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510(k) Data Aggregation
(63 days)
Lingshi Hongruida Health Protection Technology Co., Ltd.
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, Fentanyl Citrate and Other Select Drugs using ASTM D6978-05(2019)
Powder Free Nitrile Examination Gloves (Violet, Black, Green), Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Select Other Drugs 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 and have been tested for resistance to permeation by chemotherapy drugs, Fentanyl Citrate and Select Other Drugs as per ASTM D6978. The gloves are single use, disposable, and non-sterile.
Here's a breakdown of the acceptance criteria and study information for the Powder Free Nitrile Examination Gloves:
1. Table of Acceptance Criteria and Reported Device Performance:
| Methodology | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| ASTM D6319- 19 | To determine the length of the gloves | XS: ≥ 220 mm; S: ≥ 220 mm; M: ≥ 230 mm; L: ≥ 230 mm; XL: ≥ 230 mm; XXL: ≥ 230 mm | Pass |
| ASTM D6319- 19 | To determine the Physical Dimensions (Palm Width) | XS: 70±10mm; S: 80±10mm; M: 95±10mm; L:110±10mm; XL:120±10mm; XXL:130±10mm | Pass |
| ASTM D6319- 19 | To determine the Physical Dimensions (Thickness) | Finger: 0.05mm (min); Palm: 0.05mm (min) | Pass |
| ASTM D6319- 19, ASTM D412-16(2021) | To determine the Physical Properties | Tensile Strength (Min 14 MPa) and Elongation (Before Aging 500% and after aging 400%) Min | Pass |
| ASTM D6319- 19, ASTM D6124-06 (2022) | To determine the Powder Residue | Max 2mg/glove | Pass |
| ISO 10993 Part 10-2021 | Skin Sensitization Testing | Under the conditions of the study, the device is not a sensitizer | Under the conditions of this protocol, the test article did not elicit a sensitization response. |
| ISO 10993 Part 23-2021 | Skin irritation Testing | Under the conditions of the study, the device is not an irritant | The test result showed that the requirements of the ISO Intracutaneous Reactivity Test have been met by the test article. |
| ISO 10993-5:2009 | Cytotoxicity testing | No Cytotoxicity reactivity | The test article is considered cytotoxic under the conditions of this test. Cytotoxicity concern was addressed by Acute Systemic Injection Test. |
| ISO 10993-11:2017 | Acute systemic toxicity study | No systemic toxicity | The test result indicates that the requirements of the ISO Acute Systemic Injection Test have been met by the test article. |
| ASTM D6978-05 (Reapproved 2019) | Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs | Minimum Breakthrough Detection Time for various chemotherapy drugs, Fentanyl Citrate, and other select drugs (specific values listed in the "Indications for Use" and "Chemotherapy Permeation, Fentanyl Citrate, and Select Other Drugs Comparison Claim" tables). | See detailed breakthrough times in original document, with most being >240 minutes, except for Carmustine and Thiotepa which have lower breakthrough times (e.g., Carmustine 11.7-15.3 min, Thiotepa 15.4-36.4 min). |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the sample sizes used for each specific test (e.g., number of gloves tested for length, width, thickness, etc.). However, the tests were conducted according to established ASTM and ISO standards, which typically specify appropriate sample sizes for such evaluations.
- Provenance: This information is not directly stated. The tests were conducted according to international standards (ASTM and ISO). The manufacturing company is Lingshi Hongruida Health Protection Technology Co., Ltd. located in Jinzhong, Shanxi, China. It is highly probable that the testing was performed in a laboratory either in China or an accredited facility capable of performing these international standard test methods. The study appears to be retrospective as it involves the testing of a finished device against established performance criteria.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
This information is not applicable. The device is a physical product (nitrile gloves), and its performance is evaluated against objective, measurable criteria defined by established engineering and biological safety standards (ASTM and ISO), not subjective expert interpretation of medical images or patient data. The "ground truth" is derived from direct measurements and laboratory analyses, not expert consensus.
4. Adjudication Method for the Test Set:
This information is not applicable. As the testing involved objective physical and chemical performance standards, there was no need for expert adjudication. The results were quantifiable measurements against pre-defined acceptance criteria.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No, an MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic or screening devices involving human interpretation of medical data (e.g., radiologists reading images). This product is a medical glove, and its effectiveness is determined through standardized physical, chemical, and biological testing.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Yes, the studies conducted are standalone performance evaluations of the physical glove itself, without any human-in-the-loop component in the evaluation of its core performance characteristics (e.g., tensile strength, resistance to chemical permeation, cytotoxicity). The testing directly measured the attributes of the glove.
