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510(k) Data Aggregation
(197 days)
KGO
The Sterile Powder Free Synthetic Rubber Surgeon's Gloves, Green Color, Tested For Use With Chemotherapy Drugs and Gastric Acid is a single use disposable device intended to be worn by operating room personnel to protect a surgical wound from contamination.
The tested drugs are:
| Compound | Minimum Breakthrough Time (minutes) |
|---|---|
| Carmustine (BCNU) (3.3 mg/ml) | 15.8 |
| Cyclophosphamide (20 mg/ml) | >240 |
| Doxorubicin (2 mg/ml) | >240 |
| Etoposide (Toposar) (20 mg/ml) | >240 |
| Fluorouracil (50 mg/ml) | >240 |
| Paclitaxel (6 mg/ml) | >240 |
| Thiotepa (THT) (10 mg/ml) | 24.6 |
| Bleomycin sulfate (15 mg/ml) | >240 |
| Carboplatin (10 mg/ml) | >240 |
| Cisplatin (1 mg/ml) | >240 |
| Cytarabine (100 mg/ml) | >240 |
| Dacarbazine (10 mg/ml) | >240 |
| Daunorubicin HCl (5 mg/ml) | >240 |
| Docetaxel (10 mg/ml) | >240 |
| Gemcitabine HCl (38 mg/ml) | >240 |
| Idarubicin HCl (1 mg/ml) | >240 |
| Ifosfamide (50 mg/ml) | >240 |
| Irinotecan HCl (20 mg/ml) | >240 |
| Mechlorethamine HCl (1 mg/ml) | >240 |
| Melphalan HCl (5 mg/ml) | >240 |
| Methotrexate (25 mg/ml) | >240 |
| Mitomycin C (0.5 mg/ml) | >240 |
| Mitoxantrone (2 mg/ml) | >240 |
| Vincristine Sulfate (1 mg/ml) | >240 |
| Busulfan (6 mg/ml) | >240 |
| Chloroquine (50 mg/ml) | >240 |
| Cyclosporin A (100 mg/ml) | >240 |
| Epirubicin HCl (2 mg/ml) | >240 |
| Fludarabine Phosphate (25 mg/ml) | >240 |
| Oxaliplatin (2 mg/ml) | >240 |
| Retrovir (10 mg/ml) | >240 |
| Rituximab (10 mg/ml) | >240 |
| Topotecan HCl (1 mg/ml) | >240 |
| Trisenox (Arsenic Trioxide) (1 mg/ml) | >240 |
| Velcade (Bortezomib) (1 mg/ml) | >240 |
Simulated Gastric Acid Fluid was also tested with a minimum breakthrough greater than 240 minutes.
Sterile Powder Free Synthetic Rubber Surgeon's Gloves, Green Color, Tested For Use With Chemotherapy Drugs and Gastric Acid is a sterile and disposable device. This glove is made of synthetic polyisoprene rubber inside coated with synthetic material to ease donning the glove. The device is intended to be worn on hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants. These gloves were tested for use with Chemotherapy Drugs and Gastric Acid as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
The device conforms to the following FDA recognized consensus standards: ASTM D3577-19, ASTM D6124-06, ASTM D5151-19, ASTM D412-16, ISO 11137-1:2006 + AMD1:2013 + AMD2:2018, ISO 11137-2:2013 + AMD1:2022, and ASTM D6978-05.
Sterile Powder Free Synthetic Rubber Surgeon's Gloves, Green Color, Tested For Use With Chemotherapy Drugs and Gastric Acid is available in the following sizes: 5.5, 6.0, 6.5, 7.0, 7.5, 8.0, 8.5, and 9.0.
The provided document is a 510(k) clearance letter from the FDA for a medical device: "Sterile Powder Free Synthetic Rubber Surgeon's Gloves, Green Color, Tested For Use With Chemotherapy Drugs and Gastric Acid." This document outlines the general requirements for the device and details the non-clinical testing performed to establish substantial equivalence to a predicate device.
However, it does not contain any information regarding clinical studies, AI/ML device performance, or human-in-the-loop studies. The device is a physical medical glove and not an AI-powered diagnostic or assistive tool. Therefore, the requested information elements related to AI/ML and clinical study methodologies are not applicable to this submission.
The document focuses on demonstrating the physical, chemical, and biological safety and performance of the gloves according to recognized consensus standards.
Here's the relevant information that can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance
The device underwent non-clinical testing against several recognized standards. The "Results" column consistently states "PASS," indicating that the device met the specified acceptance criteria for each test.
| Title of Test | Purpose of Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| ASTM D3577-19 | Dimensions | Meets criteria in accordance with ASTM D3577-19: Standard Specification for Rubber Surgical Gloves | PASS |
| ASTM D3577-19 | Physical Properties | Meets criteria for tensile strength, ultimate elongation and stress at 500% elongation before and after accelerated aging for synthetic surgical gloves per ASTM D3577-19: Standard Specification for Rubber Surgical Gloves | PASS |
| ASTM D5151-19 | Freedom from holes | Meets criteria in accordance with ASTM D3577-19: Standard Specification for Rubber Surgical Gloves with AQL requirements of 0.65 | PASS |
| ASTM D6124 | Powder-Free | Meets applicable acceptance criteria for powder free ≤ 2mg per glove per ASTM D3577-19: Standard Specification for Rubber Surgical Gloves | PASS |
| ISO 11137-1:2006 | Sterility | Meets acceptance criteria requirement of 10⁻⁶ SAL per ISO 11137-1: Sterilization for health care products – Radiation – Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices | PASS |
| ASTM D6978-05 | Chemotherapy Drug Permeation Test | Testing performed in accordance with ASTM D6978-05: Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs. | PASS |
| ISO 10993-10:2010 | Biocompatibility: Skin Irritation | Passes Primary Skin Irritation test per ISO 10993-10, Biological Evaluation of medical devices, Part 10: Test for irritation and skin sensitization. Under the conditions of the study, not an irritant. | PASS |
| ISO 10993-10:2010 | Biocompatibility: Dermal Sensitization | Passes Dermal Sensitization test per ISO 10993-10, Biological Evaluation of medical devices, Part 10: Test for irritation and skin sensitization. Under the conditions of the study, not a sensitizer. | PASS |
| ISO 10993-11:2017 | Biocompatibility: Acute Systemic Toxicity | Passes Acute Systemic Toxicity Test per ISO 10993-11, Biological Evaluation of medical devices, Part 11: Test for systemic toxicity. Under the conditions of the study, there was no mortality or evidence of acute systemic toxicity. | PASS |
| ISO 10993-11:2017 | Biocompatibility: Material-Mediated Pyrogenicity | Passes Material-Mediated Pyrogenicity Test per ISO 10993-11, Biological Evaluation of medical devices, Part 11: Test for systemic toxicity. Under the conditions of the study, no pyrogenic response was observed. | PASS |
| USP | Endotoxin Testing | Meets acceptance criteria for bacterial endotoxins per USP Bacterial Endotoxins Test. Endotoxin level ≤ 20 EU/device. | PASS |
Chemotherapy Drug Permeation Results:
| Compound | Minimum Breakthrough Time (minutes) |
|---|---|
| Carmustine (BCNU) (3.3 mg/ml) | 15.8 |
| Cyclophosphamide (20 mg/ml) | >240 |
| Doxorubicin (2 mg/ml) | >240 |
| Etoposide (Toposar) (20 mg/ml) | >240 |
| Fluorouracil (50 mg/ml) | >240 |
| Paclitaxel (6 mg/ml) | >240 |
| Thiotepa (THT) (10 mg/ml) | 24.6 |
| Bleomycin sulfate (15 mg/ml) | >240 |
| Carboplatin (10 mg/ml) | >240 |
| Cisplatin (1 mg/ml) | >240 |
| Cytarabine (100 mg/ml) | >240 |
| Dacarbazine (10 mg/ml) | >240 |
| Daunorubicin HCl (5 mg/ml) | >240 |
| Docetaxel (10 mg/ml) | >240 |
| Gemcitabine HCl (38 mg/ml) | >240 |
| Idarubicin HCl (1 mg/ml) | >240 |
| Ifosfamide (50 mg/ml) | >240 |
| Irinotecan HCl (20 mg/ml) | >240 |
| Mechlorethamine HCl (1 mg/ml) | >240 |
| Melphalan HCl (5 mg/ml) | >240 |
| Methotrexate (25 mg/ml) | >240 |
| Mitomycin C (0.5 mg/ml) | >240 |
| Mitoxantrone (2 mg/ml) | >240 |
| Vincristine Sulfate (1 mg/ml) | >240 |
| Busulfan (6 mg/ml) | >240 |
| Chloroquine (50 mg/ml) | >240 |
| Cyclosporin A (100 mg/ml) | >240 |
| Epirubicin HCl (2 mg/ml) | >240 |
| Fludarabine Phosphate (25 mg/ml) | >240 |
| Oxaliplatin (2 mg/ml) | >240 |
| Retrovir (10 mg/ml) | >240 |
| Rituximab (10 mg/ml) | >240 |
| Topotecan HCl (1 mg/ml) | >240 |
| Trisenox (Arsenic Trioxide) (1 mg/ml) | >240 |
| Velcade (Bortezomib) (1 mg/ml) | >240 |
| Stomach Acid | >240 |
Warning: Carmustine: 15.8 minutes and Thiotepa: 24.6 minutes. Do not use with Carmustine and Thiotepa.
