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510(k) Data Aggregation
(202 days)
Nephron Nitrile™, Nitrile Powder-Free Examination Gloves Black (Tested For Use With Chemotherapy Drugs and Fentanyl) is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
In addition, these gloves were tested for use with Chemotherapy drugs and Fentanyl in accordance with ASTM D6978-05 (2019) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.
The following chemotherapy drugs and concentration had NO breakthrough detected up to 240 minutes:
Bleomycin Sulfate (15.0 mg/ml) Busulfan (6.0 mg/ml) Carboplatin (10.0 mg/ml) Cisplatin (1.0 mg/ml) Cyclophosphamide (20.0 mg/ml) Cytarabine (100.0 mg/ml) Dacarbazine (10.0 mg/ml) Daunorubicin HCl (5.0 mg/ml) Docetaxel (10.0 mg/ml) Doxorubicin HCl (2.0 mg/ml) Epirubicin HCl (2.0 mg/ml) Etoposide (20.0 mg/ml) Fludarabine (25.0 mg/ml) Fluorouracil (50.0 mg/ml) Gemcitabine (38.0 mg/ml) Idarubicin HCl (1.0 mg/ml) Ifosfamide (50.0 mg/ml) Irinotecan (20.0 mg/ml) Mechlorethamine HCl (1.0 mg/ml) Melphalan (5.0 mg/ml) Methotrexate (25.0 mg/ml) Mitomycin C (0.5 mg/ml) Mitoxantrone HCl (2.0 mg/ml) Paclitaxel (6.0 mg/ml) Rituximab (10.0 mg/ml) Trisenox (1.0 mg/ml) Vincristine Sulfate (1.0 mg/ml)
The tested Opioid is: Fentanyl Citrate Injection (100 mcg/2 mL) Permeation: no breakthrough up to 240 minutes
The following chemotherapy drugs have low permeation times: Carmustine (3.3 mg/ml) : 26.3 minutes Thiotepa (10.0 mg/ml) : 49.1 minutes Warning: Not for Use with: Carmustine, Thiotepa
Nephron Nitrile™, Nitrile Powder-Free Examination Gloves Black (Tested For Use With Chemotherapy Drugs and Fentanyl) are Class I patient examination gloves, bearing the product codes LZA, LZC, OPJ, QDO (21 CFR 880.6250). They meet all the current specifications listed under the ASTM D6319-19, Standard Specification for Nitrile Examination Gloves for Medical Application and also complies with requirements for Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs as per ASTM D6978-05 (2019). The powder-free gloves are made from Nitrile (NBR) latex and are black in color. The product is non-sterile, fingertip textured, ambidextrous with beaded cuff, and single use only.
Nephron Nitrile™, Nitrile Powder-Free Examination Gloves Black (Tested For Use With Chemotherapy Drugs and Fentanyl) include glove sizes: X-Small, Medium, Large, X-Large and XX-Large.
The provided text describes the acceptance criteria and the results of a study for the "Nephron Nitrile™, Nitrile Powder-Free Examination Gloves Black (Tested For Use With Chemotherapy Drugs and Fentanyl)".
