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510(k) Data Aggregation
(156 days)
The Nitrile Powder Free Examination Glove (Blue) with Low Dermatitis Potential Claim is a disposable device intended for Medical purpose that is worn on the examiner's hands or finger to prevent contamination patient and examiner. In addition these gloves was tested for use with Chemotherapy drugs in accordance with ASTM D6978-05 standards, Practice for assessment of medical glove to Permeation by Chemotherapy Drugs.
The subject device in this 510(k) Notification is Blue Nitrile Examination gloves, with Low Dermatitis Potential Claim and tested for use with Chemotherapy drugs. The subject device is a patient examination glove made from nitrile compound, Blue color, powder free and nonsterile (Per 21 CFR 880.6250, class I). The device meets all the specifications in ASTM D6319-10, ASTM D5151-06, ASTM D6124-06, and ASTM D6978-05 and Modified Draize 95 test.
The provided document describes the safety and performance characteristics of a Powder Free Nitrile Examination Glove (Blue) with Low Dermatitis Potential Claim and with tested for use with Chemotherapy Drugs Claims (K181066), rather than an AI/ML powered medical device. Therefore, much of the requested information (e.g., AI/ML specific acceptance criteria, sample sizes for test/training sets, ground truth establishment methods, MRMC studies, standalone performance studies) is not applicable or available within this document.
However, I can extract and present the available information regarding the glove's acceptance criteria and the studies conducted to demonstrate its performance against those criteria.
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristics | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Product Code | LZA, LZC | LZA, LZC |
| Intended Use | A powder free patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. The device is for over-the-counter use. | A powder free patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. The device is for over-the-counter use. |
| Material Use | Nitrile compound | Nitrile compound |
| Color | Blue | Blue |
| Sterility | Non sterile | Non sterile |
| Single Use | Single used | Single used |
| Dimensions | Overall Length (mm): Min 230mmWidth (± 5mm): Size S = 85mm, Size M = 95mm, Size L = 105mm, Size XL = 115mmThickness at Palm (mm): Min; 0.05 mmThickness at Finger Tip (mm): Min 0.05 mm | Min 230mm (for length, width, and thickness values are specific to the given sizes and meet min 0.05mm for Palm and Finger Tip). |
| Physical Properties | Before Ageing:Tensile Strength (MPa) = 14minUltimate Elongation (%) = 500minAfter Aging at 70ºC for 168 hrs @ 100℃ for 22 hrs:Tensile Strength (MPa) = 14minUltimate Elongation (%) = 400min | Before aging:Tensile strength: Min 14 MpaUltimate Elongation: Min 500%After Aging:Tensile strength: Min 14 MpaUltimate Elongation: Min 400% |
| Freedom from pinholes | AQL 2.5, Inspection Level G-1 | Meets ASTM D5151-06 (which specifies AQL 2.5, Inspection Level G-1) |
| Residual Powder | ≤ 2.0 mg/pc | ≤ 2.0 mg/pc |
| Biological Evaluation on Medical Device - Primary Skin Irritation Test | Not explicitly stated as a numerical value, but implied to be non-irritant. | Under the conditions of this study, the test article was a non-irritant. |
| Biological Evaluation on Medical Device - Dermal Sensitization Assay | Not explicitly stated as a numerical value, but implied to be non-sensitizer. | Under the conditions of this study, the test article was a non-sensitizer. |
| ISO 10993-5:2009 Biological Evaluation of Medical Device - Part 5: Test for In Vitro Cytotoxicity | Not explicitly stated as a numerical value, but implied to be non-cytotoxic. | Under the conditions of this study, the test article was not cytotoxic. |
| Resistance against Chemotherapy Drugs (Minimum Breakthrough Detection time in minutes) | ||
| 1) Carmustine (BCNU)(3.3 mg/ml) | 12.9 min | |
| 2) Cisplatin (1.0 mg/ml) | No breakthrough up to 240 min | |
| 3) Cyclophosphamide (Cytoxan)(20 mg/ml) | No breakthrough up to 240 min | |
| 4) Dacarbazine (DTIC) (10.0 mg/ml) | No breakthrough up to 240 min | |
| 5) Doxorubicin Hydrochloride (2.0 mg/ml) | No breakthrough up to 240 min | |
| 6) Etoposide (Toposar)(20.0 mg/ml) | No breakthrough up to 240 min | |
| 7) Fluorouracil (50.0 mg/ml) | No breakthrough up to 240 min | |
| 8) Paclitaxel (Taxol)(6.0 mg/ml) | No breakthrough up to 240 min | |
| 9) Thiotepa (10.0 mg/ml) | 24.7 min | |
| Low Dermatitis Potential Claim | No clinical evidence of residual chemical additives that may induce Type IV allergy in human subjects | No Clinical evidence presence of residual chemical additives that may induce Type IV allergy in human subject |
2. Sample Sizes Used for the Test Set and Data Provenance
- Physical and Chemical Tests: The document refers to compliance with various ASTM standards (D6319-10, D5151-06, D6124-06, D6978-05). These standards prescribe specific sampling plans and test methods. The exact sample sizes used for each of these physical and chemical tests are not explicitly stated in this summary. The data provenance would be from laboratory testing according to these standards.