Summary of Study Information (Not Applicable for this Device Type)
The provided document describes a Class I medical device (Sterile Powder Free Synthetic Rubber Surgeon's Gloves) which is a physical product, not a software device or an AI/ML-driven system. Therefore, the following requested information points related to AI/ML device performance and clinical study methodologies are not applicable. The submission primarily relied on non-clinical (bench) testing to demonstrate substantial equivalence to a predicate device.
- Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable, as this is a physical device tested via non-clinical laboratory methods according to recognized standards (e.g., ASTM, ISO). The specific sample sizes for each non-clinical test (e.g., number of gloves for tensile strength, number of samples for permeation, number of animals for biocompatibility) are part of the detailed test reports but are not summarized in this FDA summary document. Data provenance details like country of origin for test materials or retrospective/prospective nature are not specified as they are not relevant for this type of non-clinical testing.
- 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): Not applicable. "Ground truth" in the context of expert consensus is typically relevant for diagnostic AI/ML devices interpreting medical images or other complex data. For gloves, "ground truth" is established by adherence to quantitative physical, chemical, and biological performance standards.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. Adjudication methods are used in clinical trials or expert review panels, not for standard physical/chemical testing of a device like a glove.
- 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 not an AI system nor does it involve human readers.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This device is not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For this device, the "ground truth" is adherence to the specified performance criteria defined by the listed consensus standards (e.g., ASTM D3577 for physical properties, ASTM D6978 for chemotherapy permeation, ISO 10993 for biocompatibility). These standards define acceptable quantitative limits or qualitative responses (e.g., "not an irritant").
- The sample size for the training set: Not applicable. This device does not involve a "training set" as it is not an AI/ML device.
- How the ground truth for the training set was established: Not applicable. This device does not involve a "training set."
Conclusion:
The FDA document K250313 confirms the clearance of sterile surgeon's gloves based on their adherence to established non-clinical performance and safety standards, including physical properties, sterility, and resistance to chemotherapy drugs and gastric acid. The document explicitly states that "[a] clinical study was not conducted in support of this submission." The questions related to AI/ML, clinical study designs, expert ground truth, and training data are not relevant to this specific device submission.
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(154 days)
KGO
The Polyisoprene Surgical Gloves are single use device intended to be worn on the hands of operating room personnel to protect a surgical wound from contamination. It is provided sterile.
Polyisoprene Surgical gloves
I am sorry, but the provided text from the FDA document (K240790) pertains to the clearance of "Polyisoprene Surgical gloves" and focuses entirely on regulatory information, such as:
- The FDA's decision regarding the 510(k) premarket notification.
- Classification of the device (Class I, reserved).
- Applicable regulations (e.g., 21 CFR 878.4460 for Non-Powdered Surgeon's Glove, Quality System regulation 21 CFR Part 820).
- Guidance on changes requiring new premarket notifications.
- Information on adverse event reporting and other regulatory compliance.
- The "Indications for Use" for the surgical gloves.
This document does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, ground truth establishment, or any details related to AI/algorithm-based medical devices. It is a regulatory clearance letter for a non-software/AI medical device.
Therefore, I cannot provide the requested information regarding acceptance criteria and study details based on the provided text.
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(259 days)
KGO
A powder-free sterile surgeon's glove is a disposable device made of natural rubber intended to be worn on the hands of healthcare personnel as a barrier for protection against cross-contamination between the healthcare personnel and patient.
These gloves were tested for use with Chemotherapy Drugs and Fentanyl Citrate as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
This is a disposable natural rubber surgical glove that is tested for use with chemotherapy drugs and fentanyl resistance. The glove is supplied in the following sizes: 5½, 6, 6½, 7, 7½, 8, 8½ and 9.
The provided document describes the acceptance criteria and study results for two types of Natural Rubber Latex Surgical Gloves:
- Natural Rubber Latex Surgical Glove, Powder Free, Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl (Green)
- Natural Rubber Latex (Strip&Coat)/(Strip&Pack) Surgical Glove, Powder Free, Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl
This is a 510(k) Premarket Notification submission, which aims to demonstrate that a new device is substantially equivalent to a legally marketed predicate device. The information provided focuses on the performance of the device against established standards (e.g., ASTM standards) rather than a clinical trial with human subjects or an AI-based study. As such, many of the requested points related to AI/MRMC studies, expert ground truth establishment, adjudication methods, and training/test set sample sizes for AI are not applicable to this type of device submission.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The "Summary of Non-Clinical Testing" (pages 15-16) and "Table 1" (pages 8-14) present the acceptance criteria and the device's performance.