Here's a breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
| Test Method (Characteristic) | Acceptance Criteria | Reported Device Performance (Results) |
|---|---|---|
| Physical Properties (ASTM D6319-19) | ||
| Length | 220mm minimum for size XS and S; 230mm minimum for size M, L, XL and XXL | Pass |
| Width | XS: 70 ± 10 mm; S: 80 ± 10 mm; M: 95 ± 10 mm; L: 110 ± 10 mm; XL: 120 ± 10 mm; XXL: 130 ± 10 mm | Pass |
| Thickness (Palm & Finger) | Palm: 0.05 mm min for all sizes; Finger: 0.05 mm min for all sizes | Pass |
| Tensile Strength (Before Ageing) | 14MPa min for all sizes | Pass |
| Tensile Strength (After Ageing) | 14MPa min for all sizes | Pass |
| Ultimate Elongation (Before Ageing) | 500% min for all sizes | Pass |
| Ultimate Elongation (After Ageing) | 400% min for all sizes | Pass |
| Freedom from Holes (ASTM D5151-19) | G-I, AQL 2.5 | Pass |
| Powder Free Residue (ASTM D6124-06) | ≤ 2 mg/glove | Pass |
| Resistance to Permeation by Chemotherapy Drugs (ASTM D6978-05) | ||
| Bleomycin Sulfate (15 mg/ml) | >240 Minutes | >240 Minutes |
| Busulfan (6 mg/ml) | >240 Minutes | >240 Minutes |
| Carboplatin (10 mg/ml) | >240 Minutes | >240 Minutes |
| Carmustine (3.3 mg/ml) | 33.8 Minutes (Predicate) | 26.3 Minutes (Subject Device - Note: This value is lower than the predicate's reported value, but both are below 240 mins and thus subject to warning. The specific acceptance criteria for "low permeation" drugs is that they are identified and warned against.) |
| Cisplatin (1 mg/ml) | >240 Minutes | >240 Minutes |
| Cyclophosphamide (20 mg/ml) | >240 Minutes | >240 Minutes |
| Cytarabine (100 mg/ml) | >240 Minutes | >240 Minutes |
| Dacarbazine (10 mg/ml) | >240 Minutes | >240 Minutes |
| Daunorubicin HCl (5 mg/ml) | >240 Minutes | >240 Minutes |
| Docetaxel (10 mg/ml) | >240 Minutes | >240 Minutes |
| Doxorubicin HCl (2 mg/ml) | >240 Minutes | >240 Minutes |
| Epirubicin HCl (2 mg/ml) | >240 Minutes | >240 Minutes |
| Etoposide (20 mg/ml) | >240 Minutes | >240 Minutes |
| Fludarabine (25 mg/ml) | >240 Minutes | >240 Minutes |
| Fluorouracil (50 mg/ml) | >240 Minutes | >240 Minutes |
| Gemcitabine (38 mg/ml) | >240 Minutes | >240 Minutes |
| Idarubicin HCl (1 mg/ml) | >240 Minutes | >240 Minutes |
| Ifosfamide (50 mg/ml) | >240 Minutes | >240 Minutes |
| Irinotecan (20 mg/ml) | >240 Minutes | >240 Minutes |
| Mechlorethamine HCl (1 mg/ml) | >240 Minutes | >240 Minutes |
| Melphalan (5 mg/ml) | >240 Minutes | >240 Minutes |
| Methotrexate (25 mg/ml) | >240 Minutes | >240 Minutes |
| Mitomycin C (0.5 mg/ml) | >240 Minutes | >240 Minutes |
| Mitoxantrone HCl (2 mg/ml) | >240 Minutes | >240 Minutes |
| Paclitaxel (6 mg/ml) | >240 Minutes | >240 Minutes |
| Rituximab (10 mg/ml) | >240 Minutes | >240 Minutes |
| Thiotepa (10 mg/ml) | 128.1 Minutes (Predicate) | 49.1 Minutes (Subject Device - Note: This value is lower than the predicate's reported value, but both are below 240 mins and thus subject to warning. The specific acceptance criteria for "low permeation" drugs is that they are identified and warned against.) |
| Trisenox (1 mg/ml) | >240 Minutes | >240 Minutes |
| Vincristine Sulfate (1 mg/ml) | >240 Minutes | >240 Minutes |
| Resistance to Permeation by Opioid Drugs (ASTM D6978-05) | ||
| Fentanyl Citrate Injection (100mcg/2mL) | >240 Minutes | >240 Minutes |
| Biocompatibility (ISO 10993-23: Irritation) | Under the condition of study, not an irritant | Under the conditions of the study, the test article met the requirements of the test. |
| Biocompatibility (ISO 10993-10: Dermal Sensitization) | Under the conditions of the study, not a sensitizer | Under the conditions of the study, the test article was not considered a sensitizer. |
| Biocompatibility (ISO 10993-11: Acute Systemic Toxicity) | Under the conditions of study, the device extracts do not pose an acute systemic toxicity concern | Under the conditions of study, there was no mortality or evidence of acute systemic toxicity. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document lists "Bench Data" and "Biocompatibility Data" for the non-clinical tests. For these types of tests, specific sample sizes beyond what's typically required by the ASTM or ISO standards are not detailed in this summary. The data provenance is not specified, but these are standard laboratory tests. It is implied these are prospective tests conducted on the subject device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This section is Not Applicable (N/A). The device is a medical glove, and the evaluation relies on established standardized physical, chemical permeation, and biocompatibility tests, not subjective expert assessment of images or clinical outcomes that would require ground truth establishment by human experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This section is Not Applicable (N/A). Adjudication methods like 2+1 or 3+1 are used for resolving disagreements in expert assessments (e.g., in medical image interpretation). The tests performed are objective, standardized laboratory tests.