- Biocompatibility/Low Dermatitis Potential Claim:
- Sample Size: A total of 205 human subjects were tested for the Modified Draize-95 test. This involved an initial population of 30, with a further number added to reach 205.
- Data Provenance: The study was a prospective human subject test conducted to evaluate the potential for irritation or sensitization. The document states the subjects "reasonably reflect the general user population in the US." The country of origin of the data is not explicitly stated, but the mention of "human subjects...in the US" could imply the study was conducted there, or at least designed to reflect a US population's response.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- For the physical and chemical tests (e.g., tensile strength, pinholes, chemotherapy drug permeation), the "ground truth" is established by the direct measurement or observation of the glove's performance against the objective criteria set by the ASTM standards. No human consensus "experts" are typically involved in establishing this type of ground truth beyond the trained personnel performing the tests according to the standard operating procedures.
- For the Low Dermatitis Potential Claim, the "ground truth" was established by the clinical observations of the 205 human subjects during the Modified Draize-95 test. The document states, "The study completed on 205 non sensitized adult human subjects... gave all negative results. There was no clinical evidence of the presence of residual chemical additives that may induce Type IV allergy..." This implies clinical evaluation by medical professionals, but the number and specific qualifications of these experts are not provided in the document.
4. Adjudication Method for the Test Set
- For the physical and chemical tests, adjudication is based on whether the measured values meet the specified criteria in the ASTM standards.
- For the Low Dermatitis Potential Claim via the Modified Draize-95 test, the outcome ("all negative results," "no clinical evidence") suggests a direct observation and interpretation by clinical evaluators rather than a formal multi-reader adjudication process like 2+1 or 3+1. The methodology would follow the specified FDA guidance document referenced.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
- Not Applicable. This document describes a medical glove, not an AI/ML powered device. Therefore, no MRMC study involving human readers with or without AI assistance was conducted or reported.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not Applicable. This document describes a medical glove, not an AI/ML powered device. Therefore, no standalone algorithm performance study was conducted or reported.
7. The Type of Ground Truth Used
- Objective Measurement/Standard Compliance: For physical properties (dimensions, tensile strength, elongation, pinholes, residual powder) and chemotherapy drug resistance, the ground truth is based on direct laboratory measurements and adherence to established ASTM standards.
- Clinical Observation: For the biocompatibility claims (primary skin irritation, dermal sensitization, cytotoxicity) and the low dermatitis potential claim, the ground truth is based on clinical observations and laboratory assays as per ISO 10993-10:2010, ISO10993-5, 16 CFR Part 1500.41, and the Modified Draize-95 test results on human subjects.
8. The Sample Size for the Training Set
- Not Applicable. This is not an AI/ML device, so there is no training set in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. As there is no AI/ML component, there is no training set or ground truth establishment for such a set.
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(111 days)
The Nitrile Powder Free Examination Glove (Blue) with Low Dermatitis Potential Claim is a disposable device intended for Medical purpose that is worn on the examiner's hands or finger to prevent contamination patient and examiner In addition these gloves was tested for use with Chemotherapy drugs in accordance with ASTM D6978-05 standards, Practice for assessment of medical glove to Permeation by chemotherapy Drugs.
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 standards ,Practice for assessment of Medical Glove to Permeation by chemotherapy Drugs . It is for overthe-counter use.