Summary Table of Acceptance Criteria and Reported Device Performance
| Characteristic / Test Method | Standard(s) | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Physical Properties | ASTM D412 | ||
| Tensile Strength | - | Before Aging: Min. 24MPa; After Aging: Min. 18MPa | Before Aging: Pass; After Aging: Pass |
| Ultimate Elongation | - | Before Aging: Min. 750%; After Aging: Min. 560% | Before Aging: Pass; After Aging: Pass |
| Stress at 500% Elongation | - | Before Aging: Max. 5.5MPa; After Aging: N/A | Before Aging: Pass; After Aging: N/A |
| Dimension | ASTM D3767 | ||
| Length | Each size satisfies ASTM requirement | Length: Each size satisfies ASTM requirement | Pass (5½: Min. 245mm; 6.0-9.0: Min. 265mm for both devices) |
| Width | Each size satisfies ASTM requirement | Width: Each size satisfies ASTM requirement | Pass (e.g., 5½: 70 ± 6 mm; 9.0: 114 ± 6 mm for both devices) |
| Thickness | - | Finger: Min. 0.10 mm; Palm: Min. 0.10 mm; Cuff: Min. 0.10 mm | Pass |
| Watertight | ASTM D5151 | Freedom from holes at AQL 0.65 | Pass (Meets 21 CFR 800.20 and ASTM D3577 when tested in accordance with ASTM D5151 Inspection Level I, AQL 0.65) |
| Residual Powder | ASTM D6124 | Powder residue limit of ≤2.0 mg per glove | Pass |
| Protein Content | ASTM D5712 | ≤ 200 µg/dm2 | Pass |
| Biocompatibility | |||
| Primary Skin Irritation | ISO 10993-10 | Not a primary skin irritant | Not a primary skin irritation (Passes) |
| Dermal Sensitization | ISO 10993-10 | Not a contact sensitizer | Not a contact sensitizer (Passes) |
| Acute Systemic Toxicity | ISO 10993-11 | No biological reactivity shown | No biological reactivity shown (It is concluded that the devices did not induce any acute systemic toxicity) |
| Material Mediated Pyrogenicity | ISO 10993-11 | No increase of temperature (Non-pyrogenic) | No increase of temperature (It is concluded that the devices are non-pyrogenic) |
| Cytotoxicity - Direct Contact | ISO 10993-5 | Non-cytotoxic | Non-cytotoxic for S&C/S&P gloves |
| Cytotoxicity - MEM Elution | ISO 10993-5 | Non-cytotoxic | For Green gloves: Under the conditions of this study, the test article extract showed potential toxicity to L929 cells. For Strip&Coat/Strip&Pack gloves: Non-cytotoxic for S&C/S&P gloves (Note: This is a discrepancy with the table on page 16, which only shows the Green glove result for MEM Elution. However, the final conclusion states non-cytotoxic for S&C/S&P gloves in the direct contact test, implying potential difference in test methods or interpretation for the two types of gloves). |
| Bacterial Endotoxin | Limulus Amoebocyte Lysate (LAL) test | ≤20 EU/pair of gloves | Pass |
| Chemotherapy Drug Permeation | ASTM D6978-05 | Breakthrough Detection Time in Minutes: Generally >240 minutes | Green Glove: Most drugs >240 min. Exceptions: Carmustine (11.9 min), Thiotepa (14.7 min). Strip&Coat/Strip&Pack Glove: Most drugs >240 min. Exceptions: Carmustine (5.7 min), Thiotepa (13.8 min). WARNING labels are provided for Carmustine and Thiotepa. |
| Fentanyl Citrate Permeation | ASTM D6978-05 | Breakthrough Detection Time in Minutes: No breakthrough up to 240 minutes | No breakthrough up to 240 minutes (for both glove types). |
| Sterility Status | Medical Glove Guidance Manual - Labeling | Sterile | Sterile |
| Sterility Method | ISO 11137-1, ISO 11137-2 | Gamma Radiation (effective) | Gamma Radiation (Same as predicate) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not explicitly state the specific number of gloves (sample size) used for each physical, chemical, and biocompatibility test. It refers to compliance with ASTM standards, which typically specify minimum sample sizes for testing (e.g., ASTM D5151 for watertightness requires a specific inspection level and AQL, implying a certain sample size based on lot size). However, the exact sample numbers are not itemized here.
- Data Provenance: The tests are non-clinical (laboratory tests) performed on the manufactured gloves. The manufacturer is WRP Asia Pacific Sdn. Bhd., located in Malaysia (as per Section 1.0 Submitter). The data is generated from testing of the finished device. It is inherently "prospective" in the sense that the tests were conducted specifically for this submission, validating the device's properties.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not Applicable. This is a medical device submission based on a laboratory evaluation against recognized performance standards (ASTM, ISO, CFR). The "ground truth" for the device's physical and chemical properties is established by these objective, standardized test methods and their defined acceptance criteria, not by human expert interpretation or consensus as would be the case for an AI-enabled diagnostic device.
4. Adjudication Method for the Test Set
- Not Applicable. As the tests are objective, laboratory-based measurements (e.g., tensile strength, breakthrough time, watertightness), there is no need for expert adjudication. The results are quantitative and compared directly to predetermined numerical acceptance criteria.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No, a MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human interpretation (e.g., radiologists reading images) and the impact of AI assistance on that interpretation. This submission is for a physical barrier device (surgical gloves), not an AI-enabled diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is not an AI algorithm.
7. The Type of Ground Truth Used
- Ground Truth: The ground truth for this device is established by objective, standardized test methods and their defined acceptance criteria. These standards (e.g., ASTM D3577, ASTM D6978-05, ISO 10993 series) specify a methodology for testing and a quantitative or qualitative result that the device must meet (e.g., minimum tensile strength, maximum protein content, no breakthrough of chemicals). The chemical permeation results are based on the ASTM D6978-05 standard for chemotherapy drug permeation.
8. The Sample Size for the Training Set
- Not Applicable. There is no "training set" as this is not an AI/machine learning device. The glove is a manufactured product whose performance is evaluated against material and safety standards.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. Since there is no training set, this question is not relevant.
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(128 days)
KGO
The glove is intended to be worn by operating room personnel to protect a surgical wound from contamination. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978.
Sterile Powder Free Latex Surgical Gloves, Tested for Use with Chemotherapy Drugs is a disposable single-use, sterile, natural-colored and powder-free surgical glove made from rubber latex. They are in different sizes - 5.5, 6.0, 6.5, 7.0, 7.5, 8.0, 8.5, 9.0. Gloves meet the specification of ASTM D3577-19 and have been tested for resistance to permeation by chemotherapy drugs as per ASTM D6978-05(2019).
The provided text describes the acceptance criteria and the study that proves a medical device (Sterile Powder Free Latex Surgical Gloves, Tested for Use with Chemotherapy Drugs) meets those criteria.
Here's the breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The device's performance is primarily assessed against ASTM standards and biocompatibility tests. The table below summarizes these, focusing on the key performance characteristics relevant to general surgical gloves and their resistance to chemotherapy drugs.