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 section is Not Applicable (N/A). This device is a medical glove, not an AI-assisted diagnostic tool. Therefore, MRMC studies and AI assistance are irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This section is Not Applicable (N/A). This device is a medical glove, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the performance of the gloves is established by objective measurements against the specified ASTM and ISO standards. For instance:
- Physical properties (length, width, thickness, tensile strength, elongation) are measured directly.
- Freedom from holes is determined by leakage tests per ASTM D5151-19.
- Powder residue is measured per ASTM D6124-06.
- Resistance to permeation by chemotherapy and opioid drugs is determined by measuring breakthrough time according to ASTM D6978-05.
- Biocompatibility is assessed through standardized biological tests (irritation, sensitization, systemic toxicity) as per ISO 10993 series.
8. The sample size for the training set
This section is Not Applicable (N/A). The device is a physical product (medical glove) and does not involve machine learning models that require training sets.
9. How the ground truth for the training set was established
This section is Not Applicable (N/A), as it refers to a training set for machine learning, which is irrelevant for this medical device.
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(32 days)
Nephron Nitrile™. Nitrile Powder-Free Examination Blue Gloves (Tested For Use With Chemotherapy Drugs and Fentanyl) is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. In addition, these gloves were tested for use with chemotherapy drugs and fentanyl in accordance with ASTM D6978-05 (2019) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.
The following chemotherapy drugs and concentration had NO breakthrough detected up to 240 minutes: Bleomycin Sulfate (15.0 mg/ml) Busulfan (6.0 mg/ml) Carboplatin (10.0 mg/ml) Cisplatin (1.0 mg/ml) Cyclophosphamide (20.0 mg/ml) Cytarabine (100.0 mg/ml) Dacarbazine (10.0 mg/ml) Daunorubicin HCl (5.0 mg/ml) Docetaxel (10.0 mg/ml) Doxorubicin HCl (2.0 mg/ml) Epirubicin HCl (2.0 mg/ml) Etoposide (20.0 mg/ml) Fludarabine (25.0 mg/ml) Fluorouracil (50.0 mg/ml) Gemcitabine (38.0 mg/ml) Idarubicin HCl (1.0 mg/ml) Ifosfamide (50.0 mg/ml) Irinotecan (20.0 mg/ml) Mechlorethamine HCl (1.0 mg/ml) Melphalan (5.0 mg/ml) Methotrexate (25.0 mg/ml) Mitomycin C (0.5 mg/ml) Mitoxantrone HCl (2.0 mg/ml) Paclitaxel (6.0 mg/ml) Rituximab (10.0 mg/ml) Trisenox (1.0 mg/ml) Vincristine Sulfate (1.0 mg/ml) The following chemotherapy drugs have low permeation times: Carmustine (3.3 mg/ml) : 33.8 minutes Thiotepa (10.0 mg/ml) : 128.1 minutes Warning: Not for Use with: Carmustine, Thiotepa The tested Opioid is: Fentanyl Citrate Injection (100 mcg/2 mL)
Nephron Nitrile™. Nitrile Powder-Free Examination Blue Gloves (Tested For Use With Chemotherapy Drugs and Fentanyl) are Class I patient examination gloves, bearing the product codes LZA, LZC, OPJ, QDO (21 CFR 880.6250). They meet all the current specifications listed under the ASTM D6319-19, Standard Specification for Nitrile Examination Gloves for Medical Application and also complies with requirements for Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs as per ASTM D6978-05 (2019). The powder-free gloves are made from Nitrile (NBR) latex and are blue in color. The product is non-sterile, fingertip textured, ambidextrous with beaded cuff, and single use only.
Nephron Nitrile™, Nitrile Powder-Free Examination Blue Gloves (Tested For Use With Chemotherapy Drugs and Fentanyl) include glove sizes: X-Small, Small, Medium, Large, X-Large and XX-Large.
This document describes the non-clinical testing performed for the Nephron Nitrile™ Nitrile Powder-Free Examination Blue Gloves to meet performance and safety criteria.
