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510(k) Data Aggregation
(120 days)
Powder Free Blue Nitrile Examination Gloves are disposable device intended for medical purposes that are worn on the examiner's hand to prevent contamination between patient and examiner.
The nitrile rubber is watertight under normal conditions of use. Its tensile properties cause it to conform to the hand, allowing movements necessary for the medical properties. ASTM conforming tensile properties create a glove that is strong and flexible. The glove is manufactured in accordance with the requirements of ASTM D6319-19 and ASTM D5151-19. This is a disposable device, intended for medical purposes, that is worn on the examiner's hand to prevent contamination between patient and examiner.
The provided text is a 510(k) premarket notification for "Powder Free Blue Nitrile Examination Gloves." This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study proving the device meets specific acceptance criteria for an AI/ML-driven medical device. Therefore, much of the requested information regarding AI/ML device performance and testing (e.g., sample sizes for test/training sets, expert ground truth establishment, MRMC studies, standalone performance, effect size of human reader improvement with AI assistance) is not applicable to this document.
However, the document does contain information about performance testing for the physical and biological properties of the gloves, which can be interpreted as "acceptance criteria" and "reported device performance."
Here's the information extracted from the document that is relevant to "acceptance criteria" and "study that proves the device meets the acceptance criteria" for these physical and biological properties:
1. A table of acceptance criteria and the reported device performance:
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Biocompatibility Testing: | ||
| Guinea Pig Sensitization | No deviations noted, observed, nor requiring clarification. Product is not a sensitizer. | No reaction/positive allergic reaction observed. Conforms to requirements. |
| Primary Dermal Irritation in Rabbits | No deviations noted, observed, nor requiring clarification. Product is not a primary irritant. Primary Irritation Index (PII) of 0. | PII was 0. Conforms to requirements. |
| Acute Systemic Cytotoxicity in Rats | No adverse reaction noted, observed, nor requiring clarification. No adverse biological reaction. | All animals survived, healthy, active, gained weight. No abnormalities in gross necropsies. Conforms to requirements. |
| Physical Properties Testing (ASTM D6319-19, D5151-19, D6124-06): | ||
| Watertight (Pinhole Test) per ASTM D5151-19 | Free from holes, AQL 1.5 (G1: AQL 2.5 for 1000mL test) | Pass (G1: AQL 2.5 for 1000mL test) |
| Length (mm) | Size S: Min 220; M, L, XL: Min 230 | 240mm minimum for all sizes |
| Palm Width (mm) | Size S: 80 ± 10; M: 95 ± 10; L: 110 ± 10; XL: 120 ± 10 | S: 84-86; M: 95-96; L: 108-109; XL: 114-115 |
| Thickness (mm) - Single Layer | Finger: Min 0.05; Palm: Min 0.05; Cuff: Min 0.05 | Finger: Min 0.06; Palm: Min 0.06; Cuff: Min 0.05 |
| Tensile Strength (MPa) - Before Aging | Min 14 | 17-23 |
| Ultimate Elongation (%) - Before Aging | Min 500 | 540-607 |
| Tensile Strength (MPa) - After Aging | Min 14 | 21-27 |
| Ultimate Elongation (%) - After Aging | Min 400 | 480-565 |
| Powder Content per ASTM D6124-06 | Max 2.0 mg/glove | Below 2.0 mg/glove |
2. Sample size used for the test set and the data provenance:
- Sample Size: The document does not explicitly state the sample sizes used for each specific test (e.g., number of gloves for watertightness, physical properties, or number of animals for biocompatibility). It references ASTM and ISO standards, which would define the required sample sizes for such tests.
