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510(k) Data Aggregation
(509 days)
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(129 days)
BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES, POWDER FREE [PURPLE] TESTED FOR USE WITH CHEMOTHERAPY DRUGS is a disposable device intended for medical purpose worn on the examiners hand or finger to prevent contamination between patient and examiner.
The tested chemotherapy drugs and their breakthrough detection times are as follows :
| Test Chemotherapy Drug Name and Concentration | Minimum Breakthrough Detection Time |
|---|---|
| · Blenoxane (15mg/ml),(15,000 ppm) | >240 Minutes |
| · Busulfan(6mg/ml),(6,000 ppm) | >240 Minutes |
| · Carmustine (BCNU) (3.3mg/ml),(3,300 ppm) | 3.6 Minutes |
| · Cisplatin(1.0mg/ml), (1.000 ppm) | >240 Minutes |
| · Cyclophosphamide/Cytoxan(20mg/ml), (20,000 ppm) | >240 Minutes |
| · Cytarabine(100mg/ml), (100,000 ppm) | >240 Minutes |
| · Dacarbazine(DTIC) 10mg/ml, (10,000 ppm) | >240 Minutes |
| · Daunorubicin(5mg/ml), (5,000 ppm) | >240 Minutes |
| · Docetaxel(10mg/ml), (10,000 ppm) | >240 Minutes |
| · Doxorubicin HCL(2mg/ml),(2,000 ppm) | >240 Minutes |
| · Ellence (2mg/ml), (2,000 ppm) | >240 Minutes |
| · Etoposide /Toposar (20mg/ml), (20,000 ppm) | >240 Minutes |
| · Fludarabine (25mg/ml), (25,000 ppm) | >240 Minutes |
| · Fluorouracil(50mg/ml), (50,000 ppm) | >240 Minutes |
| · Gemcitabine (38mg/ml), (38,000 ppm) | >240 Minutes |
| · Idarubicin(1.0mg/ml), (1,000 ppm) | >240 Minutes |
| · Ifosfamide (50mg/ml), (50,000 ppm) | >240 Minutes |
| · Irinotecan(20mg/ml), (20,000 ppm) | >240 Minutes |
| · Mechlorethamine HCI(1.0mg/ml), (1,000 ppm) | >240 Minutes |
| · Melphalan(5mg/ml), (5,000 ppm) | >240 Minutes |
| · Methotrexate(25mg/ml),(25,000 ppm) | >240 Minutes |
| · Mitomycin C(0.5 mg/ml), (500 ppm) | >240 Minutes |
| · Mitoxantrone(2mg/ml),(2,000 ppm) | >240 Minutes |
| · Paclitaxel(6.0mg/ml),(6,000 ppm) | >240 Minutes |
| · Paraplatin (10mg/ml),(10,000 ppm) | >240 Minutes |
| · Rituximab(10mg/ml),(10,000 ppm) | >240 Minutes |
| · Thiotepa (10mg/ml),(10,000 ppm) | 15.9 Minutes |
| · Trisenox(0.1mg/ml), (100 ppm) | >240 Minutes |
| · Vincristine Sulfate(1.0mg/ml),(1,000 ppm) | >240 Minutes |
Please note that Carmustine and Thiotepa have extremely low permeation times of 3,6 minutes, respectively
WARNING: Do Not Use With : Carmustine, ThioTEPA
The subject device in this 510(k) Notification is a Purple Nitrile Examination glove tested for use with Chemotherapy drugs.
The subject device is a patient examination glove made from nitrile compound, Purple color, powder free and non-sterile (as per 21 CFR 880.6250, class I).
The principle 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 D6319-10, Standard specification for Nitrile Examination Gloves.
This device also complies with requirements for Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs as per ASTM D6978-05.
The provided document pertains to a 510(k) premarket notification for "BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES, POWDER FREE [PURPLE] TESTED FOR USE WITH CHEMOTHERAPY DRUGS." This is a Class I medical device, and the submission aims to demonstrate substantial equivalence to a legally marketed predicate device (K992162 Safeskin Purple Powder-Free Nitrile Examination Gloves for Use with Chemotherapeutic Drugs Labeling Claim).
The document does not describe an AI/ML-based device or a study involving human readers and AI assistance for medical image analysis. Instead, it details the physical and chemical properties of examination gloves, their resistance to chemotherapy drugs, and their biocompatibility, as per standard testing protocols for such devices.
Therefore, many of the requested elements for an AI/ML device study (e.g., sample size for AI test and training sets, number of experts for ground truth, MRMC studies, standalone algorithm performance, AI effect size) are not applicable to this document.