1. Table of Acceptance Criteria and Reported Device Performance:
| Test Method | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| ASTM D6319-19 (Nitrile Examination Gloves for Medical Application) | Length of the gloves | Extra-Small: 220 mm min; Small: 220 mm min; Medium: 230 mm min; Large: 230 mm min; X-Large: 230 mm min; XX-Large: 230 mm min | Extra-Small: 242 mm; Small: 243 mm; Medium: 235 mm; Large: 237 mm; X-Large: 250 mm; XX-Large: 238 mm |
| Width of the gloves | XS: 70±10 mm; S: 80±10 mm; M: 95±10 mm; L: 110±10 mm; XL: 120±10 mm; XXL: 130±10 mm | Extra-Small: 74 mm; Small: 85 mm; Medium: 95 mm; Large: 113 mm; X-Large: 121 mm; XX-Large: 129 mm | |
| Thickness of the gloves | Palm: 0.05 mm min for all sizes; Finger: 0.05 mm min for all sizes | Extra-Small: Palm 0.112 mm, Finger 0.145 mm; Small: Palm 0.095 mm, Finger 0.115 mm; Medium: Palm 0.077 mm, Finger 0.111 mm; Large: Palm 0.106 mm, Finger 0.109 mm; X-Large: Palm 0.089 mm, Finger 0.115 mm; XX-Large: Palm 0.113 mm, Finger 0.107 mm | |
| Physical properties - Tensile strength (Before aging) | 14MPa min for all sizes | Extra-Small: 33.74MPa; Small: 32.35MPa; (Medium, Large, X-Large, XX-Large results are the same as predicate and meet criteria) | |
| Physical properties - Tensile strength (After aging) | 14MPa min for all sizes | Extra-Small: 35.99MPa; Small: 32.14MPa; (Medium, Large, X-Large, XX-Large results are the same as predicate and meet criteria) | |
| Physical properties - Ultimate Elongation (Before aging) | 500% min for all sizes | Extra-Small: 565%; Small: 538%; (Medium, Large, X-Large, XX-Large results are the same as predicate and meet criteria) | |
| Physical properties - Ultimate Elongation (After aging) | 400% min for all sizes | Extra-Small: 514%; Small: 435%; (Medium, Large, X-Large, XX-Large results are the same as predicate and meet criteria) | |
| ASTM D5151-19 (Detection of Holes in Medical Gloves) | Holes in the gloves | AQL 2.5 | Gloves Pass AQL 2.5 |
| ASTM D6124-06 (Reapproved 2017) (Residual Powder on Medical Gloves) | Residual powder in the gloves | ≤ 2 mg/glove | Extra-Small: 0.822 mg/glove; Small: 0.147 mg/glove; (Medium, Large, X-Large, XX-Large results are the same as predicate and meet criteria) |
| ASTM D6978-05 (Reapproved 2019) (Permeation by Chemotherapy Drugs) | Breakthrough detection time of chemotherapy drugs | Bleomycin Sulfate (15 mg/ml) >240 Minutes; Busulfan (6 mg/ml) >240 Minutes; Carboplatin (10 mg/ml) >240 Minutes; Cisplatin (1 mg/ml) >240 Minutes; Cyclophosphamide (20 mg/ml) >240 Minutes; Cytarabine (100 mg/ml) >240 Minutes; Dacarbazine (10 mg/ml) >240 Minutes; Daunorubicin HCl (5 mg/ml) >240 Minutes; Docetaxel (10 mg/ml) >240 Minutes; Doxorubicin HCl (2 mg/ml) >240 Minutes; Epirubicin HCl (2 mg/ml) >240 Minutes; Etoposide (20 mg/ml) >240 Minutes; Fludarabine (25 mg/ml) >240 Minutes; Fluorouracil (50 mg/ml) >240 Minutes; Gemcitabine (38 mg/ml) >240 Minutes; Idarubicin HCl (1 mg/ml) >240 Minutes; Ifosfamide (50 mg/ml) >240 Minutes; Irinotecan (20 mg/ml) >240 Minutes; Mechlorethamine HCl (1 mg/ml) >240 Minutes; Melphalan (5 mg/ml) >240 Minutes; Methotrexate (25 mg/ml) >240 Minutes; Mitomycin C (0.5 mg/ml) >240 Minutes; Mitoxantrone HCl (2 mg/ml) >240 Minutes; Paclitaxel (6 mg/ml) >240 Minutes; Rituximab (10 mg/ml) >240 Minutes; Thiotepa (10 mg/ml) >240 Minutes (Note: Product warning for Carmustine and Thiotepa based on previous data indicated low permeation times); Trisenox (1 mg/ml) >240 Minutes; Vincristine Sulfate (1 mg/ml) >240 Minutes | All listed chemotherapy drugs met the acceptance criteria of >240 minutes for breakthrough detection, except Carmustine (33.8 mins) and Thiotepa (128.1 mins) for which there is a warning (results are identical to the predicate). |
| Breakthrough detection time of Opioid drugs | Fentanyl Citrate Injection (100mcg/2mL) >240 Minutes | Fentanyl Citrate Injection (100mcg/2mL) >240 Minutes (results are identical to the predicate) | |
| ISO 10993-23 (Tests for Irritation) | Local dermal irritation of a test article extract | Under the condition of study not an irritant | Under the conditions of the study, the test article met the requirements of the test. |
| ISO 10993-10 (Tests for Skin Sensitization) | Skin sensitization in Guinea pigs by maximization test | Under the conditions of the study, not a sensitizer | Under the conditions of the study, the test article was not considered a sensitizer. |