- Data Provenance: Not explicitly stated, but the tests were performed on the "proposed device" (Powder Free Blue Nitrile Examination Gloves manufactured by Lienteh Technology Sdn Bhd in Malaysia). The tests are described as non-clinical "performance data of gloves based on animal studies, biocompatibility studies" and "performance data of gloves based on ASTM D6319-19 and FDA Watertight Test." This implies prospective laboratory testing of the manufactured product.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This is not an AI/ML device relying on human expert annotation for ground truth. The "ground truth" for the physical and biological properties is established by the specified ASTM/ISO standard testing methodologies and their defined criteria.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable. This document does not describe a study requiring human adjudication for test results; the outcomes are based on standardized laboratory measurements and observations according to specific protocols.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not Applicable. This device is an examination glove, not an AI/ML diagnostic aid influencing human reader performance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is not an AI algorithm. The performance described is the standalone performance of the physical glove itself.
7. The type of ground truth used:
- The "ground truth" is based on standardized testing protocols and criteria defined by:
- 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 (Reapproved 2017), (Standard test method for Residual powder on medical gloves)
- ASTM D412-16 (for physical properties like tensile strength and elongation)
- ISO 10993-10:2010 (Biological evaluation of medical devices- Part 10: Tests for Irritation and Skin Sensitization)
- ISO 10993-11 (Biological Evaluation of Medical devices- Part 11: Tests for Systemic toxicity)
- FDA watertight test AQL criteria (21 CFR 800.20)
8. The sample size for the training set:
- Not Applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established:
- Not Applicable. As above, it's not an AI/ML device.
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(146 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
The nitrile rubber is water tight under normal conditions of use. It's tensile properties cause it to conform to the hand, allowing movements necessary for a medical properties. ASTM conforming tensile properties create a glove that is strong and flexible. The glove is manufactured in accordance with the requirements of ASTM D6319 and ASTM D5151. This is a disposable device, intended for medical purposes, that is worn on the examiner's hand to prevent contamination between patient and examiner.
The provided document is a 510(k) summary for "Powder Free Blue Nitrile Examination Gloves" (K213107) and does not describe an AI medical device. Therefore, many of the requested fields are not applicable. This summary focuses on the safety and performance of physical medical gloves, primarily through non-clinical testing against established standards.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Method / Property | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| ASTM D 5151 (Pinhole) | Free from holes, AQL 1.5 | Pass |
| ASTM D6319 (Physical) | Before Aging: Tensile Strength: Min 14 MPa, Elongation: Min 500% | Pass |
| After Aging: Tensile Strength: Min 14 MPa, Elongation: Min 400% | Pass | |
| Watertight (1000mL) | Single Sampling in accordance with ISO 2859 G1: AQL 2.5 | Pass G1: AQL 2.5 |
| Length (mm) | Min 220 (S), Min 230 (M, L, XL) | 240mm minimum for all sizes |
| Palm width (mm) | 80 ± 10 (S), 95 ± 10 (M), 110 ± 10 (L), 120 ± 10 (XL) | 84-86 (S), 95-96 (M), 108-109 (L), 114-115 (XL) |
| Thickness (mm) | Min 0.05 (Finger, Palm, Cuff) | Min 0.06 (Finger), Min 0.06 (Palm), Min 0.05 (Cuff) |
| ASTM D412 (Physical) | Before Aging: Tensile Strength: Min 14 MPa, Elongation: Min 500% | 17-23 (Tensile Strength), 540-607 (Elongation) |
| After Aging: Tensile Strength: Min 14 MPa, Elongation: Min 400% | 21-27 (Tensile Strength), 480-565 (Elongation) | |
| ASTM D6124 (Powder) | Max 2.0 mg/glove | Below 2.0 mg/glove |
| Guinea Pig Sensitization | No deviations noted, no positive allergic reaction | No reaction observed, no positive allergic reaction. Meets conformance requirements. |
| Primary Dermal Irritation (Rabbits) | No deviations noted, identify primary irritants | Primary Irritation Index was 0. Meets conformance requirements. |
| Acute Systemic Cytotoxicity (Rats) | No adverse reaction noted | All animals survived, gained weight, no abnormalities in necropsies. Meets conformance requirements. |
2. Sample size used for the test set and the data provenance
The document does not explicitly state the exact sample sizes for each specific test (e.g., number of gloves tested for pinholes, physical properties, or biocompatibility). However, it refers to standards such as "Single Sampling in accordance with ISO 2859 G1" for the watertight test, which implies a statistically determined sample size based on the Acceptable Quality Level (AQL). The tests appear to be performed on the final and finished devices.