However, I can extract the acceptance criteria and performance data relevant to this specific device (examination gloves):
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are generally based on meeting established ASTM (American Society for Testing and Materials) and ISO (International Organization for Standardization) standards as outlined in the document, and demonstrating performance comparable to the predicate device. The reported performance indicates compliance with these standards.
| Device Characteristics | Test Standard | Acceptance Criteria (General) | Reported Device Performance |
|---|---|---|---|
| Product: Nitrile Examination Gloves, Powder Free (Purple) Tested For Use with Chemotherapy Drugs | |||
| Primary Function: Barrier protection to prevent contamination between patient and examiner. Tested for resistance to permeation by chemotherapy drugs. | |||
| Chemical Permeation: | ASTM D6978-05 (Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs) | Minimum breakthrough detection times for various chemotherapy drugs, typically >240 minutes for most tested drugs. Special note for drugs with low permeation times. | Met or exceeded >240 minutes for most tested drugs. Carmustine (3.3mg/ml): 3.6 minutes; Thiotepa (10mg/ml): 15.9 minutes. (These values are declared and warned against, indicating they meet the disclosure requirement but are below the general >240 min goal, hence the warning). The device meets the requirement by truthfully reporting its performance for each chemical. |
| Physical Attributes (General): | ASTM D6319-10 (Standard Specification for Nitrile Examination Gloves) | Compliance with all requirements in ASTM D6319-10, including dimensions, physical properties (tensile strength, elongation). | Complies with ASTM D6319-10 both before and after accelerated aging. All sizes comply with length, width, and thickness dimensions. |
| Freedom from Holes: | ASTM D6319-10 by D5151-06 | Must meet specified AQL (Acceptable Quality Level) for freedom from holes. | Pass (Implies meeting or exceeding the AQL). |
| Powder Free Designation: | ASTM D6319-10 by D6124-06 | Less than 2.0 mg powder per glove. | Less than 2.0 mg per glove; Pass. |
| Biocompatibility: | ISO 10993-10:2010 (Reapproved 2014) | Not a skin irritant; Not a skin sensitizer. | Under conditions of the test, not a skin irritant; Under conditions of the test, not a skin sensitizer. |
| ISO 10993-11:2006 (Reapproved 2010) | Does not cause systemic toxicity. | Under conditions of the test, does not cause systemic toxicity. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not explicitly state the specific number of gloves (sample size) for each particular test. However, it references standards like ASTM D6319-10 and ISO 2859 (Sampling Procedures and Tables for Inspection by Attributes), which would dictate the appropriate sample sizes for the various tests (e.g., tensile strength, dimensions, pinholes, chemotherapy drug permeation). For example, ASTM D6978-05 for chemotherapy drug permeation typically involves testing a specified number of samples (often 3 replicates) per drug, which are then averaged or used to determine breakthrough time.
- Data Provenance: The testing was "non-clinical performance data" (Section 7). The manufacturing company, Brightway Holdings Sdn. Bhd., is located in Malaysia (Section 3). The testing was conducted according to international standards (ASTM, ISO), meaning the data provenance is from laboratory tests, not from human retrospective or prospective clinical data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Not Applicable. This is a physical device being tested against established ASTM and ISO standards in a laboratory setting. There is no concept of "ground truth" derived from human expert interpretation (like medical images) for this type of product. The "ground truth" is defined by the objective measurements and protocols outlined in the referenced standards.
4. Adjudication Method for the Test Set
- Not Applicable. As this involves laboratory testing against objective standards (e.g., measuring breakthrough time, tensile strength), there is no human adjudication process involved in establishing "ground truth" or test results in the way it would be for interpreting medical images. The measurements are taken by lab technicians and reported against the standard's pass/fail criteria or quantitative thresholds.
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 is for examination gloves, not an AI/ML device. Therefore, no MRMC study with human readers or AI assistance was conducted.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is for examination gloves, not an AI/ML algorithm.
7. The Type of Ground Truth Used
- Ground Truth: The "ground truth" for this device is defined by objective, standardized measurements and laboratory test results as per recognized ASTM and ISO international standards.
- For chemotherapy drug permeation: Breakthrough time measured according to ASTM D6978-05.
- For physical properties (tensile strength, elongation, dimensions, holes): Measured according to ASTM D6319-10 and its referenced sub-standards (e.g., ASTM D412, D5151).
- For biocompatibility: Biological responses (irritation, sensitization, systemic toxicity) measured according to ISO 10993-10 and ISO 10993-11.
8. The Sample Size for the Training Set
- Not Applicable. As this is not an AI/ML device, there are no training sets in the context of machine learning. The "training" for manufacturing occurs through process control and quality management systems to ensure consistent product performance.
9. How the Ground Truth for the Training Set was Established
- Not Applicable. No AI/ML training set is involved.