| ISO 10993-5 (Tests for In Vitro Cytotoxicity) | Potential of a test article to cause cytotoxicity | Under the conditions of the study, non-cytotoxic | The undiluted test articles extract and 50% test article extract dilution did not meet the requirements of the test and the 25%, 12.5%, 6.25%, and 3.13% test article extract dilutions met the requirements of the test. Cytotoxicity concern was addressed by acute systemic toxicity testing. |
| ISO 10993-11 (Tests for Systemic Toxicity) | Acute systemic toxicity of a test article, extract following injection | Under the conditions of study, the device extracts do not pose a systemic toxicity concern | Under the conditions of study, there was no mortality or evidence of systemic toxicity. |
2. Sample size used for the test set and the data provenance:
The document explicitly states "The results for Medium, Large, X-Large and XX-Large are the same as the predicate," indicating that for these sizes, existing data from the previous 510(k) submission (K231349) were leveraged. New testing was conducted for the added "Extra-Small" and "Small" sizes.
- Extra-Small and Small Sizes: Specific values are provided for these sizes, indicating new testing was performed for them. The document does not specify the exact number of gloves or samples tested for each physical property (length, width, thickness, tensile strength, ultimate elongation, residual powder, holes) for these new sizes, nor the number of replicates for the chemotherapy drug and opioid permeation tests for the subject device. However, these tests would typically follow the methodologies outlined in the referenced ASTM and ISO standards, which define appropriate sample sizes and testing protocols.
- Medium, Large, X-Large, and XX-Large Sizes: For these sizes, the results are stated to be "the same as the predicate," which implies that the data provenance for these sizes is from the previous 510(k) submission (K231349), and likely involved testing conducted per the same ASTM and ISO standards.
The document does not provide information on the country of origin of the data or whether it was retrospective or prospective, beyond indicating that newly generated data for XS and S sizes would be prospective for this submission, while data for other sizes are effectively retrospective from the predicate device.
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 to the type of device and testing performed. The "ground truth" here is defined by objective, standardized measurements against established ASTM and ISO performance criteria for medical gloves and their resistance to chemicals, not by expert interpretation of images or clinical outcomes.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not applicable. Adjudication methods are typically used in clinical or imaging studies where subjective expert review is involved. The tests for medical gloves are objective and rely on physical measurements and chemical analysis conforming to recognized standards.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
This information is not applicable. MRMC studies are relevant for AI/ML-enabled diagnostic devices that rely on human-in-the-loop interpretation. The device in question is a medical glove, which is a physical barrier device, not a diagnostic tool assisted by AI/ML.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not applicable, as it pertains to AI/ML software performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for the performance of these medical gloves is based on:
- Standardized Physical and Chemical Measurements: This includes quantitative measurements like length, width, thickness, tensile strength, ultimate elongation, residual powder, and breakthrough detection times for chemicals.
- Compliance with Recognized Standards: The acceptance criteria themselves are derived from established industry standards such as ASTM D6319-19, ASTM D5151-19, ASTM D6124-06 (Reapproved 2017), ASTM D6978-05 (Reapproved 2019), and ISO 10993 series for biocompatibility.
8. The sample size for the training set:
This information is not applicable. The device is a physical product (medical glove), and its performance is evaluated through non-clinical bench testing against established standards, not through training and testing of an AI/ML algorithm.