| Acceptance Criteria / Performance Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Physical Properties (per ASTM D3577-19) | ||
| Length (size 5.5) | ≥ 245 mm | 283-308 mm |
| Length (size 6-9) | ≥ 265 mm | 283-308 mm |
| Palm Width (e.g., size 5.5, 6.0, etc.) | Specific ranges (e.g., 5.5: 70±6 mm, 6.0: 76±6 mm, etc.) | Average values within specified ranges (e.g., 5.5: 72 mm, 6.0: 76 mm) |
| Finger Thickness | Minimum 0.10 mm | 0.20-0.26 mm |
| Palm Thickness | Minimum 0.10 mm | 0.19-0.24 mm |
| Cuff Thickness | Minimum 0.10 mm | 0.16-0.19 mm |
| Tensile Strength, Before Aging | ≥ 24 MPa | Average 24-29 MPa |
| Ultimate Elongation, Before Aging | ≥ 750 % | Average 750-851% |
| Stress at 500% Elongation | ≤ 5.5 MPa | Average 2.1-4.5 MPa |
| Tensile Strength, After Accelerated Aging | ≥ 18 MPa | Average 18-25 MPa |
| Ultimate Elongation, After Accelerated Aging | ≥ 560 % | Average 610-796 % |
| Other Performance Metrics | ||
| Freedom from holes (per ASTM D3577-19, ASTM D 5151-19) | AQL 1.5 requirements | Meets AQL 1.5 |
| Powder-Free (per ASTM D3577-19, ASTM D6124-06 (2022)) | ≤ 2 mg per glove | 0.09-0.12 mg per glove |
| Aqueous Extractable Protein Content (per ASTM D3577-19, ASTM D5712-15) | ≤ 200 ug/dm² | 0.07-0.34 ug/dm² |
| Sterility Assurance Level | 10-6 SAL | 10-6 SAL |
| Chemotherapy Drug Permeation (per ASTM D6978-05 (2019)) | ||
| Bleomycin Sulfate 15mg/ml (15000 ppm) | Minimum Breakthrough Detection Time (BDT) based on predicate/reference devices (typically >240 minutes for most drugs, except Carmustine and Thiotepa) | >240 minutes |
| Busulfan 6mg/ml (6,000 ppm) | - | >240 minutes |
| Carboplatin 10mg/ml (10,000 ppm) | - | >240 minutes |
| Carmustine (BCNU)3.3 mg/ml (3,300 ppm) | Comparative to predicate/reference (e.g., predicate 13.2 min, reference 12.6 min) | 14.0 minutes (Note: Warning: Do not use with Carmustine) |
| Cisplatin 1mg/ml (1,000 ppm) | - | >240 minutes |
| Cyclophosphamide 20mg/ml (20,000 ppm) | - | >240 minutes |
| Cytarabine HCL, 100 mg/ml (100,000 ppm) | - | >240 minutes |
| Dacarbazine 10 mg/ml (10,000 ppm) | - | >240 minutes |
| Doxorubicin HCL, 2 mg/ml (2,000 ppm) | - | >240 minutes |
| Etoposide, 20 mg/ml (20,000 ppm) | - | >240 minutes |
| Epirubicin HCL, 2 mg/ml (2,000 ppm) | - | >240 minutes |
| Fludarabine, 25 mg/ml (25,000 ppm) | - | >240 minutes |
| Fluorouracil, 50mg/ml (50,000ppm) | - | >240 minutes |
| Idarubicin HCL, 1mg/ml (1,000ppm) | - | >240 minutes |
| Ifosfamide, 50mg/ml (50,000ppm) | - | >240 minutes |
| Mechlorethamine HCI, 1mg/ml (1,000ppm) | - | >240 minutes |
| Melphalan, 5mg/ml (5,000ppm) | - | >240 minutes |
| Methotrexate, 25mg/ml (25,000ppm) | - | >240 minutes |
| Mitomycin C, 0.5mg/ml (500ppm) | - | >240 minutes |
| Mitoxantrone HCL, 2mg/ml (2,000ppm) | - | >240 minutes |
| Paclitaxel, 6mg/ml (6,000ppm) | - | >240 minutes |
| Paraplatin, 10mg/ml (10,000ppm) | - | >240 minutes |
| Rituximab, 10mg/ml (10,000ppm) | - | >240 minutes |
| Thio Tepa, 10mg/ml (10,000ppm) | Comparative to predicate/reference (e.g., predicate 12.0 min, reference 22.4 min) | 16.1 minutes (Note: Warning: Do not use with Thiotepa) |
| Vincristine Sulfate, 1mg/ml (1,000ppm) | - | >240 minutes |
| Biocompatibility (per ISO 10993 series) | ||
| Skin Sensitization (ISO 10993-10) | No significant evidence of causing skin sensitization | No significant evidence of causing skin sensitization |
| Intracutaneous Reactivity (ISO 10993-23) | Polar and non-polar extract score less 1.0 | Test met requirements (score less 1.0) |
| Cytotoxicity (ISO 10993-5) | Acceptable level of cytotoxicity (comparison to predicate for "grade 2 at 1:16 dilution, grade 0 at 1:32 and 1:64 dilutions") | Showed potential toxicity to L929 cells (Note: This is presented as meeting the acceptance criteria by the submitter, implying it's acceptable for the device type) |
| Acute Systemic Toxicity (ISO 10993-11) | No evidence of acute systemic toxicity | No evidence of acute systemic toxicity |
| Material-mediated Pyrogenicity (ISO 10993-11) | No rabbit shows an individual rise in temperature of 0.5°C or more | Test met requirements (no rabbit showed individual rise in temperature of 0.5°C or more) |
| Endotoxin |
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(114 days)
KGO
Gammex PI Hybrid Micro Surgical Gloves are sterile, non-pyrogenic, are intended to be worn by operating room personnel to protect a surgical wound from contamination and have a shelf life of 3 years. These gloves were tested for use with Chemotherapy Drugs as per ASTM D6978 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. Tested chemotherapy drugs are as follows: Test chemotherapy drug and concentration Minimum breakthrough detection time in minutes Bleomycin (15.0 mg/ml) >240 Busulfan (6.0 mg/ml) >240 Carboplatin (10.0 mg/ml) >240 Carmustine (3.3 mg/ml) 24.1 Cisplatin (1.0 mg/ml) >240 Cyclophosphamide (20.0 mg/ml) >240 Cytarabine HCl (100.0 mg/ml) >240 Dacarbazine (10.0 mg/ml) >240 Daunorubicin HCl (5.0 mg/ml) >240 Docetaxel (10.0 mg/ml) >240 Doxorubicin HCl (2.0 mg/ml) >240 Epirubicin (2.0 mg/ml) >240 Etoposide (20.0 mg/ml) >240 Fludarabine (25.0 mg/ml) >240 Fluorouracil (50.0 mg/ml) >240 Gemcitabine (38.0 mg/ml) >240 Idarubicin (1.0 mg/ml) >240 Ifosfamide (50.0 mg/ml) >240 Irinotecan (20.0 mg/ml) >240 Mechlorethamine HCI (1.0 mg/ml) >240 Melphalan (5.0mg/ml) >240 Methotrexate (25.0 mg/ml) >240 Mitomycin C (0.5 mg/ml) >240 Mitoxantrone (2.0mg/ml) >240 Oxaliplatin (2.0 mg/ml) >240 Paclitaxel (6.0 mg/ml) >240 Rituximab (10.0 mg/ml) >240 ThioTEPA (10.0 mg/ml) 26.0 Vincristine Sulfate (1.0 mg/ml) >240 Warning: Do not use with Carmustine or ThioTEPA
Gammex PI Hybrid Micro Surgical Gloves are sterile and disposable devices. The gloves are made of a synthetic rubber polyisoprene and neoprene blend. Ansell has performed independent laboratory testing to support use with Chemotherapy Drugs and Non-Pyrogenic claims. The glove has a shelf life of 3 years, is brown in color and comes in the following sizes: 5.5, 6.0, 6.5, 7.0, 7.5, 8.0, 8.5, 9.0. Each size is assigned with a model number.