The subject device in this 510(k) Notification is Blue Nitrile Examination gloves, with claiming, this product contain Low Dermatitis Potential Claim and tested for use with Chemotherapy drugs. The subject device is a patient examination glove made from nitrile compound, Blue color, powder free and non sterile (Per 21 CFR 880.6250, class I). The device meets all the specifications in ASTM D6319-10, Standard specification for Nitrile Examination Gloves.
This document outlines the acceptance criteria and supporting studies for the "Powder Free Nitrile Examination Glove (Blue) With Low Dermatitis Potential Claim and with tested for Use with Chemotherapy Drugs" (K152542).
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Acceptance Criteria | Reported Device Performance (K152542) |
|---|---|---|
| Product Code | LZA, LZC | LZA, LZC |
| Intended Use | A powder-free patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. The device is for over-the-counter use. | Meets criteria. Additionally, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 standards, Practice for assessment of medical glove to Permeation by chemotherapy Drugs. |
| Material Use | Nitrile compound | Nitrile compound |
| Color | Blue | Blue |
| Sterility/Single Used | Non sterile, Single used | Non sterile, Single used |
| Dimensions (Overall Length, Width, Thickness) | Overall Length (mm): Min 270mmWidth (±5mm): Size S = 85mm, Size M = 95mm, Size L = 105mm, Size XL = 115mmThickness at Palm (mm): Min; 0.10 mmThickness at Finger Tip (mm): Min 0.10 mm | Meets ASTM D6319-10 (Standard Specification for Nitrile Examination Gloves) |
| Biological Evaluation - Primary Skin Irritation | Test article should be a non-irritant. | Under the conditions of this study, the test article was a non-irritant. |
| Physical Properties (Before Ageing) | Tensile Strength (MPa): >= 14minUltimate Elongation (%): >= 500min | Meets ASTM D6319-10 |
| Physical Properties (After Aging) | After Aging at 70°C for 168 hrs @ 100°C for 22 hrs:Tensile Strength (MPa): >= 14minUltimate Elongation (%): >= 400min | Meets ASTM D6319-10 |
| Biological Evaluation - Dermal Sensitization Assay | Test article should be a non-sensitizer. | Under the conditions of this study, the test article was a non-sensitizer. |
| Resistance against Chemotherapy Drugs | Minimum Breakthrough Detection time in minutes (0.01 µg/cm²/minute) based on ASTM D6978-05 for specified drugs. | Carmustine (BCNU) (3.3mg/ml): 20.1 minutesCyclophosphamide (20mg/ml): > 240 minutesCisplatin (1.0mg/ml): > 240 minutesDoxorubicin Hydrochloride (2 mg/ml): > 240 minutesEtoposide (20mg/ml): > 240 minutesFluorouracil (50mg/ml): > 240 minutesMethotrexate (25mg/ml): > 240 minutesPaclitaxel (6mg/ml): > 240 minutesThiotepa (10mg/ml): 50.6 minutes |
| Freedom from Pinholes | AQL 2.5, Inspection Level G-1 | Meets ASTM D5151-06 |
| Residual Powder | < 2.0 mg/pc | Meets ASTM D6124-06 |
| Low Dermatitis Potential Claim | No clinical evidence of residual chemical additives that may induce Type IV allergy in human subjects (based on Modified Draize 95 test). | No clinical evidence presence of residual chemical additives that may induce Type IV allergy in human subject. |
2. Sample Size Used for the Test Set and Data Provenance
The document details testing for various attributes, with specific sample sizes and testing methods mentioned.
-
Mechanical Properties (Dimensions, Physical Properties, Freedom from Pin-holes, Residual Powder): The testing was conducted according to ASTM D6319-10, ASTM D5151-06, and ASTM D6124-06. These standards typically specify sampling plans (e.g., AQL levels for pinholes) which define the sample sizes. The document states "Gloves meet all the specification listed in ASTM D 6319-10" and "Meets ASTM D5151-06" and "Meets ASTM D6124-06", indicating adherence to these sampling requirements. Specific numerical sample sizes for each test are not explicitly provided in the summary, but are implied by reference to the ASTM standards.
-
Resistance Against Chemotherapy Drugs: Tested in accordance with ASTM D6978-05. The specific sample size used for this test is not explicitly stated in the provided text.
-
Low Dermatitis Potential Claim (Skin Sensitization):
- Sample Size: Initial stage with 30 human subjects, followed by an additional number of subjects to reach a total of a minimum of 205 individuals.
