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510(k) Data Aggregation
(81 days)
Powder Free Nitrile Patient Examination Glove, Black Colored, Non-Sterile
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. These gloves were tested for use with chemotherapy drugs and Fentanyl Citrate as per ASTM D6978-05 (Reapproved 2013) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
Powder Free Nitrile Patient Examination Glove, Black Colored, Non-Sterile, Low Dermatitis Potential. Tested for Use with Chemotherapy Drugs and Fentanyl Citrate.
This document describes the acceptance criteria and the study results for Kossan International Sdn. Bhd.'s Powder Free Nitrile Patient Examination Gloves.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the gloves are based on their resistance to permeation by chemotherapy drugs and Fentanyl Citrate, as determined by ASTM D6978-05 (Reapproved 2013). The reported device performance is the "Minimum Breakthrough Detection Time in Minutes" for each substance.
| Chemotherapy Drug and Concentration | Acceptance Criteria (Minimum Breakthrough Detection Time in Minutes) | Reported Device Performance (Minimum Breakthrough Detection Time in Minutes) |
|---|---|---|
| Carmustine (BCNU) (3.3 mg/ml) | (Not explicitly defined, but a longer time is better) | 25.2 |
| Cisplatin (1.0 mg/ml) | (Not explicitly defined, but a longer time is better) | >240 |
| Cyclophosphamide (Cytoxan) (20.0 mg/ml) | (Not explicitly defined, but a longer time is better) | >240 |
| Cytarabine (100 mg/ml) | (Not explicitly defined, but a longer time is better) | >240 |
| Dacarbazine (DTIC) (10.0 mg/ml) | (Not explicitly defined, but a longer time is better) | >240 |
| Doxorubicin Hydrochloride (2.0 mg/ml) | (Not explicitly defined, but a longer time is better) | >240 |
| Etoposide (20.0 mg/ml) | (Not explicitly defined, but a longer time is better) | >240 |
| Fluorouracil (50.0 mg/ml) | (Not explicitly defined, but a longer time is better) | >240 |
| Ifosfamide (50.0 mg/ml) | (Not explicitly defined, but a longer time is better) | >240 |
| Methotrexate (25.0 mg/ml) | (Not explicitly defined, but a longer time is better) | >240 |
| Mitomycin C (0.5 mg/ml) | (Not explicitly defined, but a longer time is better) | >240 |
| Mitoxantrone (2.0 mg/ml) | (Not explicitly defined, but a longer time is better) | >240 |
| Paclitaxel (Taxol) (6.0 mg/ml) | (Not explicitly defined, but a longer time is better) | >240 |
| Thiotepa (10.0 mg/ml) | (Not explicitly defined, but a longer time is better) | 35.9 |
| Vincristine Sulfate (1.0 mg/ml) | (Not explicitly defined, but a longer time is better) | >240 |
| Fentanyl Citrate Injection (100 mcg/2ml) | (Not explicitly defined, but a longer time is better) | >240 |
| Simulated Gastric Acid Fluid | (Not explicitly defined, but a longer time is better) | >240 |
Note: While specific numerical "acceptance criteria" are not explicitly stated as pass/fail thresholds in the document for each drug, the implication of conducting the test and reporting breakthrough times is that these values met the manufacturer's internal standards and/or the expectations for substantial equivalence based on the ASTM D6978-05 standard. The goal is to maximize the breakthrough time for safety.
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample size (number of gloves or trials) used for the permeation tests. It only states that the gloves "were tested for use with chemotherapy drugs and Fentanyl Citrate as per ASTM D6978-05 (Reapproved 2013) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs." Following an ASTM standard typically implies a specific number of replicates, but this detail is not provided.
The data provenance is from prospective testing conducted by the manufacturer according to the specified ASTM standard. The country of origin of the data is not explicitly stated, but the manufacturer, Kossan International Sdn. Bhd., is based in Malaysia.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is not applicable to this type of device and study. The "ground truth" for glove permeation is established by objective laboratory measurements using analytical techniques to detect the breakthrough of chemical substances, not by expert interpretation.