7. The Type of Ground Truth Used:
The ground truth for this device's performance evaluation is based on established objective technical standards and laboratory measurements. Specifically:
- Physical properties (length, width, thickness, tensile strength, elongation) are measured directly according to ASTM D6319-19 and ASTM D412-16(2021).
- Chemical resistance (chemotherapy drug permeation) is measured according to ASTM D6978-05 (Reapproved 2019).
- Biocompatibility (skin sensitization, irritation, cytotoxicity, systemic toxicity) is evaluated through laboratory tests following ISO 10993 series standards.
- Freedom from holes is evaluated by ASTM D5151-19.
- Powder residue is evaluated by ASTM D6124-06 (Reapproved 2022).
8. The Sample Size for the Training Set:
This information is not applicable. This device is a physical product, not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning. The manufacturing process and quality control would involve statistical sampling typical for medical device production.
9. How the Ground Truth for the Training Set was Established:
This information is not applicable, as there is no training set for this type of device.
Ask a specific question about this device
(52 days)
Lingshi Hongruida Health Protection Technology Co., Ltd.
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, Fentanyl Citrate, and select other drugs using ASTM D6978-05(2019)
Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, and select other drugs 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, Fentanyl Citrate, and select other drugs as per ASTM D6978-05(2019). The gloves are single use, disposable, and non-sterile.
The provided document describes the acceptance criteria and performance of "Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, and select other drugs" (K240051).
Here's the breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Test Performed | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Physical Dimensions | ||
| Length | Minimum 220mm for size XS and S, 230mm for size M, L, XL, XXL (ASTM D6319-19) | Pass |
| Palm Width (size) | XS: 70±10 mm, S: 80±10 mm, M: 95±10 mm, L: 110±10 mm, XL: 120±10 mm, XXL: 130±10 mm (ASTM D6319-19) | Pass |
| Thickness | Finger: 0.05mm (min), Palm: 0.05mm (min) (ASTM D6319-19) | Pass |
| Physical Properties | ||
| Tensile Strength & Elongation (Before Aging) | Tensile Strength: 14MPa, min; Elongation: 500%, min (ASTM D6319-19, ASTM D412-16(2021)) | Pass |
| Tensile Strength & Elongation (After Accelerated Aging) | Tensile Strength: 14MPa, min; Elongation: 400%, min (ASTM D6319-19, ASTM D412-16(2021)) | Pass |
| Barrier Integrity | ||
| Watertight (1000ml) | G-I, AQL 2.5 (21 CFR 800.20, ASTM D5151-19) | Pass |
| Powder Residue | Max 2mg/glove (ASTM D6319-19, ASTM D6124-06(2017)) | Pass |
| Chemotherapy Drugs & Opioid Drug Permeation | Minimum Breakthrough Detection Time (BDT) for various chemotherapy drugs and Fentanyl Citrate. Accepted values differ by drug, but generally, longer BDT indicates better performance. Specific acceptance criteria are not explicitly listed as a single value but are implied by the reported BDTs (e.g., >240 minutes for many drugs, with lower specific values for Carmustine and Thiotepa which are cautioned against). | See specific BDT values in the tables below for each drug. Notably, Carmustine: 29.1 minutes, Thiotepa: 78.3 minutes. All other listed drugs exhibit >240 minutes BDT. Fentanyl Citrate: >240 minutes. |
| Biocompatibility | ||
| Irritation and Skin Sensitization | Non-sensitization and Non-irritation (ISO 10993-10 & -23) | Non-sensitization and Non-irritation |
| Cytotoxicity | Cytotoxicity reactivity (ISO 10993-5:2009) | Showed potential toxicity to L929 cells, but concern addressed by acute systemic toxicity testing. |
| Acute systemic toxicity study | No adverse biological reaction (ISO 10993-11:2017) | No evidence of acute systemic toxicity. |
Chemotherapy, Fentanyl Citrate & other drugs Permeation Comparison (Proposed Device K240051):
| Tested Chemotherapy Drug and Concentration | Minimum Breakthrough Detection Time in Minutes |
|---|---|
| Bleomycin Sulfate 15mg/ml (15000 ppm) | >240 |
| Busulfan 6mg/ml (6,000 ppm) | >240 |
| Carboplatin 10mg/ml (10,000 ppm) | >240 |
| Carmustine 3.3 mg/ml (3,300 ppm) | 29.1 |
| Cisplatin 1mg/ml (1,000 ppm) | >240 |
| Cyclophosphamide 20mg/ml (20,000 ppm) | >240 |
| Cytarabine, 100 mg/ml (100,000 ppm) | >240 |
| Dacarbazine 10 mg/ml (10,000 ppm) | >240 |
| Daunorubicin HCL, 5 mg/ml (5,000 ppm) | >240 |
| Docetaxel , 10 mg/ml (10,000 ppm) | >240 |
| Doxorubicin HCL, 2 mg/ml (2,000 ppm) | >240 |
| Epirubicin HCL, 2 mg/ml (2,000 ppm) | >240 |
| Etoposide, 20 mg/ml (20,000 ppm) | >240 |
