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510(k) Data Aggregation
(82 days)
The glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. Gloves have been tested for use with chemotherapy drugs and Fentanyl Citrate using ASTM D6978-05(2019)
Aloe Vera Nitrile Examination Gloves (Green) Tested for Use with Chemotherapy Drugs and Fentanyl Citrate are Class I Patient Examination Gloves and Specialty Chemotherapy Gloves. They are ambidextrous and come in different sizes - Extra Small, Small, Medium, Large, Extra Large and XXL. Gloves meet the specification of ASTM D6319-19 and have been tested for resistance to permeation by chemotherapy drugs and Fentanyl Citrate as per ASTM D6978-05(2019). The gloves are single use, disposable, and provided non-sterile.
The provided document describes the acceptance criteria and study results for the "Aloe Vera Nitrile Examination Gloves (Green) Tested for Use with Chemotherapy Drugs and Fentanyl Citrate" (K240080).
Here's the breakdown:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the gloves are based on various physical characteristics, chemical permeation resistance (as per ASTM D6978-05(2019)), and biocompatibility tests (as per ISO 10993 standards). The reported device performance is compared to these criteria and, in some cases, to a predicate device (K200671).
Physical and Design Characteristics (Meeting ASTM D6319-19):
| Characteristic | Acceptance Criteria (Subject Device K240080) | Reported Device Performance (Subject Device K240080) |
|---|---|---|
| Length (Minimum) | XS: ≥ 220 mm, S: ≥ 220 mm, M: ≥ 230 mm, L: ≥ 230 mm, XL: ≥ 230 mm, XXL: ≥ 230 mm | Meets ASTM D6319-19 requirements |
| Palm Width (mm) | XS: 70±10, S: 80±10, M: 95±10, L: 110±10, XL: 120±10, XXL: 130±10 | Meets ASTM D6319-19 requirements |
| Thickness (mm) (Minimum) | Finger: 0.05, Palm: 0.05 | Meets ASTM D6319-19 requirements |
| Tensile Strength, Before Aging, min | 14 MPa | 14 MPa |
| Ultimate Elongation, Before Aging, min | 500% | 500% |
| Tensile Strength, After Accelerated Aging, min | 14 MPa | 14 MPa |
| Ultimate Elongation, After Accelerated Aging, min | 400% | 400% |
| Freedom from holes | G-I, AQL 2.5 | G-I, AQL 2.5 |
| Powder residual | ≤ 2 mg per glove | ≤ 2 mg per glove |
Chemotherapy Permeation Resistance (ASTM D6978-05(2019)):
| Chemotherapy Drug | Acceptance Criteria (Minimum Permeation Time from Predicate or Acceptable Performance) | Reported Device Performance (Minimum BDT in Minutes for K240080) |
|---|---|---|
| Carmustine 3.3 mg/ml (3,300 ppm) | Similar to predicate (23.4 minutes) | 21.2 |
| Cisplatin, 1mg/ml (1000 ppm) | N/A (predicate did not test this) | >240 |
| Cyclophosphamide 20mg/ml (20,000 ppm) | >240 | >240 |
| Dacarbazine, 10 mg/ml (10,000 ppm) | N/A (predicate did not test this) | >240 |
| Doxorubicin HCL, 2 mg/ml (2,000 ppm) | >240 | >240 |
| Etoposide, 20 mg/ml (20,000 ppm) | >240 | >240 |
| Fluorouracil (5 Flu), 50mg/ml (50,000ppm) | >240 | >240 |
| Methotrexate, 25mg/ml (25,000ppm) | >240 | >240 |
| Mitomycin C, 0.5mg/ml (500 ppm) | N/A (predicate did not test this) | >240 |
| Paclitaxel, 6mg/ml (6,000ppm) | >240 | >240 |
| Thiotepa, 10mg/ml (10,000ppm) | Similar to predicate (64.9 minutes) | 24.9 |
| Vincristine sulfate, 1mg/ml (1000 ppm) | >240 | >240 |
Fentanyl Citrate Permeation Resistance (ASTM D6978-05(2019)):
| Fentanyl Citrate | Acceptance Criteria (Minimum Permeation Time) | Reported Device Performance (Minimum BDT in Minutes for K240080) |
|---|---|---|
| Fentanyl Citrate Injection, 100mcg/2mg | >240 | >240 |
Biocompatibility (ISO 10993 Standards):
| Test | Acceptance Criteria | Reported Device Performance (K240080) |
|---|---|---|
| In vitro Cytotoxicity ISO 10993-5 | Absence of cytotoxicity or similar to predicate (cytotoxic at certain dilutions, non-cytotoxic at others) | Showed potential toxicity to L929 cells (similar to predicate which was cytotoxic at higher concentrations). |
| Acute Systemic Toxicity Test ISO 10993-11 | No evidence of acute systemic toxicity | No evidence of acute systemic toxicity. |
| Dermal Sensitization ISO 10993-10 | No evidence of causing skin sensitization | No evidence of causing skin sensitization. |
| Primary Skin Irritation ISO 10993-23 | Negligible response/not an irritant | Response categorized as negligible under the test condition. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not explicitly state the specific sample sizes used for each test. However, it indicates that tests were conducted according to recognized international standards such as ASTM D6319-19 (Standard Specification for Nitrile Examination Gloves for Medical Application), ASTM D6978-05(2019) (Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs), and ISO 10993 series for biocompatibility. These standards typically specify the number of samples required for testing.