- Data Provenance: The study was conducted on "non sensitized adult human subjects, who reasonably reflect the general user population in the US." This implies the data is prospective and representative of the US population, although the study itself was likely conducted by the manufacturer (Riverstone Resources Sdn. Bhd. in Malaysia) or a contract research organization.
-
Primary Skin Irritation: The specific sample size for this test is not explicitly stated but is also an in-vivo biological evaluation performed under ISO 10993-10:2010.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- For physical and chemical properties (e.g., dimensions, tensile strength, chemotherapy drug permeation, pinholes, residual powder): The ground truth is established by objective, standardized laboratory tests according to recognized ASTM and ISO standards. These do not typically involve human "experts" in the way clinical studies do. The "ground truth" is the quantitative measurement or qualitative assessment (e.g., pass/fail) determined by the test method.
- For Low Dermatitis Potential Claim (Modified Draize 95 test): This is a human subject study. The nature of the "ground truth" is the observed skin reaction (or lack thereof) in the human subjects. The qualification of individuals assessing these reactions (e.g., dermatologists) is not specified in the document but would typically involve trained medical professionals or researchers.
4. Adjudication Method for the Test Set
- For physical and chemical properties: Adjudication is not applicable in the traditional sense. The results are objective measurements against predefined criteria.
- For Low Dermatitis Potential Claim (Modified Draize 95 test): The document states that "The study completed on 205 non sensitized adult human subjects...gave all negative results. There was no clinical evidence of the presence of residual chemical additives..." This implies a direct observation and interpretation by the study's clinical staff. No specific adjudication method like "2+1" or "3+1" is mentioned for conflicting expert opinions, as the result was consistently negative for all subjects.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No, an MRMC comparative effectiveness study was not done. This device is a medical glove, and the studies described are performance and biocompatibility assessments, not diagnostic imaging or clinical decision support tools that would typically involve human readers or AI assistance in the way an MRMC study is designed.
6. If a Standalone (algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a physical product (a glove), not an algorithm or a software device. The concept of "standalone performance" for an algorithm without human involvement does not apply here. The performance is the inherent performance of the glove itself.
7. The Type of Ground Truth Used
- Physical/Chemical Properties: Standardized measurements and assessments from laboratory testing against established specifications (e.g., ASTM standards). This is objective laboratory data.
- Chemotherapy Drug Permeation: Breakthrough detection time measured in accordance with ASTM D6978-05. This is objective laboratory data.
- Primary Skin Irritation and Dermal Sensitization: In-vivo biological response observed in animal studies (for general biocompatibility, although human studies were done for sensitization). For the Low Dermatitis Potential Claim, the ground truth is the clinical outcome (presence or absence of irritation/sensitization) observed in human subjects.
8. The Sample Size for the Training Set
- Not applicable. This document describes the performance of a manufactured medical device (glove), not an AI or machine learning model. Therefore, there is no "training set" in the context of algorithm development. The "training" for such a product would involve manufacturing process controls and quality assurance, which are not detailed as a "training set" in this context.
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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(98 days)
This glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. This glove has been tested for use with specific chemotherapy drugs listed below.
Powder Free Nitrile Examination Glove (Blue). This Product Does Not Contain Thiuram, and/or Carbamate and/or Thiazole. Low Dermatitis Potential Tested For Use With Chemotherapy Drugs.
The provided text describes a 510(k) premarket notification for a medical device: "Powder Free Nitrile Examination Glove (Blue), This Product Does Not Contain Thiuram, and/or Carbamate and/or Thiazole, Low Dermatitis Potential, Tested for Use With Chemotherapy Drugs."
This document is a regulatory clearance letter and does not contain the acceptance criteria or a study description in the format of a typical scientific or clinical study. It refers to the device's substantial equivalence to legally marketed predicate devices and mentions that the glove "has been tested for use with specific chemotherapy drugs."
However, based on the information provided, we can infer some details related to acceptance criteria and performance for the chemotherapy drug permeation testing, which is a specific claim for this device.