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(50 days)
Brightway TM Brand Nitrile Examination Gloves, Powder Free, Non - Sterile (Grey Color) is a patient examination glove is a disposable device intended for medical purpose worn on the examiners hand or finger to prevent contamination between patient and examiner.
Brightway ™ Brand Nitrile Examination Gloves, Powder Free, Non-Sterile. (Grey Color)
This looks like a 510(k) clearance letter from the FDA for medical gloves, and as such, the concept of "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of an AI/ML device isn't directly applicable here.
This document pertains to a Class I medical device (patient examination gloves), which are largely regulated based on established standards for manufacturing, materials, and basic performance rather than clinical efficacy studies and "acceptance criteria" of an AI algorithm.
Therefore, many of the specific questions you've asked regarding AI/ML studies (like effect size of AI assistance, sample size for training/test sets, ground truth methodology, and expert qualifications for adjudication) do not apply to this type of device.
If you are looking for an example of a device with such details, this document is not the right source.
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(114 days)
BRIGHTWAY™ Brand Nitrile Examination Glove ( Powder Free, Chlorinated, Black Color ) is a disposable patient examination glove which is worn on the hand of healthcare and similar personnel to prevent contamination between patient and examiner.
BRIGHTWAY™ Brand Nitrile Examination Gloves (Powder Free, Chlorinated, Black Colour)
Here's an analysis of the provided text regarding acceptance criteria and study information:
The provided text describes two distinct medical devices and their respective 510(k) submissions. I will analyze the information for each separately as they don't seem to be related.
Device 1: SafeTip Safety Syringe (KOGO402)
This document mentions testing in a very general way and does not provide specific acceptance criteria or detailed study information. It states:
"The Devon SafeTip Safety Syringe has been shown to meet internationally recognized standards for syringe performance and labeling characteristics. Simulated clinical use testing has demonstrated the performance of the SafeTip syringe and reliability of the safety feature in accordance with the FDA Guidance: Medical Devices with Sharps Injury Prevention Features: August 9, 2005."
From this, we can infer that the device was tested against "internationally recognized standards for syringe performance" and the "FDA Guidance: Medical Devices with Sharps Injury Prevention Features: August 9, 2005." However, the specific metrics, thresholds, or details of the study itself are not present.
Given the information provided, it's impossible to fill out the requested table and answer many of the specific questions.
Device 2: BRIGHTWAY™ Brand Nitrile Examination Gloves (K060402)
This document is a 510(k) clearance letter for examination gloves. It does not contain any information about specific acceptance criteria or performance studies of the device. It primarily details the regulatory clearance process and refers to general controls. The "Indications for Use" section simply describes the intended use of the gloves.
Therefore, for this device, it's also impossible to fill out the requested table and answer the specific questions about acceptance criteria and studies.
Summary of Missing Information for BOTH Devices:
The provided texts are regulatory submission documents (or summaries thereof) that indicate a device has undergone testing and met certain standards, but they do not include the specific details of those tests, acceptance criteria, or study methodologies. To answer your questions fully, you would need access to the actual test reports or detailed study summaries that would have been part of the full 510(k) submission.
Attempting to fill what little can be inferred from the "SafeTip Safety Syringe" document, with heavy caveats:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Metric (Inferred) | Acceptance Threshold (Inferred) | Reported Device Performance (Inferred) |
|---|---|---|---|
| Syringe Performance | Not specified (e.g., fluid delivery accuracy, plunger force) | Not specified (e.g., +/- X%, < Y N) | "Meets internationally recognized standards for syringe performance" |
| Safety Feature Reliability | Prevention of accidental needle sticks post-injection | 100% or very high percentage of successful sheath deployment | "Demonstrated... reliability of the safety feature" |
| Conformity to Guidance | Adherence to FDA Guidance: Medical Devices with Sharps Injury Prevention Features: August 9, 2005 | Full compliance | "In accordance with the FDA Guidance" |
2. Sample size used for the test set and the data provenance
- Sample size: Not specified.
- Data provenance: "Simulated clinical use testing" is mentioned, implying controlled laboratory or simulated environment. Country of origin not specified, but the applicant (Devon Safety Products) is based in the USA.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not specified. Testing likely involved engineers and technicians, not medical experts establishing ground truth in the traditional sense for diagnostic AI.
4. Adjudication method for the test set
- Not applicable as the study involves functional performance testing, not expert interpretation.
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 performance study, not an AI diagnostic study involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This is a physical device performance study.
7. The type of ground truth used
- The "ground truth" would be the objective measurement of the device's functional performance against established engineering and safety standards (e.g., successful deployment of the safety sheath, accurate fluid delivery, material strength, etc.).
8. The sample size for the training set
- Not applicable. This is a physical device, and the concept of a "training set" is not relevant in the AI/machine learning sense.
9. How the ground truth for the training set was established
- Not applicable for the same reason as above.
