Search Results

The Nitrile Disposable Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl, is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. The tested drugs are: Chemotherapy drug Concentration Minimum Breakthrough Detection Time Bleomycin sulfate (15.0 mg/ml 15,000 ppm) 240 min Carboplatin (10.0 mg/ml 10,000 ppm) 240 min Carmustine (BCNU) (3.3mg/mL 3,300 ppm) 26.7 Cisplatin (1.0 mg/mL 1,000 ppm) 240 min Cyclophosphamide (20.0 mg/mL 20,000 ppm) 240 min Cytarabine (Cytosine) (100.0 mg/mL 100,000 ppm) 240 min Dacarbazine (10.0 mg/mL 10,000 ppm) 240 min Doxorubicin HCL (2.0 mg/mL 2,000 ppm) 240 min Etoposide (Toposar) (20.0 mg/mL 20,000 ppm) 240 min Fluorouracil (5 Flu) (50.0 mg/mL 50,000 ppm) 240 min Idarubicin (1.0 mg/ml 1,000 ppm) 240 min Ifosfamide (50.0 mg/mL 50,000 ppm) 240 min Mechlorethamine HCL (1.0 mg/ml 1,000 ppm) 240 min Methotrexate (25.0 mg/mL 25,000 ppm) 240 min Mitomycin C (0.5 mg/mL 500 ppm) 240 min Mitoxantrone HCL (2.0 mg/mL 2,000 ppm 240 min Paclitaxel (6.0 mg/mL 6,000 ppm) 240 min Thiotepa (10.0 mg/mL 10,000 ppm) 37.6 Vincristine Sulfate (1.0 mg/mL 1,000 ppm 240 min Non Chemotherapy Drug MESNA (100.0 mg/mL 100,000 ppm) 240 min Trisenox (1.0 mg/ml 1,000 ppm) 240 min Fentanyl Citrate Injection (100 mcg/2mL) 240 min Note: Carmustine and Thiotepa have extremely low permeation times of 26.7 and 37.6 minutes respectively. Warning: Do Not Use with Carmustine, Thiotepa.

The Nitrile Disposable Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl are non-sterile, single use only, disposable examination gloves intended for medical purposes to be worn by examiners to prevent contamination between the patient and the examiner. The gloves are blue color, powder free, nitrile ambidextrous gloves are offered in four sizes, small, medium and large, extra-large, packed in a paper box. The gloves are designed and manufactured in accordance with the ASTM D6319-19 standard and are tested for use with chemotherapy drugs and Fentanyl per ASTM D6978-05 (Reapproved 2019). The gloves are as same as the Nitrile disposable examination gloves (Model D5000) cleared under K212578 also produced by Xingyu Medical Tech Co., Ltd. The materials and the manufacturing process technology are the same. The proposed device is increased test of Chemotherapy Drug and Fentanyl. Testing has been conducted on the proposed device passed as per ASTM D6978-05 (Reapproved 2019).

This document is a 510(k) Premarket Notification from the FDA regarding "Nitrile Disposable Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl". It does not describe an AI medical device. Therefore, I cannot provide an answer based on the prompt's request for AI-specific acceptance criteria and study details.

The document focuses on the physical and chemical properties of medical gloves, their resistance to certain drugs, and their biocompatibility, which are assessed through standard laboratory testing methods, not AI performance studies.

Ask a specific question about this device

The Medical Face Mask is intended to be worn to protect both the patient and healthcare persomel from transfer of microorganisms, body fluids and particulate material. These face masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This a single use, disposable device(s), provided non-sterile.

The Proposed Device Medical Face Mask (Model: M001) is available in white, blue and black colors, and flat pleated type mask, utilizing ear loops way for wearing, and it has Nose clips design for fitting the face mask around the nose. The proposed device is manufactured with three layers, the inner and outer layers are made of spun-bond polypropylene, and the middle layer is made of melt blown polypropylene filter. The model of proposed device, ear loops, is held in place over the user's mouth and nose by two elastic ear loops welded to the face mask. The elastic ear loops are made of Polyester and Spandex. The nose piece contained in the proposed device is in the layers of face mask to allow the user to fit the face mask around their nose, which is made of Metal Core Plastic (Iron wire & Polypropylene). The proposed device(s) are sold non-sterile and are intended to be single use, disposable device.