- Data Provenance: Not explicitly stated, but given the applicant's location (Novid PPE Sdn Bhd, Malaysia), the testing was likely conducted in Malaysia or a lab contracted by them. The tests are non-clinical, meaning they involve physical product testing and animal studies, not human patient data.
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 non-AI medical device (examination gloves). Ground truth for these tests is established by adherence to recognized international and national standards (e.g., ASTM, ISO) and laboratory protocols, not by expert consensus on clinical data.
4. Adjudication method for the test set
Not applicable. The tests are objective measurements against predefined criteria in established standards, not subjective assessments requiring 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 medical device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI medical device.
7. The type of ground truth used
For the performance and physical properties, the "ground truth" is defined by the specified minimum or maximum values and methodologies outlined in the referenced ASTM and ISO standards (e.g., ASTM D6319 for physical properties, ASTM D5151 for pinhole detection, ASTM D6124 for powder content). For biocompatibility, the ground truth is established by the absence of adverse biological reactions using standard animal testing protocols (ISO 10993-10, ISO 10993-11).
8. The sample size for the training set
Not applicable. This is not an AI medical device, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable. This is not an AI medical device.
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(362 days)
A Patient examination glove is a disposable device intended for medical purposes that worn on the examiner's hand or finger to prevent contamination between patient and examiner. Tested for use with chemotherapy drugs as listed below.
Powder Free Blue Nitrite Examination Gloves- Tested for Use with Chemotherapy Drugs.
This document describes the FDA's 510(k) clearance for "Powder Free Blue Nitrile Examination Gloves - Tested for Use with Chemotherapy Drugs" (K182089). The primary focus of the performance data in this document relates to the gloves' resistance to permeation by chemotherapy drugs.
Here's an analysis based on your request, using the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The "acceptance criteria" for gloves used with chemotherapy drugs are typically defined by regulatory bodies or consensus standards (like ASTM D6978, which is often referenced for chemotherapy glove testing) as a minimum breakthrough time. While explicit "acceptance criteria" values are not stated in this document as a separate column, the reported device performance clearly indicates whether the gloves meet the implied standard of extended protection (often >240 minutes for many drugs).
| Chemotherapy Drug | Concentration | Acceptance Criteria (Implied by standard practice, e.g., ASTM D6978) | Reported Device Performance (Breakthrough Detection Time) | Meets Implied Criteria? |
|---|---|---|---|---|
| Carmustine (BCNU) | 3.3 mg/ml | Typically >240 min desired | 9.0 min | No (specifically cautioned against) |
| Cisplatin | 1.0 mg/ml | Typically >240 min desired | >240 min | Yes |
| Cyclophosphamide (Cytoxan) | 20mg/ml | Typically >240 min desired | >240 min | Yes |
| Dacarbazine (DTIC) | 10.0 mg/ml | Typically >240 min desired | >240 min | Yes |
| Doxorubicin Hydrochloride | 2.0mg/ml | Typically >240 min desired | >240 min | Yes |
| Etoposide (Toposar) | 20.0 mg/ml | Typically >240 min desired | >240 min | Yes |
| Fluorouracil | 50.0 mg/ml | Typically >240 min desired | >240 min | Yes |
| Ifosfamide | 50.0 mg/ml | Typically >240 min desired | >240 min | Yes |
| Methotrexate | 25 mg/ml | Typically >240 min desired | >240 min | Yes |
| Mitomycin C | 0.5 mg/ml | Typically >240 min desired | >240 min | Yes |
| Mitoxantrone | 2.0 mg/ml | Typically >240 min desired | >240 min | Yes |
| Paclitaxel (Taxol) | 6.0 mg/ml | Typically >240 min desired | >240 min | Yes |
| Thio-Tepa | 10.0 mg/ml | Typically >240 min desired | 16.2 min | No (specifically cautioned against) |
| Vincristine Sulfate | 1.0 mg/ml | Typically >240 min desired | >240 min | Yes |
Note: The document explicitly states: "Please Note that Carmustine and Thio-Tepa have low permeation time of less than 240 minutes. Do not use with Carmustine and Thio-Tepa." This indicates that for these two drugs, the gloves did not meet the standard expectation for chemotherapy glove use, and this limitation is clearly communicated.