The document provides information on the non-clinical testing conducted for the GAMMEX PI Hybrid Micro surgical gloves. Here's a breakdown of the acceptance criteria and study details:
1. Table of Acceptance Criteria and Reported Device Performance:
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Dimensions (ASTM D3767-03) | In accordance with ASTM D3577-19: Standard Specification for Rubber Surgical Gloves. | PASS |
| Physical Properties (ASTM D3577-19) | Acceptance criteria for tensile strength, ultimate elongation and stress at 500% elongation before and after accelerated aging for synthetic surgical gloves per ASTM D3577-19. | PASS |
| Freedom from holes (ASTM D5151-19) | In accordance with ASTM D3577-19: Standard Specification for Rubber Surgical Gloves with AQL requirements of 1.5. | PASS |
| Powder-Free (ASTM D6124) | Meets applicable acceptance criteria for powder free ≤ 2mg per glove per ASTM D3577-19. | PASS |
| Sterility (ANSI/AAMI/ISO 11137-1:2006) | Meets acceptance criteria requirement of 10-6 SAL per ISO 11137-1: Sterilization for Health Care Products - Radiation - Part 1: Requirements for Development, Validation and Routine Control of A Sterilization Process For Medical Devices. | PASS |
| Chemotherapy Drug Permeation Test (ASTM D6978-05(2019)) | Acceptance Criteria in accordance with ASTM D6978-05(2019): Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs. (Specific breakthrough times for each drug are listed in the "Indications for Use" section). | PASS (with specific breakthrough times. Noted that Carmustine (24.1 min) and Thiotepa (26.0 min) have extremely low permeation times, leading to a warning for these drugs.) |
| ISO in vitro Cytotoxicity (ISO 10993-5) | Acceptance criteria in accordance with ISO 10993-5: Biological Evaluation of Medical Devices, Part 5: Tests for In Vitro Cytotoxicity, 2009. | FAIL (Surfaces at undiluted were found to be cytotoxic (grade 4) to L-929 cells and non-cytotoxic with grade 0 at 1:2, 1:4, 1:8, 1:16, 1:32 and 1;64 dilutions.) |
| ISO Skin Irritation Study (ISO 10993-10:2010) | Passes Primary Skin Irritation test per ISO 10993-10, Biological Evaluation Of Medical Devices, Part 10: Test for Irritation and Skin Sensitization. Under the conditions of the study, not an irritant. | PASS |
| ISO Maximization Sensitization Study (ISO 10993-10:2010) | Passes Dermal Sensitization test per ISO 10993-10, Biological Evaluation of medical devices, Part 10: Test for Irritation and Skin Sensitization. Under the conditions of the study, not a sensitizer. | PASS |
| ISO Acute Systemic Toxicity Study (ISO 10993-11:2017) | Passes Acute Systemic Toxicity Test per ISO 10993-11, Biological Evaluation of medical devices, Part 11: Test for Systemic Toxicity. Under the conditions of the study, there was no mortality or evidence of acute systemic toxicity. | PASS |
| Material Mediated Pyrogenicity Study (USP ) | Passes Material Mediated Pyrogenicity Test per USP . Under the conditions of the study, non-pyrogenic. | PASS |
| Endotoxin Study | Less than 20.0 EU/device. | PASS |
Note regarding Cytotoxicity: Although the in vitro cytotoxicity test showed a "FAIL" at undiluted concentrations, the document states that the extracts were then evaluated by ISO 10993-11 for systemic toxicity, which passed, indicating no systemic response in the animal model. This suggests a different acceptance pathway for cytotoxicity, likely due to further evaluation in an in vivo model.
2. Sample size used for the test set and the data provenance:
- The document does not explicitly state the specific sample sizes for each non-clinical test.
- The data provenance is from non-clinical tests performed by Ansell Healthcare at independent laboratories. There is no information regarding country of origin, but it is implied to be laboratory-based testing rather than human subject data. The studies are by nature prospective as they are conducted for the purpose of demonstrating safety and performance.
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. These are non-clinical tests based on standardized laboratory methods (e.g., ASTM, ISO, USP), not interpretation by human experts. The "ground truth" is defined by the objective measurement criteria of these standards.
4. Adjudication method for the test set:
- This information is not applicable, as the tests are objective measurements according to standardized protocols, 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:
- This information is not applicable. The device is a surgical glove, not an AI-assisted diagnostic or therapeutic device that would involve human readers or AI.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- This information is not applicable. The device is a physical product (surgical glove), not an algorithm or software.
7. The type of ground truth used:
- The ground truth used for these tests is based on established international and national standards and methodologies (e.g., ASTM, ISO, USP) for evaluating the physical, chemical, and biological properties of medical devices like surgical gloves. These standards define the objective criteria and test methods to determine acceptable performance.
8. The sample size for the training set:
- This information is not applicable. This is a physical medical device, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established:
- This information is not applicable, as it's not a machine learning driven device.
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(88 days)
KGO
The polyisoprene powder free, black colour surgical gloves are radiation attenuating and intended to be worn by operating room personal to protect a surgical wound from contamination
The Polyisoprene Powder Free Black Color Radiation Attenuating Surgical Glove is a disposable sterile powder-free medical device made of polyisoprene that is intended to be worn by operating room personnel to protect a surgical wound from contamination. The glove contains radiation-attenuating particles to reduce the exposure from harmful ionizing scattered or secondary radiation on the operator's hand during fluoroscopic procedures. The glove is proposed in two (2) options. The Model 2 are made with exactly the same material and composition and differ only by their thicknesses and therefore their attenuation properties.
The provided text describes the acceptance criteria and results of non-clinical performance testing for a medical device, specifically Polyisoprene Powder Free Black Colour Radiation Attenuating Surgical Gloves. It does not describe a study involving AI or human readers for diagnostic purposes. Therefore, most of the requested fields related to AI performance, human reader studies, and training data are not applicable based on the provided document.
Here's a summary of the available information:
1. A table of acceptance criteria and the reported device performance:
| Test Method | Test Purpose | Acceptance Criteria | Reported Device Performance (Results) |
|---|---|---|---|
| ASTM D5151 | Freedom from holes | AQL 1.5 | PASS (AQL=0.65) |
| ASTM D3577 | Physical Dimensions - Length (Size 6-9) | ≥265mm (Predicate) / ≥285mm (Manufacturer) | PASS (All sizes ≥285mm, range: 298-301mm) |
| ASTM D3577 | Physical Dimensions - Width (various sizes) | Size 6.0: 76 ± 6mm | |
| Size 6.5: 83 ± 6mm | |||
| Size 7: 89 ± 6mm | |||
| Size 7.5: 95 ± 6mm | |||
| Size 8: 102 ± 6mm | |||
| Size 8.5: 108 ± 6mm | |||
| Size 9: 114 ± 6mm | PASS (83-84mm (size 6.5) | ||
| 90-91mm (size 7) | |||
| 96-97mm (size 7.5) | |||
| 106-107mm (size 8) | |||
| 110-113mm (size 8.5) | |||
| 112-115mm (size 9)) | |||
| ASTM D3577 | Physical Dimensions - Thickness | Min. 0.1mm | PASS (Model 1: Finger: 0.27-0.29mm, Palm: 0.24-0.25mm, Cuff: 0.23-0.24mm; Model 2: Finger: 0.33-0.39mm, Palm: 0.33-0.35mm, Cuff: 0.31-0.33mm) |
| ASTM D3577 | Physical Properties - Tensile Strength (Before accelerated aging) | 17 MPa min | PASS (18.7-19.6MPa) |
| ASTM D3577 | Physical Properties - Tensile Strength (After accelerated aging) | 12 MPa min | PASS (18.2-18.5MPa) |
| ASTM D3577 | Physical Properties - Strength at 500% | 7.0 MPa max | PASS (4.1-4.9MPa) |
| ASTM D3577 | Physical Properties - Ultimate Elongation (Before aging) | 650 % min | PASS (700-720%) |
| ASTM D3577 | Physical Properties - Ultimate Elongation (After aging) | 490 % min | PASS (620-645%) |
| ASTM D6124 | Residual powder |
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(127 days)
KGO
The Single-Use Latex Sterile Surgical Gloves are device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
The proposed device, Single-Use Latex Sterile Surgical Gloves is a sterilized and disposable medical glove intended to be worn by operating room personnel to protect a surgical wound from contamination. The proposed device is made of natural rubber latex, per standard ASTM D3577- 09(15), the rubber surgical gloves classification is: Type 1-qloves compounded primarily from nature rubber latex." The qloves are powderfree and available in white in sizes 6, 6.5, 7, 7.5, 8, 8.5 and 9. The proposed device is provided Radiation sterilized to achieve the sterility Assurance Level (SAL) of 10-6. The latex surgical glove shelf life is 3 years.