The data provenance is not explicitly stated as 'country of origin' in that format, but the applicant is "Syntex Healthcare Products Co., Ltd" from "Xinji, Hebei, China," indicating the testing likely occurred under their purview or by contracted labs. The studies appear to be prospective testing conducted specifically for this premarket notification.
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 information is not applicable as the document describes performance testing of a physical medical device (gloves) against established engineering and biocompatibility standards. It does not involve interpretation of medical images or patient data by human experts for ground truth establishment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable for the same reason as point 3. Testing involves objective measurements against predefined 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 as the device is a medical glove, not an AI-powered diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable as the 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 this device's performance is based on established international and national standards for medical gloves:
- ASTM D6319-19: for physical dimensions and integrity (e.g., freedom from holes, tensile strength).
- ASTM D6978-05(2019): for resistance to permeation by chemotherapy drugs and Fentanyl Citrate, where "breakthrough detection time" is the key metric.
- ISO 10993 series (ISO 10993-5, -10, -11, -23): for biocompatibility assessments like cytotoxicity, sensitization, irritation, and systemic toxicity.
8. The sample size for the training set
This information is not applicable as the device is a physical product and does not involve machine learning or AI models with training sets.
9. How the ground truth for the training set was established
This information is not applicable as the device is a physical product and does not involve machine learning or AI models.
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(95 days)
The glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. Gloves have been tested for use with chemotherapy drugs and Fentanyl Citrate using ASTM D6978-05(2019)
Biodegradable Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) are Class I Patient Examination Gloves and Specialty Chemotherapy Gloves. They are ambidextrous and come in different sizes - Extra Small, Medium, Large, Extra Large and XXL. Gloves meet the specification of ASTM D6319-19 and have been tested for resistance to permeation by chemotherapy drugs and Fentanyl Citrate as per ASTM D6978-05(2019). The gloves are single use, disposable, and provided non-sterile. The glove has biodegradation property tested per ASTM D5511. Biodegradability is not a medical claim and therefore was not reviewed by the FDA.
This document is a 510(k) summary for the Syntex Healthcare Products Co., Ltd.'s "Biodegradable Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue)". It describes the device, its intended use, and the non-clinical tests performed to demonstrate its substantial equivalence to predicate devices.
Here's the breakdown of the acceptance criteria and the study proving the device meets them:
1. A table of acceptance criteria and the reported device performance:
The device's performance is primarily evaluated against recognized standards for medical examination gloves and specific tests for chemical permeation.
| Acceptance Criteria (Standard & Parameter) | Reported Device Performance |
|---|---|
| Physical Dimensions (ASTM D6319-19) | |
| Length (XS, S) | Minimum 220mm (Pass) |
| Length (M-XXL) | Minimum 230mm (Pass) |
| Palm Width (XS) | 70±10mm (Pass) |
| Palm Width (S) | 80±10mm (Pass) |
| Palm Width (M) | 95±10mm (Pass) |
| Palm Width (L) | 110±10mm (Pass) |
| Palm Width (XL) | 120±10mm (Pass) |
| Palm Width (XXL) | 130±10mm (Pass) |
| Thickness (Finger) | Minimum 0.05mm (Pass) |
| Thickness (Palm) | Minimum 0.05mm (Pass) |