The subsequent questions (2-9) are primarily relevant to clinical studies involving AI or diagnostics that interpret medical data. This document describes the clearance of a medical device (gloves) based on laboratory testing for chemical permeation, not a clinical study involving human patients, expert readers, or AI algorithms. Therefore, most of these questions are not applicable to the provided information.
However, I will address those that can be inferred or directly commented on:
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not explicitly stated in terms of number of gloves tested, but it would involve multiple samples of the glove material subjected to permeation testing according to a standard like ASTM D6978. For each chemotherapy drug listed, a sample of the glove material would be exposed, and the time until breakthrough is detected would be measured.
- Data Provenance: The document implies laboratory testing conducted by the manufacturer or a certified lab. The country of origin of the data is not specified beyond the manufacturer being "Platinum Glove Industries Sdn Bhd" from "Malaysia." This is retrospective testing of the glove material properties.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This is not a study involving human interpretation of medical data where "ground truth" is established by experts. The "ground truth" in this context is the physical property of the glove's resistance to chemical permeation, measured by laboratory instrumentation and protocols (e.g., using a permeation cell and analytical detection methods).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. See point 3.
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 a clinical or AI-based diagnostic study.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not Applicable. This is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" in this context is the measured chemical permeation time of specific chemotherapy drugs through the glove material, determined through standardized laboratory testing (e.g., in accordance with ASTM D6978 or an equivalent standard).
8. The sample size for the training set:
- Not Applicable. This is not an AI or machine learning study, so there is no "training set."
9. How the ground truth for the training set was established:
- Not Applicable. See point 8.
Ask a specific question about this device
(199 days)
A Patient examination glove is a disposable device intended for medical purposes that worn on the examiner's hand or finger to prevent contamination between patient and examiner. Tested for use with chemotherapy drugs as listed below.
Powder Free Blue Nitrile Examination Gloves - Tested for Use with 32 Chemotherapy Drugs and Fentanyl Citrate
The provided document is an FDA 510(k) clearance letter for "Powder Free Blue Nitrile Examination Gloves - Tested for use with 32 Chemotherapy Drugs and Fentanyl Citrate." This document primarily focuses on the substantial equivalence determination for a medical device (gloves) and its performance against chemical permeation for certain drugs.
The request asks for information typically found in the clinical validation of AI/ML-based medical devices or diagnostic tools. The provided document does not contain any information related to AI/ML device performance, test sets, ground truth establishment, expert adjudication, or MRMC studies. It is a regulatory clearance for a physical medical device (gloves) based on chemical permeation testing, not an AI system.
Therefore, I cannot provide the requested information. The document details chemical resistance and breakthrough times, not AI algorithm performance.
However, if we were to interpret the document's content as "acceptance criteria" and "device performance" in the context of the gloves' chemical resistance, the information could be presented as follows:
Acceptance Criteria and Device Performance (Based on Chemical Permeation Testing for Gloves)
Given the nature of the device (examination gloves) and the provided data, the "Acceptance Criteria" are implicitly derived from the testing standards for medical gloves' resistance to chemotherapy drugs and fentanyl citrate. The "Device Performance" refers to the measured breakthrough times. For regulated medical gloves, the expectation is generally to demonstrate sufficient resistance (i.e., a "breakthrough detection time" that meets or exceeds a certain threshold, often >240 minutes, indicating prolonged protection).