9. How the ground truth for the training set was established:
This information is not applicable, as there is no "training set" in the context of this device's non-clinical evaluation.
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(28 days)
Nephron Nitrile Powder-Free Nitrile Examination Gloves (Tested For Use With Chemotherapy Drugs and Fentanyl) is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. In addition, these gloves were tested for use with Chemotherapy drugs and Fentanyl in accordance with ASTM D6978-05 (2019) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.
Nephron Nitrile Powder-Free Nitrile Examination Gloves (Tested For Use With Chemotherapy Drugs and Fentanyl) is a Class I patient examination gloves bearing the product codes LZA, LZC, OPJ, QDO (21 CFR 880.6250). They meet all the current specifications listed under the ASTM D6319-19. Standard Specification for Nitrile Examination Gloves for Medical Application and also complies with requirements for Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs as per ASTM D6978-05 (2019). They are made from Nitrile (NBR). These gloves are blue in color and are powder free. The product is non-sterile, fingertip textured, ambidextrous with beaded cuff and single use only.
This document is a 510(k) Premarket Notification from the FDA for medical gloves, specifically "Nephron Nitrile Powder-Free Nitrile Examination Gloves (Tested For Use With Chemotherapy Drugs and Fentanyl)". It details the device's technical characteristics, indications for use, and a comparison to a predicate device, along with non-clinical testing results to demonstrate substantial equivalence.
Here's an analysis based on your request, focusing on the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and the Reported Device Performance
The acceptance criteria and performance data are primarily described in the "NON-CLINICAL TESTING SUMMARY PERFORMANCE DATA" and "BIOCOMPATIBILITY DATA" sections (pages 9-12).
| Test Method (Standard) | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| ASTM D6319-19 (Dimensions - Length) | To determine the length of the gloves | Medium: 230 mm min; Large: 230 mm min; X-Large: 230 mm min; XX-Large: 230 mm min | Medium: 235 mm; Large: 237 mm; X-Large: 250 mm; XX-Large: 238 mm |
| ASTM D6319-19 (Dimensions - Width) | To determine the width of the gloves | Medium: 95+/-10 mm; Large: 110+/-10 mm; X-Large: 120+/-10 mm; XX-Large: 130+/-10 mm | Medium: 95; Large: 113; X-Large: 121; XX-Large: 129 |
| ASTM D6319-19 (Thickness) | To determine the thickness of the gloves | Palm: 0.05 mm min for all sizes; Finger: 0.05 mm min for all sizes | Medium: Palm 0.077 mm, Finger 0.111 mm; Large: Palm 0.106 mm, Finger 0.109 mm; X-Large: Palm 0.089 mm, Finger 0.115 mm; XX-Large: Palm 0.113 mm, Finger 0.107 mm |
| ASTM D6319-19 (Physical Properties - Tensile Strength) | To determine the physical properties - Tensile strength | Before Ageing: 14MPa min for all sizes; After Ageing: 14MPa min for all sizes | Medium: Before Ageing 34.0 MPa, After Ageing 37.3 MPa (Only Medium size result provided, table formatting appears to omit others) |
| ASTM D6319-19 (Physical Properties - Ultimate Elongation) | To determine the physical properties - Ultimate Elongation | Before Ageing: 500% min for all sizes; After Ageing: 400% min for all sizes | Medium: Before Ageing 542%, After Ageing 503% (Only Medium size result provided, table formatting appears to omit others) |
| ASTM D5151-19 | To determine the holes in the gloves | AQL 2.5 | Gloves Pass AQL 2.5 |
| ASTM D6124-06 (Reapproved 2017) | To determine the residual powder in the gloves | ≤ 2 mg/glove | Medium: 0.3516 mg/glove (Only Medium size result provided, table formatting appears to omit others) |
| ASTM D6978-05 (Reapproved 2019) (Chemotherapy Drugs) | To determine the breakthrough detection time of chemotherapy drugs | Generally ">240 Minutes" for most listed drugs (e.g., Bleomycin Sulfate 15mg/ml >240 Minutes, Busulfan 6 mg/ml >240 Minutes, Carboplatin 10 mg/ml >240 Minutes, etc.) With specific lower times for Carmustine (33.8 mins) and Thiotepa (128.1 mins), and a "Warning: Not for Use with: Carmustine, Thiotepa" based on these low permeation times. | Results matched acceptance criteria: ">240 Minutes" for the majority of listed drugs, and the specified lower times for Carmustine (33.8 mins) and Thiotepa (128.1 mins) were reported. |
| ASTM D6978-05 (Reapproved 2019) (Opioid Drugs) | To determine the breakthrough detection time of Opioid drugs | Fentanyl Citrate Injection (100mcg/2mL) >240 Minutes | Fentanyl Citrate Injection (100mcg/2mL) >240 Minutes |
| ISO 10993-23 First edition 2021-01 (Irritation) | To evaluate the local dermal irritation of a test article extract | Under the condition of study not an irritant | Under the conditions of the study, the test article met the requirements of the test. |