This document is a 510(k) Pre-market Notification for a medical device, specifically Single-Use Latex Sterile Surgical Gloves (SG100). It focuses on demonstrating substantial equivalence to a predicate device, not necessarily a comprehensive study proving novel effectiveness.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document presents two tables relevant to acceptance criteria and device performance:
Table 1: Comparison of Technological Characteristics (Proposed vs. Predicate) - This table indirectly shows performance against standards and similarities with the predicate.
| Characteristic | Acceptance criteria of the standard (Implied or Explicit) | Proposed device K231446 | Predicate device K212848 | Remarks |
|---|---|---|---|---|
| Product name | N/A (Comparison, not an acceptance criterion) | Single-Use Latex Sterile Surgical Gloves | Sterile Latex Surgical Gloves Powder Free | Similar |
| Indications For Use | N/A (Comparison, not an acceptance criterion) | To protect surgical wound from contamination | To protect surgical wound from contamination | Similar |
| Product Code | KGO | KGO | KGO | Same |
| Regulation Number | 21 CFR 878.4460 | 21 CFR 878.4460 | 21 CFR 878.4460 | Same |
| Powdered or Powder free | Powdered free | Powdered free | Powdered free | Same |
| Classification as per ASTM D3577-2019 | Type I - gloves compounded primarily from natural rubber latex | Type I - gloves compounded primarily from natural rubber latex | Type I - gloves compounded primarily from natural rubber latex | Same |
| Type of use | Over the counter use | Over the counter use | Over the counter use | Same |
| Shelf Life | 3 Years | 3 Years | 3 Years | Same |
| Sterilization | Radiation, SAL- 10-6 | Radiation, SAL- 10-6 | Radiation, SAL- 10-6 | Same |
| Single use | Yes | Yes | Yes | Same |
| Label and Labeling | Meet FDA's Requirement | Meet FDA's Requirement | Meet FDA's Requirement | Same |
| Protein Content | N/A (Comparison, predicate has a lower value, but both meet ) |
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(183 days)
KGO
A powder-free sterile surgeon's glove is a disposable device made of synthetic rubber intended to be worn on the hands of healthcare personnel as a barrier for protection against cross-contamination between the healthcare personnel and patient. These gloves were tested for use with Chemotherapy Drugs as per ASTM D6978 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs: Chemotherapy Drug Permeation The following chemicals have been tested with these gloves. (Table of chemotherapy drugs and breakthrough times) Fentanyl Citrate Injection 100mcg/2mL No breakthrough up to 240 minutes
This is a disposable polyisoprene surqical glove that is tested for use with chemotherapy drugs and fentanyl. The device is composed of two layers which are not attached in the fingers or palm/back of hand region, but are attached in the cuff area. The outer layer of the glove is white and the inner layer is green. The glove is supplied in the following sizes: 5½, 6, 6½, 7, 7½, 8, 81/2 and 9, and is provided sterile. No shelf life is claimed.
Here's a breakdown of the acceptance criteria and the study information based on the provided document:
This document is a 510(k) premarket notification for a medical device (surgical gloves), which primarily relies on non-clinical testing to demonstrate substantial equivalence to a predicate device. Therefore, many of the questions related to clinical studies, expert-based ground truth, and human-in-the-loop performance are not applicable (N/A) in this context.
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic/Test Method | Standard/Purpose of Testing | Acceptance Criteria | Reported Device Performance (K230578) |
|---|---|---|---|
| Physical Properties | |||
| Before Aging Outer Layer: Tensile Strength | ASTM D412 (Standard Test Method for Vulcanized Rubber and Thermoplastic Elastomers) | Min. 17MPa | Pass (Meets) |
| Before Aging Outer Layer: Ultimate Elongation | ASTM D412 | Min. 650% | Pass (Meets) |
| Before Aging Outer Layer: Stress at 500% Elongation | ASTM D412 | Max. 7.0MPa | Pass (Meets) |
| After Aging Outer Layer: Tensile Strength | ASTM D412 | Min. 12MPa | Pass (Meets) |
| After Aging Outer Layer: Ultimate Elongation | ASTM D412 | Min. 490% | Pass (Meets) |
| Before Aging Inner Layer: Tensile Strength | ASTM D412 | Min. 17MPa | Pass (Meets) |
| Before Aging Inner Layer: Ultimate Elongation | ASTM D412 | Min. 650% | Pass (Meets) |
| Before Aging Inner Layer: Stress at 500% Elongation | ASTM D412 | Max. 7.0MPa | Pass (Meets) |
| After Aging Inner Layer: Tensile Strength | ASTM D412 | Min. 12MPa | Pass (Meets) |
| After Aging Inner Layer: Ultimate Elongation | ASTM D412 | Min. 490% | Pass (Meets) |
| Before Aging Cuff Region: Tensile Strength | ASTM D412 | Min. 17MPa | Pass (Meets) |
| Before Aging Cuff Region: Ultimate Elongation | ASTM D412 | Min. 650% | Pass (Meets) |
| Before Aging Cuff Region: Stress at 500% Elongation | ASTM D412 | Max. 7.0MPa | Pass (Meets) |
| After Aging Cuff Region: Tensile Strength | ASTM D412 | Min. 12MPa | Pass (Meets) |
| After Aging Cuff Region: Ultimate Elongation | ASTM D412 | Min. 490% | Pass (Meets) |
| Dimension (Length, Width, Thickness) | ASTM D3767 (Standard Practice for Rubber - Measurement of Dimensions) | Each size satisfies ASTM requirement (specific ranges listed for each size, e.g., 5½: Min. 245mm length, 70 ± 6 mm width) | Pass (Each size satisfies ASTM requirement) |
| Watertight | ASTM D5151 (Standard Test Method for Detection of Holes in Medical Gloves) | Freedom from holes AQL 1.5 | Pass |
| Residual Powder | ASTM D6124 (Standard Test Method for Residual Powder and non-powder solids on Medical Gloves) | Have a powder residue below 2.0 mg per glove | Pass |
| Biocompatibility: Primary Skin Irritation | ISO 10993-10 (E) | Under the conditions of the study, not an irritant | Pass (Not an irritant) |
| Biocompatibility: Dermal Sensitization | ISO 10993-10 (E) | Under the conditions of the study, not a sensitizer | Pass (Not a sensitizer) |
| Biocompatibility: Acute Systemic Toxicity | ISO 10993-11 (E) | Under the conditions of the study, no acute systemic toxicity | Pass (No acute systemic toxicity) |
| Biocompatibility: Material Mediated Pyrogenicity | ISO 10993-11 (E) | Under the conditions of the study, non-pyrogenic | Pass (Non-pyrogenic) |
| Biocompatibility: Bacterial Endotoxins | LAL Gel Clot, ANSI/AAMI CT73 | ≤20 EU/device | Pass |
| Chemotherapy Drug Permeation (ASTM D6978-05) | Minimum Breakthrough Detection Time for specific drugs (see Chemo Drug Permeation table) | Varies by drug (e.g., Carmustine: 67.6 min, Cisplatin: > 240 min, Thiotepa: 77.7 min) | |
| Fentanyl Resistant (ASTM D6978-05) | No breakthrough up to 240 minutes for Fentanyl Citrate Injection (100mcg/2mL) | No breakthrough up to 240 minutes |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes used for each non-clinical test (e.g., how many gloves were tested for tensile strength or dimensional analysis). It refers to standard test methods (e.g., ASTM D412, ASTM D3767, ASTM D5151, ASTM D6124, ISO 10993-10, ISO 10993-11, ASTM D6978-05), which inherently define the required sample sizes for conducting those tests to achieve statistically valid results according to their respective standards. The data provenance is Malaysia, as the submitter (WRP Asia Pacific Sdn. Bhd.) is located in Malaysia. The testing is retrospective, conducted specifically for this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
N/A. This device's performance is established through objective, standardized physical and chemical testing, not expert interpretation of cases or images.