1. Table of Acceptance Criteria and Reported Device Performance
| Chemotherapy Drugs: | Acceptance Criteria (e.g., Target Breakthrough Time) | Reported Device Performance (Breakthrough Detection Time in Minutes) |
|---|---|---|
| 1. Carmustine (BCNU)3.3 mg/ml(3,300 ppm) | To be defined by standard (e.g., >x min) | 54.8 min |
| 2. Cisplatin 1.0 mg/ml (1,000ppm) | To be defined by standard (e.g., >x min) | >240 min |
| 3. Cyclophosphamide (Cytoxan) 20mg/ml(20,000ppm) | To be defined by standard (e.g., >x min) | >240 min |
| 4. Dacarbazine (DTIC)10.0 mg/ml(10,000ppm) | To be defined by standard (e.g., >x min) | >240 min |
| 5. Doxorubicin Hydrochloride 2.0 mg/ml (2,000ppm) | To be defined by standard (e.g., >x min) | >240 min |
| 6. Etoposide (Toposar) 20.0 mg/ml (20,000ppm) | To be defined by standard (e.g., >x min) | >240 min |
| 7. Fluorouracil 50.0 mg/ml (50,000ppm) | To be defined by standard (e.g., >x min) | >240 min |
| 8. Ifosfamide 50.0 mg/ml (50,000ppm) | To be defined by standard (e.g., >x min) | >240 min |
| 9. Methotrexate 25 mg/ml (25,000ppm) | To be defined by standard (e.g., >x min) | >240 min |
| 10.Mitomycin C 0.5 mg/ml (500ppm) | To be defined by standard (e.g., >x min) | >240 min |
| 11. Mitoxantrone 2.0 mg/ml (2,000ppm) | To be defined by standard (e.g., >x min) | >240 min |
| 12. Paclitaxel (Taxol) 6.0 mg/ml (6,000ppm) | To be defined by standard (e.g., >x min) | >240 min |
| 13. Thio-Tepa 10.0 mg/ml (10,000ppm) | To be defined by standard (e.g., >x min) | 46.9 min |
| 14. Vincristine Sulfate 1.0 mg/ml (1,000ppm) | To be defined by standard (e.g., >x min) | >240 min |
| 15. Amethopterin (Methotrexate) 25 mg/ml, (25,000 ppm) | To be defined by standard (e.g., >x min) | >240 min |
| 16. Bleomycin 15 mg/ml (15,000 ppm) | To be defined by standard (e.g., >x min) | >240 min |
| 17. Busulfan 6 mg/ml (6,000 ppm) | To be defined by standard (e.g., >x min) | >240 min |
| 18. Carboplatin 10 mg/ml (10,000 ppm) | To be defined by standard (e.g., >x min) | >240 min |
| 19. Cytarabine 100 mg/ml (100.000 ppm) | To be defined by standard (e.g., >x min) | >240 min |
| 20. Daunorubicin 5 mg/ml (5,000 ppm) | To be defined by standard (e.g., >x min) | >240 min |
| 21. Doxetacel 10.0 mg/ml (10,000 ppm) | To be defined by standard (e.g., >x min) | >240 min |
| 22. Ellence 2 mg/ml (2,000 ppm) | To be defined by standard (e.g., >x min) | >240 min |
| 23. Fludarabine 25 mg/ml (25,000 ppm) | To be defined by standard (e.g., >x min) | >240 min |
| 24. Gemcitabine (Gemzar) 38 mg/ml (38,000 ppm) | To be defined by standard (e.g., >x min) | >240 min |
| 25. Idarubicin 1 mg/ml (1,000 ppm) | To be defined by standard (e.g., >x min) | >240 min |
| 26. Irinotecan 20.0 mg/ml (20,000 ppm) | To be defined by standard (e.g., >x min) | >240 min |
| 27. Mechloretamine HCL 1.0 mg/ml (1,000 ppm) | To be defined by standard (e.g., >x min) | >240 min |
| 28. Melphalan 5 mg/ml (5,000 ppm) | To be defined by standard (e.g., >x min) | >240 min |
| 29. Oxaliplatin 2.0 mg/ml (2,000 ppm) | To be defined by standard (e.g., >x min) | >240 min |
| 30. Rituximab 10 mg/ml (10,000 ppm) | To be defined by standard (e.g., >x min) | >240 min |
| 31. Trisonex 0.1 mg/ml (100 ppm) | To be defined by standard (e.g., >x min) | >240 min |
| 32. Vinorelbin 10 mg/ml (10,000 ppm) | To be defined by standard (e.g., >x min) | >240 min |
| Fentanyl Citrate Injection 100 mcg/2ml | To be defined by standard (e.g., >x min) | >240min |
Note: The document highlights "Please Note that the following Drugs have extremely low permeation times : Carmustine : 54,8 minutes and Thio-Tepa: 46.9 minutes," indicating these may be areas where performance is lower relative to other tested drugs, but still acceptable under relevant standards for their intended use and risk mitigation strategies.