Here's an attempt to structure the available information per your request, recognizing the limitations of the source document:
1. Table of Acceptance Criteria and Reported Device Performance (Chemotherapy Drug Permeation)
The "Indications for Use" section lists specific chemotherapy drugs and their "Average Breakthrough Detection Time in Minutes." While not explicitly stated as "acceptance criteria," the listed times for each drug represent the performance achieved, and for most, a ">240 minute" breakthrough time is implied as a desirable (and likely passed) threshold for safe use. The specific values obtained for each drug would be the "reported device performance."
| Chemotherapy Drug | Acceptance Criteria (Implied) | Reported Device Performance (Average Breakthrough Detection Time in Minutes) |
|---|---|---|
| Dacarbazine (DTIC) | >240 minutes | >240 |
| Cyclophosphamide (Cytoxan) | Sufficiently High (e.g., >60 minutes for some standards) | 69.59 |
| Doxorubicin Hydrochloride | >240 minutes | >240 |
| 5-Fluorouracil | >240 minutes | >240 |
| Cisplatin | >240 minutes | >240 |
| Etoposide | >240 minutes | >240 |
| Paclitaxel (Taxol) | >240 minutes | >240 |
Note: The document explicitly states "Warning: Do Not Use With Thiotepa or Carmustine," indicating that the device did not meet acceptance criteria for these specific drugs or was not tested for them in a way that would deem it safe.
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified in this regulatory letter. For permeation testing, this typically involves multiple glove samples tested per drug.
- Data Provenance: Not explicitly stated (e.g., country of origin). The applicant, Smart Glove Corporation Sdn. Bhd., is based in MALAYSIA. It's common for testing to be conducted in a laboratory setting, which could be in various locations. The data is retrospective relative to the submission date of the 510(k).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. This is a physical device performance test (chemotherapy drug permeation), not a diagnostic or interpretative study requiring human experts for ground truth establishment. The "ground truth" is determined by laboratory testing methods (e.g., spectrophotometry or chromatography to detect drug breakthrough).
4. Adjudication method for the test set
- Not Applicable. As this is a laboratory performance test, there isn't a need for expert adjudication in the same way there would be for a clinical diagnostic study. Measurements are typically objective based on standardized test methods.
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 (glove) and not an AI-powered diagnostic or interpretive tool. Therefore, MRMC studies involving human readers and AI assistance are not relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a physical device. Standalone algorithm performance refers to AI systems without human intervention, which is not relevant here.
7. The type of ground truth used
- Laboratory Testing / Standardized Test Methods: The "ground truth" for the chemotherapy drug permeation testing would be the objective measurement of drug breakthrough time through the glove material. This is established by specific, standardized laboratory protocols, likely following methods like ASTM D6978 (Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs).
8. The sample size for the training set
- Not Applicable. There is no "training set" in the context of this physical device performance testing. Training sets are relevant for machine learning or AI models.
9. How the ground truth for the training set was established
- Not Applicable. As there is no training set, this question is not applicable.
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(60 days)
This glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. This glove has been tested for use with specific chemotherapy drugs.
Powder Free Nitrile Examination Glove (Blue). This Product Does Not Contain Thiuram, and/or Carbamate and/or Thiazole. Tested For Use With Chemotherapy Drugs.
This document is a 510(k) premarket notification letter for "Powder Free Nitrile Examination Gloves (Blue)". It describes the device and its intended use, but it does not contain any information about acceptance criteria or a study proving the device meets those criteria from an AI/algorithm perspective.
The device in question is a medical glove, which is a physical product, not an AI or algorithm. Therefore, the questions posed regarding AI performance metrics, sample sizes for test sets, expert ground truth, adjudication methods, MRMC studies, standalone performance, training sets, and ground truth establishment for training sets are not applicable to the content of this document.
The letter states that the FDA found the device "substantially equivalent" to legally marketed predicate devices, meaning it met the requirements for this type of medical device at the time of review (October 2008), but it doesn't detail performance studies in the way an AI/algorithm development report would.
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(89 days)
The glove is disposable and intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
Powder Free Nitrile Examination Glove (Blue) (This product does not contain Thiuram, and/or Carbamate and/or Thiazole)
This document is a 510(k) clearance letter from the FDA for a medical device, specifically "Powder Free Nitrile Examination Glove (Blue)". It does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML medical device.
The information requested in your prompt (e.g., sample size for test set, number of experts, adjudication method, MRMC studies, standalone performance, ground truth types for training and test sets) is typical for AI/ML device submissions to the FDA. However, this document pertains to a physical medical device (examination gloves) and therefore, the content does not align with the questions you've asked about AI/ML device performance.
Therefore, I cannot extract the requested information from the provided text. The document is about regulatory clearance for a traditional medical product based on substantial equivalence to existing products, not about the performance evaluation of a software algorithm.
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