Conclusion for both devices: The provided text is insufficient to answer most of your detailed questions regarding acceptance criteria and study specifics. This information is typically found in detailed test reports and clinical study summaries, not typically in the brief 510(k) summary or clearance letters themselves.
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(54 days)
BRIGHTWAY™ Brand Latex Examination Glove ( Powder Free, Black Color ) containing 50 µgm or less of water extractable protein per gram is a disposable patient examination glove which is worn on the hand of healthcare and similar personnel to prevent contamination between patient and examiner.
Not Found
This document is a 510(k) premarket notification letter from the FDA regarding "BRIGHTWAY™ Brand Latex Examination Gloves (Power Free, Black Color) Containing 50 ug or Less of water Extractable Protein Per Gram". It details the FDA's determination of substantial equivalence to legally marketed predicate devices.
However, the provided text does not contain information about acceptance criteria, device performance results, sample sizes for testing or training, expert ground truth establishment, or any details about a study and its methodology as requested in your prompt. The document is an administrative approval letter, not a scientific study report.
Therefore, I cannot populate the table or answer the subsequent questions based on the information provided in the input.
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(59 days)
Not Found
Not Found
The provided document is a 510(k) premarket notification letter from the FDA regarding "Brightway Brand Latex Examination Gloves." This letter does not contain any information about acceptance criteria or a study proving that a device meets such criteria, as it pertains to medical device software or AI/ML-based devices.
The document is an approval for a physical medical device (gloves) and outlines regulatory compliance for registration, labeling, and manufacturing practices, not performance metrics for an AI system.
Therefore, I cannot provide the requested information based on the input text.
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(59 days)
BRIGHTWAY™ Brand Latex Examination Gloves (Powdered, sterile) containing 150 ugm or less of water extractable protein per gram is a disposable patient examination glove made of Natural Rubber which is worn on the hand of healthcare and similar personnel to prevent contamination from patient and examiner.
BRIGHTWAY™ Brand Latex Examination Gloves (Powdered, Sterile) Containing 150 ugm or less of water extractable protein per gram.
The provided document is a 510(k) premarket notification letter from the FDA for "Brightway Brand Latex Examination Gloves (Powdered, Sterile) Containing 150 ugm or Less of water Extractable Protein Per Gram." This type of document is for a medical device that does not involve software or an AI algorithm, and therefore, the requested information about acceptance criteria for an AI device, study design, sample sizes, expert ground truth, adjudication methods, MRMC studies, or standalone performance is not applicable to this document.
The document primarily states that the device is "substantially equivalent" to legally marketed predicate devices. It discusses regulatory classifications, general controls, and compliance requirements for the physical medical device (gloves). It does not contain any performance data, clinical study results, or information related to acceptance criteria for an artificial intelligence or machine learning model.
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(18 days)
Brightway TM Brand Colored Powder Free Nitrile Examination Gloves (Orange) ia a disposable patient examination glove which is worn on the hand of healthcare and similar personnel to prevent contamination from patient and examiner.
Brightway TM Brand Colored Powder Free Nitrile Examination Gloves (Orange)
The provided text is a 510(k) premarket notification letter from the FDA to Brightway Holdings Sdn. Bhd. for "Brightway Brand Colored Powder Free Nitrile Examination Gloves, Orange". This document approves the device for market based on substantial equivalence to a predicate device.
It does NOT contain the type of acceptance criteria, study details, or performance data typically found for AI/ML-based medical devices. The letter explicitly states that the FDA has determined the device is "substantially equivalent" to legally marketed predicate devices, meaning it doesn't require a new premarket approval application (PMA) or extensive clinical trials as would be the case for novel AI.
Therefore, I cannot provide the requested information about acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, or ground truth establishment. This information is simply not present in the provided text.
The document discusses regulatory classification (Class I), general controls, and compliance requirements, but not the technical performance metrics of the gloves themselves.
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(35 days)
examination glove which is worn on the hand of healthcare and similar personnel to prevent contamination between patient and examiner and also to protect the examiner's hands from being affected by the chemicals used in therapy. This glove is to be used in a Non Sterile environment.
BRIGHTWAY TM Brand Powder Free Latex Examination Gloves Blue Color, Non-Sterile ( containing 50 ugm or less of water extractable protein per gram.) (tested for use with Chemotherapy Drugs, Carmustine, Fluorouracil, Methotrexate)
The provided document is a 510(k) premarket notification letter from the FDA for medical examination gloves and does not contain information about acceptance criteria or a study proving a device meets those criteria, particularly for an AI/algorithm-based medical device.
Therefore, I cannot extract any of the requested information from this document. The document primarily focuses on the regulatory approval for a physical medical device (latex examination gloves) and not on a digital device or algorithm with performance metrics.
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(76 days)
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