For the remainder of the questions, as stated, the provided document does not contain this information as it pertains to AI/ML device validation, not the direct chemical permeation testing of physical gloves.
- 2. Sample size used for the test set and the data provenance: Not applicable. This refers to the number of gloves tested for chemical resistance, not a dataset for an AI model. The document does not specify the exact number of gloves or samples, nor their country of origin for testing purposes. The testing is laboratory-based chemical permeation.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for chemical permeation is established by analytical chemistry methods (e.g., spectroscopy) that detect the breakthrough of a chemical through the glove material over time, not by human expert opinion.
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. Chemical permeation testing uses objective measurement, not human 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 applies to diagnostic AI, not chemical resistance of gloves.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This applies to diagnostic AI, not chemical resistance of gloves.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): The ground truth for glove performance is the precise measurement of chemical permeation/breakthrough time under controlled laboratory conditions, typically following standards like ASTM D6978.
- 8. The sample size for the training set: Not applicable. This is not an AI/ML device.
- 9. How the ground truth for the training set was established: Not applicable. This is not an AI/ML device.
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(102 days)
The Powder Free Blue Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.
The proposed device was tested for use with Chemotherapy Drugs as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
The proposed device, Powder Free Blue Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.
The proposed device is a Powder Free Nitrile Patient Examination Glove that is available in multiple sizes
The proposed device is provided non-sterile. The proposed device is made of Nitrile. The proposed device acts as a barrier.
Here's a breakdown of the acceptance criteria and study information for the Powder Free Blue Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs, based on the provided FDA 510(k) submission.
1. Table of Acceptance Criteria and Reported Device Performance
The device is evaluated against specific ASTM standards for various properties and against a predicate device (K163146) for comparison. The key acceptance criteria and reported performance for critical aspects are as follows:
| Acceptance Criteria (Standard / Property) | Specific Requirement (as per standard) | Proposed Device Performance | Met Criteria? |
|---|---|---|---|
| Chemotherapy Drug Permeation | Breakthrough Detection Time: > 240 minutes for most drugs, except where noted by predicate | Varies per drug (see table below) | Met for most, not for Carmustine and Thiotepa (but disclosed) |
| Dimension (Length) | >= 230 mm (min) | 230 mm (all sizes) | Yes |
| Dimension (Width) | Varies per size (e.g., 70-120 mm) ±10 | Matches requirement | Yes |
| Dimension (Thickness - Finger) | 0.07 mm ±0.02 (for proposed) | 0.07 mm ±0.02 (specified) | Yes (meets own spec) |
| Dimension (Thickness - Palm) | 0.05 mm (min, for proposed) | 0.05 mm (specified) | Yes (meets own spec) |
| Dimension (Thickness - Cuff) | 0.05 mm ±0.02 (for proposed) | 0.05 mm ±0.02 (specified) | Yes (meets own spec) |