The provided text describes the 510(k) premarket notification for a Medical Face Mask (Model: M001). This document focuses on demonstrating substantial equivalence to a legally marketed predicate device (K211631) through non-clinical performance testing and biocompatibility assessments, rather than AI/ML algorithm performance.

Therefore, many of the requested criteria related to AI/ML device performance (like MRMC studies, standalone algorithm performance, number of experts for ground truth, sample size for training sets, etc.) are not applicable to this submission, as it pertains to a physical medical device (face mask) and not an AI-powered diagnostic or assistive technology.

Here's the information that can be extracted and a clear indication of what is not applicable:

1. A table of acceptance criteria and the reported device performance

Ask a specific question about this device

The Nitrile disposable examination gloves (Tested for use with Chemotherapy Drugs) are a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. Summarized in Table 1 below, the proposed device was tested for use with chemotherapy drugs per ASTM D6978-05 (2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.

The Nitrile disposable examination gloves (Tested for use with Chemotherapy Drugs) are nonsterile, single use only, disposable examination gloves intended for medical purposes to be worn by examiners to prevent contamination between the patient and the examiner. The gloves are blue, powder free, nitrile gloves. The gloves are offered in sizes small, medium, large, extra large, and packaged in a color paper box. The gloves are designed and manufactured in accordance with the ASTM D6319-19 standard and are tested for use with chemotherapy drugs per ASTM D6978-05(2019).

This document is a 510(k) Premarket Notification for Nitrile disposable examination gloves (Tested for use with Chemotherapy Drugs). As such, it focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than on the performance of an AI/ML powered medical device. Therefore, a significant portion of the requested information (points 2-5, 7-9) about the study design for an AI/ML powered device is not applicable to this document.

Here's the relevant information based on the provided text:

1. Table of Acceptance Criteria and the Reported Device Performance

The device meets acceptance criteria across several tests, primarily based on ASTM standards.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size for Test Set:
  • For the Watertightness Test (detection of holes), the sample size was 125 gloves for a batch size of 35,000.
  • For other physical and chemotherapy permeation tests, the specific sample sizes are not explicitly stated within the provided text, but they were conducted "per ASTM D6319-19" and "per ASTM D6978-05(2019)", implying adherence to the sample size requirements of those standards.
• Data Provenance: The document does not explicitly state the country of origin of the test data (e.g., where the independent labs performing the tests are located) or whether the studies were retrospective or prospective, though performance testing is inherently prospective for a new device. The submitter is XINGYU MEDICAL TECH CO.,LTD. from China.

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. This document describes performance testing of medical gloves against established ASTM and ISO standards for physical properties, chemotherapy permeation, and biocompatibility. Ground truth in this context is determined by laboratory measurements and chemical/biological assays, not by expert interpretation of images or clinical data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable. As mentioned above, the assessment criteria are based on objective, standardized laboratory tests, not subjective expert judgment that would require an adjudication method.

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. This document is for medical gloves, not an AI/ML powered device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not applicable. This document is for medical gloves, not an AI/ML powered device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the device's performance is established by objective measurements and observations derived from standardized laboratory tests:

• Physical Measurements: Length, width, and thickness measured according to ASTM D6319-19.
• Mechanical Property Tests: Tensile strength and elongation measured before and after aging according to ASTM D6319-19.
• Watertightness Test: Detection of holes by visual inspection after inflation or water fill, according to ASTM D5151-19.
• Chemical Analysis: Residual powder measured according to ASTM D6124-06 (2017).
• Permeation Testing: Breakthrough time of chemotherapy drugs measured using a sensitive analytical method (e.g., gas chromatography, liquid chromatography) to detect the permeation of the drug through the glove material (as per ASTM D6978-05(2019)).
• Biocompatibility Assays: In-vitro or in-vivo tests to assess skin irritation (e.g., patch tests on animals or human volunteers), dermal sensitization (e.g., guinea pig maximization test), and acute systemic toxicity (e.g., intravenous or oral administration to animals), according to ISO 10993-10 and ISO 10993-11.