| Physical Properties (ASTM D6319-19, ASTM D412-16(2021)) | |
| Tensile Strength (Before Aging) | 14MPa, min (Pass) |
| Ultimate Elongation (Before Aging) | 500%, min (Pass) |
| Tensile Strength (After Accelerated Aging) | 14MPa, min (Pass) |
| Ultimate Elongation (After Accelerated Aging) | 400%, min (Pass) |
| Water Leak Test (ASTM D6319-19, ASTM D5151-19) | |
| AQL | 2.5 (Pass) |
| Powder Residue (ASTM D6319-19, ASTM D6124-06 (2017)) | |
| Max Powder/glove | ≤ 2 mg/glove (Pass) |
| Permeation by Chemotherapy Drugs (ASTM D6978-05 (2019)) | |
| Azacytidine (25 mg/ml) | >240 minutes (Pass) |
| Bleomycin Sulfate (15mg/ml) | >240 minutes (Pass) |
| Busulfan (6mg/ml) | >240 minutes (Pass) |
| Carboplatin (10mg/ml) | >240 minutes (Pass) |
| Carmustine (3.3 mg/ml) | 12.9 minutes |
| Chloroquine (50mg/ml) | >240 minutes (Pass) |
| Cisplatin (1mg/ml) | >240 minutes (Pass) |
| Cyclophosphamide (20mg/ml) | >240 minutes (Pass) |
| Cyclosporin A (100 mg/ml) | >240 minutes (Pass) |
| Cytarabine HCL (100 mg/ml) | >240 minutes (Pass) |
| Dacarbazine (10 mg/ml) | >240 minutes (Pass) |
| Daunorubicin HCL (5 mg/ml) | >240 minutes (Pass) |
| Docetaxel (10 mg/ml) | >240 minutes (Pass) |
| Doxorubicin HCL (2 mg/ml) | >240 minutes (Pass) |
| Etoposide (20 mg/ml) | >240 minutes (Pass) |
| Epirubicin HCL (2 mg/ml) | >240 minutes (Pass) |
| Fludarabine (25 mg/ml) | >240 minutes (Pass) |
| Fluorouracil (50mg/ml) | >240 minutes (Pass) |
| Gemcitabine (38mg/ml) | >240 minutes (Pass) |
| Idarubicin HCL (1mg/ml) | >240 minutes (Pass) |
| Ifosfamide (50mg/ml) | >240 minutes (Pass) |
| Irinotecan (20mg/ml) | >240 minutes (Pass) |
| Mechlorethamine HCI (1mg/ml) | >240 minutes (Pass) |
| Melphalan (5mg/ml) | >240 minutes (Pass) |
| Methotrexate (25mg/ml) | >240 minutes (Pass) |
| Mitomycin C (0.5mg/ml) | >240 minutes (Pass) |
| Mitoxantrone HCL (2mg/ml) | >240 minutes (Pass) |
| Oxaliplatin (5mg/ml) | >240 minutes (Pass) |
| Paclitaxel (6mg/ml) | >240 minutes (Pass) |
| Paraplatin (10mg/ml) | >240 minutes (Pass) |
| Retrovir (10mg/ml) | >240 minutes (Pass) |
| Rituximab (10mg/ml) | >240 minutes (Pass) |
| Thio Tepa (10mg/ml) | 35.6 minutes |
| Topotecan (1mg/ml) | >240 minutes (Pass) |
| Trisenox (1mg/ml) | >240 minutes (Pass) |
| Velcade (Bortezomib) (1mg/ml) | >240 minutes (Pass) |
| Vincristine Sulfate (1mg/ml) | >240 minutes (Pass) |
| Vinorelbine (10 mg/ml) | >240 minutes (Pass) |
| Fentanyl Citrate Injection (100 mcg/2ml) | >240 minutes (Pass) |
| Biocompatibility | |
| Irritation & Skin Sensitization (ISO 10993-10 & -23) | Non-sensitization and Non-irritation (Pass) |
| Cytotoxicity (ISO 10993-5) | Showed potential toxicity to L929 cells |
| Acute Systemic Toxicity (ISO 10993-11) | No evidence of acute systemic toxicity (Pass) |
| Bioburden Study (ISO 11737-1) | No increase in bioburden levels (Pass) |
Note on Chemotherapy Permeation: For Carmustine and Thio Tepa, the reported breakthrough detection times (12.9 minutes and 35.6 minutes respectively) are explicitly noted as "extremely low permeation times" and a warning is issued: "Do not use with Carmustine and Thio Tepa." This indicates that for these specific drugs, the device does not meet an implicit "long duration" acceptance criterion and thus, limitations are clearly stated for safe use.
The study that proves the device meets (or defines limitations for) these criteria is a Summary of Non-Clinical Performance Data (Section 7 and 10 of the provided document).
2. Sample size used for the test set and the data provenance:
The document does not explicitly state the sample sizes used for each specific non-clinical test (e.g., number of gloves for physical dimensions, individual tests for chemotherapy permeation, or biological evaluations). However, the tests are performed according to recognized international standards (ASTM and ISO), which typically specify appropriate sample sizes for testing to ensure statistical validity.