4. Adjudication method for the test set
This is not applicable. Adjudication methods are typically used in studies involving human interpretation or clinical endpoints. For a technical performance test like chemical permeation, the results are objective measurements.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This is not applicable. This document pertains to the performance of examination gloves against chemical permeation, not a diagnostic device involving human readers or AI.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is not applicable. This document pertains to the performance of examination gloves against chemical permeation, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth used is objective laboratory measurement (detection of chemical permeation through the glove material) based on the methodology outlined in ASTM D6978-05.
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 algorithms.
9. How the ground truth for the training set was established
This is not applicable for the same reason as above (physical product, no training set).
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(130 days)
Examination Glove, White Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Powder
Free Nitrile Patient Examination Glove, Black Colored, Non-Sterile, Tested for Use with Chemotherapy
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. These gloves were tested for use with chemotherapy drugs and Fentanyl Citrate per ASTM D6978-05 (Reapproved 2013) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
Not Found
Here's a breakdown of the acceptance criteria and study information for the Powder Free Nitrile Patient Examination Gloves, based on the provided document:
Acceptance Criteria and Reported Device Performance
The device, Powder Free Nitrile Patient Examination Gloves (Blue, White, and Black Colored), was tested for permeation by chemotherapy drugs and Fentanyl Citrate according to ASTM D6978-05 (Reapproved 2013) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
The acceptance criteria are implied to be the reported "Minimum Breakthrough Detection Time in Minutes" for each drug, which the device performance meets or exceeds.
Device Performance Tables:
1. Blue Colored Gloves:
| Chemotherapy Drug and Concentration | Minimum Breakthrough Detection Time in Minutes |
|---|---|
| Carmustine (BCNU) (3.3 mg/ml) | 10.1 |
| Cisplatin (1.0 mg/ml) | >240 |
| Cyclophosphamide (Cytoxan) (20.0 mg/ml) | >240 |
| Cytarabine(100 mg/ml) | >240 |
| Dacarbazine (DTIC) (10.0 mg/ml) | >240 |
| Doxorubicin Hydrochloride (2.0 mg/ml) | >240 |
| Etoposide (20.0 mg/ml) | >240 |
| Fluorouracil (50.0 mg/ml) | >240 |
| Ifosfamide (50.0 mg/ml) | >240 |
| Methotrexate (25.0 mg/ml) | >240 |
| Mitomycin C (0.5 mg/ml) | >240 |
| Mitoxantrone (2.0 mg/ml) | >240 |
| Paclitaxel (Taxol) (6.0 mg/ml) | >240 |
| Thiotepa (10.0 mg/ml) | 30.2 |
| Vincristine Sulfate (1.0 mg/ml) | >240 |
Note: Carmustine (BCNU) has an extremely low permeation time of 10.1 minutes.
| Fentanyl Citrate and Concentration | Minimum Breakthrough Detection Time in Minutes |
|---|---|
| Fentanyl Citrate Injection (100 mcg/2ml) | >240 |
2. White Colored Gloves:
| Chemotherapy Drug and Concentration | Minimum Breakthrough Detection Time in Minutes |
|---|---|
| Carmustine (BCNU) (3.3 mg/ml) | 10.1 |
| Cisplatin (1.0 mg/ml) | >240 |
| Cyclophosphamide (Cytoxan) (20.0 mg/ml) | >240 |
| Cytarabine(100 mg/ml) | >240 |
| Dacarbazine (DTIC) (10.0 mg/ml) | >240 |
| Doxorubicin Hydrochloride (2.0 mg/ml) | >240 |
| Etoposide (20.0 mg/ml) | >240 |
| Fluorouracil (50.0 mg/ml) | >240 |
| Ifosfamide (50.0 mg/ml) | >240 |
| Methotrexate (25.0 mg/ml) | >240 |
| Mitomycin C (0.5 mg/ml) | >240 |
| Mitoxantrone (2.0 mg/ml) | >240 |
| Paclitaxel (Taxol) (6.0 mg/ml) | >240 |
| Thiotepa (10.0 mg/ml) | 10.4 |
| Vincristine Sulfate (1.0 mg/ml) | >240 |
Note: Carmustine (BCNU) and Thiotepa have extremely low permeation times: 10.1 minutes and 10.4 minutes, respectively.