| Fludarabine Phosphate, 25 mg/ml (25,000 ppm) | >240 |
| Fluorouracil, 50mg/ml (50,000ppm) | >240 |
| Gemcitabine HCL, 38mg/ml (38,000ppm) | >240 |
| Idarubicin HCL, 1mg/ml (1,000ppm) | >240 |
| Ifosfamide, 50mg/ml (50,000ppm) | >240 |
| Irinotecan HCL, 20mg/ml (20,000ppm) | >240 |
| Mechlorethamine HCI, 1mg/ml (1,000ppm) | >240 |
| Melphalan HCL, 5mg/ml (5,000ppm) | >240 |
| Methotrexate, 25mg/ml (25,000ppm) | >240 |
| Mitomycin C, 0.5mg/ml (500ppm) | >240 |
| Mitoxantrone HCL, 2mg/ml (2,000ppm) | >240 |
| Oxaliplatin, 5mg/ml (5,000ppm) | >240 |
| Paclitaxel, 6mg/ml (6,000ppm) | >240 |
| Paraplatin, 10mg/ml (10,000ppm) | >240 |
| Rituximab, 10mg/ml (10,000ppm) | >240 |
| Thiotepa, 10mg/ml (10,000ppm) | 78.3 |
| Topotecan HCL, 1mg/ml (1,000ppm) | >240 |
| Trisenox (Arsenic Trioxide), 1mg/ml (1,000ppm) | >240 |
| Velcade (Bortezomib), 1mg/ml (1,000ppm) | >240 |
| Vincristine Sulfate, 1mg/ml (1,000ppm) | >240 |
| Fentanyl Citrate Injection (100 mcg/2ml) | >240 |
| Chloroquine 50mg/ml (50,000ppm) | >240 |
| Cyclosporin A 100 mg/ml (100,000 ppm) | >240 |
| Retrovir, 10mg/ml (10,000ppm) | >240 |
Warning: Do not use with Carmustine and Thiotepa due to "extremely low permeation times" (29.1 minutes and 78.3 minutes, respectively).
2. Sample size used for the test set and the data provenance:
- The document primarily refers to standard ASTM and ISO test methodologies for device performance (e.g., ASTM D6319-19, ASTM D6978-05(2019), ISO 10993 series). These standards typically define the sample sizes required for each specific test to ensure statistical validity.
- Data Provenance: The document states "Non-clinical tests were conducted to verify that the proposed device met all design specifications." The tests were performed by Lingshi Hongruida Health Protection Technology Co., Ltd. located in China. The data is retrospective in the sense that the testing was performed and then submitted with the 510(k) application. Specific details on exact sample sizes (e.g., number of gloves tested for each characteristic) within each standard are not explicitly detailed in this summary for every test. However, the chemotherapy drug permeation testing likely involved multiple samples per drug as per ASTM D6978.
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 device is a physical medical device (examination glove) and the testing involved objective, quantitative, and standardized measurements according to established consensus standards (ASTM, ISO). There were no "experts" establishing a "ground truth" in the way they would for, say, image interpretation or clinical diagnosis. The ground truth for performance relied on the specified chemical and physical property measurements.
4. Adjudication method for the test set:
- This is not applicable. As mentioned above, the testing involved objective physical and chemical measurements governed by established standards, not subjective interpretations 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:
- This is not applicable. This device is an examination glove, not an AI-powered diagnostic tool or imaging software. Therefore, no MRMC study or AI-related comparative effectiveness study was performed or is relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- This is not applicable. This device is an examination glove and does not involve any algorithm or AI for standalone performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth for this device's performance is based on objective measurements against established performance standards and chemical permeation resistance thresholds.
- For physical properties (length, thickness, tensile strength, elongation, watertightness, powder content): The ground truth is the quantitative measurement compared against the specified ASTM standard values.
- For chemical permeation (chemotherapy drugs, Fentanyl Citrate): The ground truth is the experimentally determined Minimum Breakthrough Detection Time (BDT) in minutes, measured according to ASTM D6978-05(2019).
- For biocompatibility (irritation, sensitization, cytotoxicity, acute systemic toxicity): The ground truth is the experimental findings and conclusions derived from tests conducted under ISO 10993 series standards.
8. The sample size for the training set:
- This is not applicable. This device is a physical product, not a machine learning model, so there is no training set in the context of AI/ML.
9. How the ground truth for the training set was established:
- This is not applicable as there is no training set for this type of device.
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(5 days)
Lingshi Hongruida Health Protection Technology Co., Ltd.
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