(k) summary for the Hong Xin Rubber Products Co., Ltd. Powder Free Nitrile Examination Gloves, Blue. This document is a premarket notification for a Class I medical device, which is typically a low-risk device. For such devices, clinical studies and complex performance evaluations, as you've outlined, are generally not required. Instead, the focus is on demonstrating substantial equivalence to a predicate device through non-clinical testing and adherence to recognized standards.
Therefore, many of the requested sections (2-9) are not applicable to this type of submission.
Here's a breakdown based on the provided document:
Acceptance Criteria and Device Performance
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|
| ASTM D-6319-00a (2005) - Physical and Dimensions Testing (Inspection level S-2, AQL 4.0) | "All testing meets requirements for physical and dimensions testing conducted on gloves." |
| FDA 1000 ml. Water Fill Test (AQL 2.5, inspection level G-1) | "meeting these requirements." (Implies meeting pinhole requirements) |
| Primary Skin Irritation Testing | "results showing no primary skin irritant or sensitization reactions." |
| Skin Sensitization (allergic contact dermatitis) Testing | "results showing no primary skin irritant or sensitization reactions." |
| ASTM D-6124-06 - Residual Powder Test (for "powder-free" claim: ≤ 2 mg powder per glove) | "our gloves meet our “powder-free” claims (contain no more than 2 mg powder per glove)." |
| Biocompatibility Requirements (not explicitly detailed, but stated as met) | "meets biocompatibility requirements" |
| Applicable 21 CFR references (not explicitly detailed, but stated as met) | "conform fully to... applicable 21 CFR references" |
2. Sample size used for the test set and the data provenance
- Physical and Dimensions Testing (ASTM D-6319-00a): Inspection level S-2, AQL 4.0. The exact sample size is not stated but is determined by the AQL (Acceptable Quality Level) and inspection level for lot sizes as defined in the ASTM standard.
- FDA 1000 ml. Water Fill Test: Inspection level G-1, AQL 2.5. The exact sample size is not stated but is determined by the AQL and inspection level for lot sizes.
- Primary Skin Irritation and Skin Sensitization Testing: Not specified.
- Residual Powder Test (ASTM D-6124-06): Not specified.
- Data Provenance: Not explicitly stated, but assumed to be from internal testing conducted by Hong Xin Plastic Products Co., Ltd. within China. This is a retrospective analysis of manufacturing quality control data and specific biocompatibility tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The ground truth for this device is established by objective engineering and chemical standards, not expert clinical interpretation.
4. Adjudication method for the test set
Not applicable. The tests involve objective measurements and pass/fail criteria against established standards, not subjective 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 not an AI-powered diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI-powered diagnostic device.
7. The type of ground truth used
The ground truth used for this device is based on recognized industry standards (ASTM) and regulatory requirements (FDA pinhole test, 21 CFR). This includes:
- Defined specifications for physical properties (e.g., dimensions, tensile strength).
- Objective measurement criteria for defect levels (AQL for pinholes).
- Established procedures for biocompatibility (skin irritation and sensitization).
- Quantifiable limits for residual powder.
8. The sample size for the training set
Not applicable. This device does not use machine learning or AI, so there is no concept of a "training set." Performance is based on manufacturing quality control and specific material testing.
9. How the ground truth for the training set was established
Not applicable. There is no training set for this type of device.
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