| Fentanyl Citrate and Concentration | Minimum Breakthrough Detection Time in Minutes |
|---|---|
| Fentanyl Citrate Injection (100 mcg/2ml) | >240 |
3. Black Colored Gloves:
| Chemotherapy Drug and Concentration | Minimum Breakthrough Detection Time in Minutes |
|---|---|
| Carmustine (BCNU) (3.3 mg/ml) | 14.4 |
| Cisplatin (1.0 mg/ml) | >240 |
| Cyclophosphamide (Cytoxan) (20.0 mg/ml) | >240 |
| Cytarabine(100 mg/ml) | >240 |
| Dacarbazine (DTIC) (10.0 mg/ml) | >240 |
| Doxorubicin Hydrochloride (2.0 mg/ml) | >240 |
| Etoposide (20.0 mg/ml) | >240 |
| Fluorouracil (50.0 mg/ml) | >240 |
| Ifosfamide (50.0 mg/ml) | >240 |
| Methotrexate (25.0 mg/ml) | >240 |
| Mitomycin C (0.5 mg/ml) | >240 |
| Mitoxantrone (2.0 mg/ml) | >240 |
| Paclitaxel (Taxol) (6.0 mg/ml) | >240 |
| Thiotepa (10.0 mg/ml) | 29.2 |
| Vincristine Sulfate (1.0 mg/ml) | >240 |
Note: Carmustine (BCNU) and Thiotepa have extremely low permeation times: 14.4 minutes and 29.2 minutes, respectively.
| Fentanyl Citrate and Concentration | Minimum Breakthrough Detection Time in Minutes |
|---|---|
| Fentanyl Citrate Injection (100 mcg/2ml) | >240 |
Study Information:
2. Sample size used for the test set and the data provenance:
- The document implies that the "test set" consists of multiple samples of each glove type (Blue, White, Black) that were subjected to testing against the listed chemotherapy drugs and Fentanyl Citrate.
- The exact sample size (number of gloves or individual tests) is not explicitly stated in the provided text.
- The data provenance is not definitively stated, but it is a premarket notification (510(k)) from a Malaysian company (Kossan International Sdn. Bhd.). It is implied that the testing was conducted to support this submission, likely by or for the manufacturer. The data is retrospective in relation to the submission date.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not applicable as the study involves laboratory testing for chemical permeation, not clinical performance or image interpretation requiring expert opinion. The "ground truth" is established by the direct measurement of chemical breakthrough time following the ASTM D6978-05 standard.
4. Adjudication method for the test set:
- This information is not applicable for a laboratory chemical permeation test. The results are quantitative measurements obtained through instrument analysis.
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 as the device is a patient examination glove, not an AI-powered diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This is not applicable as the device is a physical medical glove and does not involve an algorithm. The testing described is for the barrier properties of the glove material.
7. The type of ground truth used:
- The ground truth is based on direct laboratory measurement of chemical permeation/breakthrough time, as defined by the ASTM D6978-05 (Reapproved 2013) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
8. The sample size for the training set:
- This is not applicable as the study does not involve an algorithm or machine learning that requires a training set. The data presented is the result of direct physical and chemical property testing.
9. How the ground truth for the training set was established:
- This is not applicable as there is no training set for this type of device and study.
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(104 days)
Powder Free Nitrile Patient Examination Glove, Black Colored, Non-Sterile
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
Powder Free Nitrile Patient Examination Glove, Black Colored, Non-Sterile is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
The gloves are powder free, ambidextrous with beaded-cuff, black colored, single-use disposable devices that come in six sizes (XS, S, M, L, XL, XXL), and supplied in Non-Sterile state.
The gloves are made of Nitrile Butadiene Rubber, designed and manufactured in accordance with ASTM D6319-10, Standard Specification for Nitrile Examination Gloves for Medical Application.
Its physical and performance characteristics meet all requirements of ASTM D6319-10.