The data provenance is from Syntex Healthcare Products Co., Ltd., located at No. 1, Fanjiazhuang Industrial Zone, Xinji City, Hebei Province, 052360, China. These are retrospective tests conducted by the manufacturer as part of the premarket notification (510(k)) submission process.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the document. For non-clinical performance data like material testing and chemical permeation, "experts" in the sense of clinical decision-makers (e.g., radiologists) are not typically involved in establishing ground truth. The ground truth is objective, defined by the parameters of the test methods (e.g., measuring glove dimensions, detecting chemical breakthrough, evaluating cellular response). The tests are performed by personnel trained in the specific methodologies, likely in a laboratory setting.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
An adjudication method (like 2+1, 3+1) is relevant for studies involving human interpretation or subjective assessments, often when establishing a ground truth from multiple reviewers. Since these are non-clinical laboratory tests with objectively measurable outcomes (e.g., min/mm measurements, detection of chemical permeation, biological response), an adjudication method is not applicable and therefore, none was used. The "ground truth" is determined by the direct results of the standardized 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:
No MRMC comparative effectiveness study was done. This type of study is completely irrelevant for a medical device such as examination gloves, which do not involve human readers or AI assistance in their function or evaluation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
No standalone algorithm-only performance assessment was done. This device is an examination glove, not an AI or software-based medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The ground truth for the non-clinical tests is based on objective measurements and observations according to established ASTM and ISO standards and methodologies.
- Physical properties and dimensions: Direct physical measurements.
- Chemical permeation: Detection of the breakthrough of specific chemicals through the glove material using analytical methods defined in ASTM D6978-05 (2019).
- Biocompatibility: In vitro (cytotoxicity) and in vivo (irritation, sensitization, systemic toxicity) tests with defined endpoints and criteria.
- Bioburden: Microbiological testing to quantify microorganism levels.
8. The sample size for the training set:
Not applicable. This device is not an AI/machine learning device, so there is no "training set." The data presented is from non-clinical performance testing of the final product.
9. How the ground truth for the training set was established:
Not applicable. As there is no training set for an AI/machine learning model, the concept of establishing ground truth for a training set does not apply here.
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(115 days)
A patient examination glove is disposable non-sterile device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Polymer Patient Examination Gloves, 80 LZA, and meets all requirements of ASTM standard D 6319-00a (2005)e1.
The provided documents describe the performance of "Syntex Healthcare Products Co., Ltd. Powder Free Nitrile Examination Glove, Pink". This is a medical device classified as a Class I, 21 CFR 880.6250, Polymer Patient Examination Glove, 80 LZA.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
| Characteristics | Applicable FDA-Recognized Standards | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Dimensions | ASTM D 6319-00a (2005)e1 | Conforms to standard | Meets |
| Physical Properties | ASTM D 6319-00a (2005)e1 | Conforms to standard | Meets |
| Freedom from holes | ASTM D 6319-00a (2005)e1 | Conforms to standard | Meets |
| Residual Powder Test | ASTM D 6319-00a (2005)e1, ASTM D6124-06 | Conforms to standard | Meets |
| Primary Skin Irritation and Sensitization | ISO 10993 Part 10, 16CFR 1500.41, 16CFR 1500.3 | Conforms to standards | Meets |
2. Sample size used for the test set and the data provenance
The document does not specify exact sample sizes for each test. However, the tests are non-clinical (laboratory/material characteristic tests) and typically involve statistical sampling based on the specific ASTM or ISO standard requirements for batch testing. The data provenance is implied to be from the manufacturer's testing in support of their 510(k) submission, likely performed in China (country of origin of the manufacturer) and provided to the FDA. The tests are retrospective, meaning they were conducted on already manufactured devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable as the evaluation of exam gloves against ASTM and ISO standards involves objective laboratory measurements and tests, not subjective interpretation by human experts to establish ground truth. The "ground truth" is the established technical specification defined by the standards themselves.
4. Adjudication method for the test set
This information is not applicable. Adjudication methods like 2+1 or 3+1 refer to a process of resolving discrepancies among multiple human readers for subjective assessments (e.g., medical image interpretation). For the physical and chemical tests conducted on examination gloves, the results are quantitative or qualitative assessments against defined criteria, not requiring 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
An MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic devices where human readers (e.g., radiologists) interpret cases with and without AI assistance. This device is a disposable examination glove, not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
A standalone performance study was not done. This question is also relevant for AI algorithms. The performance of the examination glove is measured by its physical and chemical properties and biocompatibility, not by an algorithm.
7. The type of ground truth used
The "ground truth" for the device's performance is established by conformance to recognized industry standards (ASTM D 6319-00a (2005)e1, ASTM D6124-06, ISO 10993 Part 10, 16CFR 1500.41, 16CFR 1500.3). These standards define the acceptable range or limits for dimensions, strength, freedom from holes, residual powder, and biological response (skin irritation/sensitization).
8. The sample size for the training set
This information is not applicable. This device is not an AI/machine learning model, so there is no concept of a "training set."
9. How the ground truth for the training set was established
This information is not applicable for the same reason as in point 8.
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