4. Adjudication method for the test set
N/A. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or studies involving human readers, where there's subjectivity in interpretation. This is not relevant for the objective physical and chemical tests performed on the surgical gloves.
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
N/A. This is not an AI-assisted device. The device itself is a surgical glove.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
N/A. This is not an algorithm or AI-based device.
7. The type of ground truth used
The "ground truth" for the performance of the surgical gloves is established by objective measurements against established industry standards and regulatory requirements. For example:
- Physical Properties: Measured tensile strength, elongation, and stress values are compared against minimum/maximum thresholds defined by ASTM D3577 and D412.
- Dimensions: Measured lengths, widths, and thicknesses are compared against specified ASTM D3577 requirements for each glove size.
- Watertightness: The number of detected holes is compared against the Acceptable Quality Limit (AQL) of 1.5 as per ASTM D5151 and D3577.
- Residual Powder: The measured powder residue is compared against the limit of ≤2.0 mg/glove as per ASTM D6124 and D3577.
- Biocompatibility: Biological responses (irritation, sensitization, systemic toxicity, pyrogenicity) are evaluated against the criteria for "Pass" as defined by ISO 10993-10 and ISO 10993-11.
- Chemotherapy Drug Permeation and Fentanyl Resistance: The breakthrough detection times are measured according to ASTM D6978 and compared against established timeframes.
8. The sample size for the training set
N/A. This is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established
N/A. Not applicable as there is no training set for this device.
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(225 days)
KGO
These surgical gloves are intended to be worn by operating room personnel to protect a surgical wound from contamination. These gloves were tested for use with chemotherapy drugs, have low dermatitis potential, and are nonpyrogenic. These gloves were tested for use with Chemotherapy Drugs as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
Polyisoprene Surgical Gloves Tested for Use with Chemotherapy Drugs and Low Dermatitis Potential are sterile and disposable devices. Gloves are made of synthetic polyisoprene rubber, are white in color, and are available in sizes 5.5, 6.0, 6.5, 7.0, 7.5, 8.0, 8.5, and 9.0. A polyurethane polymer coating is applied to the inner surface of the glove to make donning easy.
This document is a 510(k) premarket notification for a medical device: "Polyisoprene Surgical Gloves Tested for Use with Chemotherapy Drugs and Low Dermatitis Potential" (K230079). It compares the new device to a predicate device (K190018) and provides evidence of performance through various tests.
Here's an analysis of the acceptance criteria and supporting studies based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document presents a comparison of the subject device (K230079) against a predicate device (K190018) and also summarizes non-clinical testing. Below is a compilation of the acceptance criteria (standards/guidance/test criteria) and the reported device performance.
| Test/Characteristic | Acceptance Criteria (Standard/Guidance/Criteria) | Reported Device Performance (K230079) |
|---|---|---|
| Chemotherapy Permeation | ASTM D6978-05 (2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs | All drugs with BDT >240 minutes met criteria. |
| Carmustine (BCNU) (3.3 mg/ml): 12.6 minutes | ||
| Thiotepa (10.0 mg/ml): 26.6 minutes | ||
| (Note: For marketing, the device labels a warning against using with Carmustine and Thiotepa due to "extremely low permeation times".) | ||
| Dimensions (Length) | ASTM D3577 requirements: Minimum 265mm | Pass |
| Dimensions (Palm Width) | ASTM D3577 requirements (specific to each size 5.5-9.0, e.g., 5.5: 70±6mm, 9.0: 114±6mm) | Pass for all sizes |
| Dimensions (Thickness - Finger) | ASTM D3577 requirements: Minimum 0.10mm | Pass |
| Dimensions (Thickness - Palm) | ASTM D3577 requirements: Minimum 0.10mm | Pass |
| Dimensions (Thickness - Cuff) | ASTM D3577 requirements: Minimum 0.10mm | Pass |
| Physical Properties | ASTM D3577-19 requirements for tensile strength, ultimate elongation, and stress at 500% elongation before and after accelerated aging for synthetic surgical gloves | Pass |
| Freedom from holes | ASTM D3577-19 and ASTM D5151-06 requirements; AQL 1.5 | Pass |
| Powder-Free | ASTM D3577-19, ASTM D6124-06 requirements: ≤ 2 mg per glove | Pass |
| Sterility | ANSI/AAMI/ISO 11137-1:2018 requirement of 10^-6 SAL | Pass |
| ISO In Vitro Cytotoxicity | ISO 10993-5:2009: Non-cytotoxic (as the general acceptance criteria) | Under the conditions of the study, the device was found to be cytotoxic. However, "the device extracts did not elicit acute systemic response in the animal model" in the follow-up Acute Systemic Toxicity test (ISO 10993-11). This is a notable finding, indicating the device failed the initial cytotoxicity but was deemed safe due to subsequent testing. |
| ISO Skin Irritation Study | ISO 10993-10:2010: Not an irritant | Pass |
| ISO Maximization Sensitization Study | ISO 10993-10:2010: Not a sensitizer | Pass |
| ISO Acute Systemic Toxicity Study | ISO 10993-11:2006: No mortality or evidence of acute systemic toxicity | Pass (addressed after initial cytotoxicity finding) |
| Human Skin Sensitization | Modified Draize-95 Test (per FDA guidance): Not a sensitizer (demonstrates low dermatitis potential) | Pass: "The results showed low dermatitis potential for the human subject tested." |
| Endotoxin Study | Less than 20.0 EU/device | Pass: "test results indicate low endotoxin level" |
| Material Mediated Pyrogenicity Study | ISO 10993-11:2017: Meets the material mediated pyrogenicity requirement | Pass |
2. Sample Size Used for the Test Set and Data Provenance:
- Chemotherapy Drug Permeation (ASTM D6978-05): The document specifies the standard used but does not provide the exact sample size for the test sets (number of gloves or replicates per drug). The data is generated from laboratory testing ("under the conditions of the study"). Data provenance is not explicitly stated but implies laboratory testing for regulatory submission.
- Dimensions, Physical Properties, Freedom from Holes, Powder-Free, Sterility: These tests refer to ASTM and ISO standards (e.g., ASTM D3577, ASTM D5151, ASTM D6124, ISO 11137-1). These standards typically define the sampling plans (e.g., AQL 1.5 for freedom from holes), but the specific number of units tested for this submission is not directly stated. Data provenance implies manufacturer's testing for regulatory submission.
- Biocompatibility (ISO 10993 series): These are biological evaluations. The document refers to "the conditions of the study" and "animal model" for acute systemic toxicity but does not provide specific sample sizes (e.g., number of animals used). Data provenance implies laboratory testing for regulatory submission.
- Human Skin Sensitization (Modified Draize-95 Test): This test was performed on "human subject tested." The sample size (number of human subjects) is not explicitly given, it ambiguously states "the human subject tested." Data provenance is from a clinical test as per FDA guidance.
- Endotoxin Study & Material Mediated Pyrogenicity Study: The document refers to "the conditions of the study" but does not provide sample sizes. Data provenance implies laboratory testing for regulatory submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
This submission is for a physical device (surgical gloves) and its material properties, not an AI/algorithm-driven device requiring expert image interpretation or similar ground truth establishment. Therefore, the concept of "experts" establishing a ground truth in that context is not applicable here. The "ground truth" for the performance tests (e.g., breakthrough time, tensile strength) is established by the validated methodologies of the referenced ASTM and ISO standards.