The provided document describes the acceptance criteria and performance of the Kossan International Sdn. Bhd. Powder Free Nitrile Patient Examination Glove, Black Colored, Non-Sterile (K143131). This is a medical device, and the "study" referred to is the non-clinical testing performed to demonstrate substantial equivalence to a predicate device.
Here's the information extracted and organized as requested:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Acceptance Criteria (Standards Requirements) | Reported Device Performance (Results Summary) |
|---|---|---|
| Dimensions | ASTM D6319-10 (Length $\ge$ 230mm, Palm Thickness $\ge$ 0.05mm, Finger Thickness $\ge$ 0.05mm, Specific Width ranges for XS, S, M, L, XL, XXL) | Meets Standard Requirements (Explicit values not provided in summary, but stated agreement with standard) |
| Physical Properties | ASTM D6319-10 (Before Aging: Tensile Strength $\ge$ 14 MPA, Elongation $\ge$ 500%; After Aging: Tensile Strength $\ge$ 14 MPA, Elongation $\ge$ 400%) | Meets Standard Requirements (Explicit values not provided in summary, but stated agreement with standard) |
| Freedom from Pinholes | ASTM D5151-11, ASTM D6319-10 (Pass quality level at G1 AQL 1.5) | Tested in accordance with ASTM D5151 test method. Pass quality level at G1 AQL 1.5. Meets Standard Requirements. |
| Powder Free Residue | ASTM D6124-11, ASTM D6319-10 (Values $\le$ 2 mg of residual powder per glove) | Result generated values $\le$ 2 mg of residual powder per glove. Meets Standard Requirements. |
| Biocompatibility | Dermal Sensitization (as ISO 10993-10:2010), Primary Skin Irritation Test (as ISO 10993-10:2010) | Dermal Sensitization: Magnusson & Kligman Scale is '0'. Device is not a sensitizer. Meets Standard Requirements. |
| Primary Skin Irritation: Primary Irritation Index for Erythema and Edema is '0'. Device is not an irritant. Meets Standard Requirements. |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes (number of gloves or animals/humans) used for each non-clinical test (dimensions, physical properties, pinholes, powder residue, biocompatibility). It only references adherence to ASTM and ISO standards, which would dictate appropriate sample sizes for each test.
- Data Provenance: The tests were conducted by Kossan International Sdn. Bhd. (Malaysia), making the data provenance likely from Malaysia. The data is non-clinical/laboratory test data, not patient data, so "retrospective or prospective" is not an applicable distinction in this context.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable. The "ground truth" for this device's performance is established by objective measurements against recognized industry standards (ASTM, ISO) in a laboratory setting, not by expert consensus on clinical findings. Therefore, no experts were used to establish a clinical ground truth for the test set in the traditional sense of medical image analysis or diagnostic studies.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies where multiple human readers assess data (e.g., images), and discrepancies need to be resolved. For non-clinical, objective laboratory tests of physical properties and biocompatibility, the results are typically determined by measurements and observations according to established protocols, not by 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
No MRMC comparative effectiveness study was done. This document pertains to the regulatory clearance of a physical medical device (examination gloves) based on non-clinical performance and biocompatibility data. It does not involve AI or human readers for diagnostic assessment.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. This document is about a physical medical device, not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" is based on objective laboratory measurements and tests against predefined industry standards (ASTM D6319-10, ASTM D5151-11, ASTM D6124-11, ISO 10993-10:2010 for biocompatibility). For example:
- Physical dimensions: measured values compared to specified ranges.
- Physical properties (tensile strength, elongation): measured values compared to minimum requirements.
- Freedom from pinholes: water leak test results compared to AQL.
- Powder free residue: measured weight of residual powder compared to maximum limit.
- Biocompatibility: animal study results (Magnusson & Kligman Scale, Primary Irritation Index) compared to "non-sensitizer" and "non-irritant" conclusions.
8. The sample size for the training set
This information is not applicable. This is not an AI/machine learning device. No training set was used.
9. How the ground truth for the training set was established
This information is not applicable. This is not an AI/machine learning device. No training set was used.
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