| ISO 10993-10 Fourth edition 2021-11 (Skin Sensitization) | To evaluate the test item for skin sensitization | Under the conditions of the study, not a sensitizer | Under the conditions of the study, the test article was not considered a sensitizer. |
| ISO 10993-5 Third edition 2009-06-01 (In Vitro Cytotoxicity) | To determine the potential of a test article to cause cytotoxicity | Under the conditions of the study, non-cytotoxic | The undiluted test article extract and 50% test article extract dilution did not meet the requirements of the test and the 25%, 12.5%, 6.25%, and 3.13% test article extract dilutions met the requirements of the test. Cytotoxicity concern was addressed by acute systemic toxicity testing. (Note: This result indicates that higher concentrations were not non-cytotoxic, but the justification points to systemic toxicity testing to mitigate this concern.) |
| ISO 10993-11 Third edition 2017-09 (Acute Systemic Toxicity) | To evaluate the acute systemic toxicity of a test article extract | Under the conditions of study, the device extracts do not pose a systemic toxicity concern | Under the conditions of study, there was no mortality or evidence of systemic toxicity. |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not explicitly state the exact sample sizes used for each specific test (e.g., number of gloves tested for permeation, dimensions, etc.) beyond what's implied by the AQL 2.5 for freedom from holes (which dictates the sampling plan based on lot size, but the lot size isn't provided).
- Data Provenance: The studies were non-clinical bench tests and biocompatibility tests performed to established ASTM and ISO standards. The location where these tests were conducted is not specified in this FDA letter, but typically these are performed in certified laboratories. The data is prospective, in the sense that the tests were conducted specifically to demonstrate the performance of the device for this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This document describes a 510(k) submission for an examination glove, which is a Class I medical device. The "ground truth" for these tests are established by widely accepted international and national standards (ASTM and ISO). These standards themselves are developed by committees of experts in relevant fields (materials science, chemistry, toxicology, medical device manufacturing, etc.), and the laboratories performing the tests follow strict protocols defined by these standards.
The document does not mention the use of individual human experts (like radiologists for imaging studies) to establish "ground truth" for the performance or safety of the glove itself in the way that would apply to, for example, an AI diagnostic aid. The "ground truth" for the glove's performance is derived directly from the application of the specified physical, chemical, and biological test methods.
4. Adjudication Method for the Test Set
Not applicable in the context of this device and testing. Adjudication methods (like 2+1, 3+1 consensus) are relevant for subjective expert review processes, such as interpreting medical images or clinical outcomes. For the physical and chemical property tests of a glove, the results are quantitative measurements or pass/fail criteria against a defined standard, not subject to human interpretation discrepancies requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No. An MRMC study is relevant for AI-powered diagnostic devices where human readers (e.g., radiologists) perform tasks with and without AI assistance to measure the AI's impact on human performance. This document pertains to a physical medical device (examination glove), not an AI diagnostic system.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is a glove, not an algorithm. The performance tests are "standalone" in the sense that they measure the intrinsic properties of the glove itself.
7. The Type of Ground Truth Used
The ground truth for this device is based on defined physical, chemical, and biological performance standards and test methodologies (e.g., ASTM D6319-19 for glove properties, ASTM D6978-05 for chemical permeation resistance, ISO 10993 series for biocompatibility). These standards specify the methods for measuring parameters like tensile strength, freedom from holes, chemical breakthrough time, and biological responses (irritation, sensitization, cytotoxicity, systemic toxicity).
8. The Sample Size for the Training Set
Not applicable. This document is about a physical medical device (glove), not a machine learning or AI model. Therefore, there is no "training set."
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set for this type of medical device submission.
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