4. Adjudication Method for the Test Set:
Not applicable in the context of material and physical property testing of a device like surgical gloves. Test results are objective measurements based on defined standard protocols.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No, an MRMC comparative effectiveness study was not done. This is not an AI device or a diagnostic imaging device where human reader performance is evaluated.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done:
Not applicable as this is not an AI/algorithm device. The performance tests evaluate the physical gloves without any "human-in-the-loop" interaction in the testing methodology itself beyond conducting the tests.
7. The Type of Ground Truth Used:
- Objective Measurement Standards: For most physical and chemical properties (dimensions, strength, freedom from holes, powder, sterility, chemotherapy permeation, endotoxin, pyrogenicity), the "ground truth" is defined by the objective measurement criteria and methodologies specified in the referenced ASTM and ISO standards. The results are quantitative measurements against these predefined thresholds.
- Biological Response in Models: For biocompatibility tests (cytotoxicity, skin irritation, sensitization, acute systemic toxicity), the "ground truth" is established by observing biological responses in in vitro or in vivo (animal) models as per ISO 10993 standards and the Modified Draize-95 Test for human skin sensitization.
8. The Sample Size for the Training Set:
Not applicable. This is not an AI/machine learning device that requires a training set. The device is a manufactured physical product.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for this type of device.
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(324 days)
KGO
A powder-free surgeon's glove is a device made of synthetic elastomer that is intended to be worn by operating room personnel to protect a surgical wound from contamination. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs and ASTM D6355-07, Standard Test Method for Human Repeat Insult Patch Testing of Medical Gloves.
A powder-free surgeon's glove is a device made of synthetic elastomer that is intended to be worn by operating room personnel to protect a surgical wound from contamination.
This document is an FDA 510(k) clearance letter for two types of surgical gloves (Flexylon Surgical Powder Free Gloves, Green and White variants). The core of this clearance is demonstrating substantial equivalence to a predicate device, which primarily relies on performance testing against established ASTM standards for chemotherapy drug permeation and dermatitis potential, rather than the kind of AI/machine learning study typically associated with your questions.
Therefore, many of the requested categories (e.g., "Sample sized used for the test set and the data provenance," "Number of experts used to establish the ground truth," "Adjudication method," "MRMC comparative effectiveness study," "Training set sample size," "Ground truth for the training set") are not applicable to this type of device clearance and the information provided in the document.
However, I can extract the relevant acceptance criteria and reported device performance from the document.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for chemotherapy drug permeation are implicitly defined by the results obtained when tested against the ASTM D6978 standard. For a glove to be considered "tested for use with chemotherapy drugs," the breakthrough detection time for each drug needs to be reported. There isn't a single universal "acceptance criterion" beyond demonstrating the performance as per the standard. For many drugs, a breakthrough time of ">240 minutes" indicates good resistance. For certain drugs, the breakthrough time is low, and the FDA has added warnings.
| No. | Chemotherapy Drugs (Green Gloves) | Concentration | Breakthrough Detection Time in Minutes (Reported) | Acceptance Criteria (Implied) | Notes/Warnings |
|---|---|---|---|---|---|
| 1. | Carmustine | 3.3 mg/ml | 7.7 | N/A (performance reported) | Extremely low, do not use. |
| 2. | Cisplatin | 1.0 mg/ml | >240 | N/A (performance reported) | Good resistance. |
| 3. | Cyclophosphamide | 20.0 mg/ml | >240 | N/A (performance reported) | Good resistance. |
| 4. | Dacarbazine | 10.0 mg/ml | >240 | N/A (performance reported) | Good resistance. |
| 5. | Doxorubicin HCl | 2.0 mg/ml | >240 | N/A (performance reported) | Good resistance. |
| 6. | Etoposide | 20.0 mg/ml | >240 | N/A (performance reported) | Good resistance. |
| 7. | Fluorouracil | 50.0 mg/ml | >240 | N/A (performance reported) | Good resistance. |
| 8. | Ifosfamide | 50.0 mg/ml | >240 | N/A (performance reported) | Good resistance. |
| 9. | Methotrexate | 25.0 mg/ml | >240 | N/A (performance reported) | Good resistance. |
| 10. | Mitomycin C | 0.5 mg/ml | >240 | N/A (performance reported) | Good resistance. |
| 11. | Paclitaxel (Taxol) | 6.0 mg/ml | >240 | N/A (performance reported) | Good resistance. |
| 12. | Thiotepa | 10.0 mg/ml | 11.4 | N/A (performance reported) | Extremely low, do not use. |
| 13. | Vincristine Sulfate | 1.0 mg/ml | >240 | N/A (performance reported) | Good resistance. |
| No. | Chemotherapy Drugs (White Gloves) | Concentration | Breakthrough Detection Time in Minutes (Reported) | Acceptance Criteria (Implied) | Notes/Warnings |
|---|---|---|---|---|---|
| 1. | Carmustine | 3.3 mg/ml | 11.9 | N/A (performance reported) | Extremely low, do not use. |
| 2. | Cisplatin | 1.0 mg/ml | >240 | N/A (performance reported) | Good resistance. |
| 3. | Cyclophosphamide | 20.0 mg/ml | >240 | N/A (performance reported) | Good resistance. |
| 4. | Dacarbazine | 10.0 mg/ml | >240 | N/A (performance reported) | Good resistance. |
| ... | (Additional 28 drugs for White Gloves) | ... | >240 for most, 12.3 for Thiotepa | N/A (performance reported) | Good resistance for most. Thiotepa is extremely low, do not use. |
| 12. | Thiotepa | 10.0 mg/ml | 12.3 | N/A (performance reported) | Extremely low, do not use. |
For the "Low Dermatitis Potential Claim," the acceptance criterion would be that the glove meets the requirements of ASTM D6355-07, which is "Standard Test Method for Human Repeat Insult Patch Testing of Medical Gloves." The document states the gloves were tested according to this standard, implying they met its criteria for a low dermatitis potential claim.
Study Proving Device Meets Acceptance Criteria:
The studies proving the device meets the acceptance criteria are referenced as:
- ASTM D6978 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs
- ASTM D6355-07, Standard Test Method for Human Repeat Insult Patch Testing of Medical Gloves
These are standardized testing methods, not complex AI or clinical studies. The results of these tests are presented in the tables above.
Non-Applicable / Not Provided Information:
For the remaining points, the information is either not applicable to this type of device submission or not provided in the FDA clearance letter:
- Sample sized used for the test set and the data provenance: Not explicitly stated in the document. ASTM standards typically specify sample sizes for testing. The data provenance would be laboratory testing results.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The "ground truth" for permeation is determined by scientific measurement according to the ASTM D6978 standard, and for dermatitis potential by the ASTM D6355-07 standard. This does not involve expert consensus in the way an AI model might.
- Adjudication method for the test set: Not applicable. Standardized laboratory testing methods are employed.
- If a multi reader multi case (MRMC) comparative effectiveness study was done: No, this is not relevant for glove testing. This is typically for diagnostic imaging devices.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No, this is not an AI/algorithm-based device.
- The type of ground truth used: For chemotherapy permeation, the ground truth is the directly measured breakthrough time of the drug through the glove material. For dermatitis potential, the ground truth is determined by the results of human repeat insult patch testing as per ASTM D6355-07.
- The sample size for the training set: Not applicable, as this is not an AI/machine learning device.
- How the ground truth for the training set was established: Not applicable, as this is not an AI/machine learning device.
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