8. The sample size for the training set

This information is not applicable. This document does not describe an AI/ML powered device, so there is no "training set."

9. How the ground truth for the training set was established

This information is not applicable. This document does not describe an AI/ML powered device, so there is no "training set" or ground truth establishment for such a set.

Ask a specific question about this device

Nitrile disposable examination gloves are non-sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Nitrile films form a barrier to prevent contamination between patient and examiner. The nitrile rubber is water tight under normal conditions of use. It's tensile properties cause it to conform to the hand, allowing movements necessary for a medical procedure. The glove is manufactured in accordance with the requirements of ASTM D6319 and ASTM D5151.

This document describes the performance testing and acceptance criteria for Nitrile disposable examination gloves. It is important to note that this is a physical medical device (gloves), not an AI/software-based medical device. Therefore, many of the requested criteria in your prompt (e.g., number of experts for ground truth, MRMC study, training set ground truth) are not applicable to this type of device.

Here's the information extracted from the provided text, focusing on the relevant criteria for a physical device:

1. Table of Acceptance Criteria and Reported Device Performance

The performance data is primarily presented in a comparative table against ASTM standards.

2. Sample Size for the Test Set and Data Provenance

• Sample Size for Test Set:
  • For the Watertightness Test (detection of holes), the sample size is explicitly stated: 125 samples for a batch size of 35,000.
  • For other tests (Physical Dimensions, Physical Properties, Powder Residual, Biocompatibility), specific sample sizes are not detailed in the provided document. The document refers to meeting ASTM and ISO standards, which would implicitly define testing sample sizes.
• Data Provenance: The tests are described as "bench testing" and "non-clinical performance data." The company performing the tests is XINGYU MEDICAL TECH CO.,LTD., located in China. The data is retrospective in the context of the 510(k) submission, meaning the tests were completed prior to submission.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

• Not Applicable. This is a physical device, and performance is measured against established international standards (ASTM, ISO) for physical and chemical properties, not by human expert interpretation of data or images. The "ground truth" is defined by the technical specifications and test methodologies within these standards.

4. Adjudication Method for the Test Set

• Not Applicable. As this is a physical device, testing is quantitative and follows specific, standardized protocols. There is no human adjudication process involved in the interpretation of physical test results. Results are either "Pass" or "Fail" based on whether they meet the numerical acceptance criteria of the standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• No. An MRMC study is relevant for AI/imaging devices where human reader performance is being evaluated with and without AI assistance. This is a physical medical device (gloves), so an MRMC study is not applicable. The document explicitly states: "Clinical data is not needed to demonstrate the performance or safety of the subject glove as compared to the predicate device or applicable standards."

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not Applicable. This refers to AI algorithm performance. This product is a physical glove, not an algorithm. The testing described is "standalone" in the sense that it's testing the inherent properties of the glove itself against defined standards.

7. The Type of Ground Truth Used

• The ground truth for this device's performance relies on established international consensus standards (ASTM D6319-19, ASTM D5151-19, ASTM D6124-06(2017), ISO 10993-10: 2010, ISO 10993-11: 2017, ASTM D7161-16). These standards define the acceptable physical dimensions, mechanical properties (tensile strength, elongation), barrier integrity (pinholes), chemical properties (powder residual), and biocompatibility.

8. The Sample Size for the Training Set

• Not Applicable. This refers to AI algorithm training data. This product is a physical glove and does not involve machine learning or a "training set."

9. How the Ground Truth for the Training Set was Established

• Not Applicable. As there is no training set for a physical device like this, there is no ground truth established in this context.

Ask a specific question about this device