| Tensile Strength (Before Aging) | 15 MPa, min (ASTM D6319) | 15 MPa, min | Yes |
| Ultimate Elongation (Before Aging) | 500% min (ASTM D6319) | 500% min | Yes |
| Tensile Strength (After Aging) | 14 MPa, min (ASTM D6319) | 14 MPa, min | Yes |
| Ultimate Elongation (After Aging) | 400% min (ASTM D6319) | 400% min | Yes |
| Detection of Holes | Not detected (ASTM D5151) | Not detected | Yes |
| Powder Content | Max. 0.35 mg per glove (specified for proposed, meets ASTM D6319) | Max. 0.35 mg per glove | Yes (meets own spec) |
| Biocompatibility (Irritation) | Not an irritant (ISO 10993-10) | Not an irritant | Yes |
| Biocompatibility (Sensitization) | Not a sensitizer (ISO 10993-10) | Not a sensitizer | Yes |
| Biocompatibility (In Vitro Cytotoxicity) | Not cytotoxic (ISO 10993-5) | Not cytotoxic | Yes |
Chemotherapy Drug Permeation Performance and Acceptance Criteria (from tables on pages 2 and 5-6):
The acceptance criterion for chemotherapy drug permeation is generally a breakthrough detection time of >240 minutes, as demonstrated by most drugs. However, for Carmustine and Thiotepa, lower breakthrough times are explicitly noted and acknowledged. The device performance for these drugs is compared against the general expectation and specific values are provided.
| Chemotherapy Drug | Concentration | Breakthrough Detection Time in Minutes (Reported Device Performance) | Acceptance Criteria Met? (Based on general >240 min, or specific disclosure for lower times) |
|---|---|---|---|
| Bleomycin | 15 mg/ml (15,000 ppm) | >240 | Yes |
| Busulfan | 6 mg/ml (6,000 ppm) | >240 | Yes |
| Carboplatin | 10 mg/ml (10,000ppm) | >240 | Yes |
| Carmustine (BCNU) | 3.3 mg/ml (3,300ppm) | 8.5 (12.7, 13.4, 8.5) (Noted as having low permeation time) | Yes (Disclosed and acceptable with warning) |
| Cisplatin | 1.0 mg/ml (1,000ppm) | >240 | Yes |
| Cyclophosphamide(Cytoxan) | 20.0 mg/ml (20,000ppm) | >240 | Yes |
| Cytarabine | 100 mg/ml (100,000ppm) | >240 | Yes |
| Cytovene | 10 mg/ml (10,000ppm) | >240 | Yes |
| Dacarbazine(DTIC) | 10.0 mg/ml (10,000ppm) | >240 | Yes |
| Daunorubicin | 5 mg/ml (5,000ppm) | >240 | Yes |
| Docetaxel | 10.0 mg/ml(10,000 ppm) | >240 | Yes |
| Doxorubicin Hydrochloride | 2.0 mg/ml (2,000ppm) | >240 | Yes |
| Ellence | 2 mg/ml (2,000ppm) | >240 | Yes |
| Etoposide(Toposar) | 20.0 mg/ml(20,000ppm) | >240 | Yes |
| Fludarabine | 25 mg/ml(25,000ppm) | >240 | Yes |
| Fluorouracil | 50 mg/ml(50,000ppm) | >240 | Yes |
| Gemcitabine (Gemzar) | 38 mg/ml(38,000ppm) | >240 | Yes |
| Idarubicin | 1 mg/ml (1,000ppm) | >240 | Yes |
| Ifosfamide | 50.0 mg/ml (50,000ppm) | >240 | Yes |
| Irinotecan | 20.0 mg/ml (20,000ppm) | >240 | Yes |
| Mechlorethamine HCI | 1.0 mg/ml (1,000ppm) | >240 | Yes |
| Melphalan | 5 mg/ml (5,000ppm) | >240 | Yes |
| Methotrexate | 25mg/ml (25,000ppm) | >240 | Yes |
| Mitomycin C | 0.5 mg/ml (500 ppm) | >240 | Yes |
| Mitoxantrone | 2.0 mg/ml(2,000ppm) | >240 | Yes |
| Oxaliplatin | 2.0 mg/ml(2,000ppm) | >240 | Yes |
| Paclitaxel (Taxol) | 6.0 mg/ml(6,000ppm) | >240 | Yes |
| Rituximab | 10 mg/ml(10,000ppm) | >240 | Yes |
| Thiotepa | 10.0 mg/ml (10,000ppm) | 36.1 (51.2, 36.1, 45.6) (Noted as having low permeation time) | Yes (Disclosed and acceptable with warning) |
| Trisenox | 0.1 mg/ml (100ppm) | >240 | Yes |
| Vincristine Sulfate | 1.0 mg/ml (1,000ppm) | >240 | Yes |
| Vinorelbine | 10 mg/ml(10,000ppm) | >240 | Yes |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the exact sample size for each specific test. However, it indicates that "Bench tests were conducted to verify that the proposed device met all specifications."
- Sample Size: Not explicitly stated as a numerical value for each test. The adherence to standards like ASTM D6319, ASTM D5151, ASTM D6124, ASTM D6978, ISO 2859-1, ISO 10993-10, and ISO 10993-5 implies that appropriate sample sizes, as dictated by these standards, were used for testing various properties (e.g., AQL for holes, specific number of samples for mechanical properties and chemical permeation). ISO 2859-1 specifically relates to "Sampling Procedures for Inspection by Attributes – Part I: Sampling Plans Indexed by Acceptable Quality Level (AQL) for Lot-by-Lot Inspection," indicating a quality control sampling approach for certain attributes.
- Data Provenance: The tests were non-clinical bench tests conducted to evaluate the physical, performance, and biocompatibility characteristics of the gloves. The country of origin for the manufacturing company is China (Hebei Titans Hongsen Medical Technology Co., LTD.). The submission is for a medical device (gloves), and the testing appears to be prospective in nature, conducted specifically for this 510(k) submission to demonstrate compliance with standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is not applicable to this submission. The device is a medical glove, and its performance is evaluated against established physical, chemical, and biological standards (ASTM and ISO). The "ground truth" here is the pass/fail criteria defined by these objective engineering and material science standards, not subjective human interpretations or expert consensus on medical images or diagnoses.
4. Adjudication Method for the Test Set
This is not applicable as the evaluation is based on objective, standardized test methods with clear pass/fail criteria, not on subjective expert review requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
This is not applicable. This submission is for a medical device (gloves) and does not involve AI or human readers for diagnostic or interpretive tasks.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This is not applicable. This submission is not for an algorithm or AI device.
7. The Type of Ground Truth Used
The "ground truth" in this context refers to the established scientific and engineering standards and their predefined pass/fail criteria. These include:
- ASTM D6319-10: Standard Specification for Nitrile Examination Gloves for Medical Application (for dimensions, physical properties).
- ASTM D5151-06: Standard Test Method for Detection of Holes in Medical Gloves.
- ASTM D6124-06: Standard Test Method for Residual Powder on Medical Gloves.
- ASTM D6978-05: Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs (for chemical permeation).
- ISO 2859-1:1999: Sampling Procedures for Inspection by Attributes – Part I: Sampling Plans Indexed by Acceptable Quality Level (AQL) for Lot-by-Lot Inspection.
- ISO 10993-10: 2010: 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.
The performance values obtained from the actual testing of the gloves are compared directly against the quantitative limits set forth in these standards.
8. The Sample Size for the Training Set
This is not applicable. The device is a physical product (gloves) and does not involve a "training set" in the context of machine learning or AI models.
9. How the Ground Truth for the Training Set Was Established
This is not applicable for the same reason as point 8.
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