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The Nitrile Disposable Examination Glove, 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.

Gloves have been tested for use with chemotherapy drugs and Fentanyl Citrate using ASTM D6978-05.

The tested chemotherapy 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) 13.2

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) 13.1

Vincristine Sulfate (1.0 mg/mL 1,000 ppm >240 min

The tested non-chemotherapy drugs are:

Fentanyl Citrate Injection (100 mcg/2mL) >240 min

MESNA (100.0 mg/mL 100,000 ppm) >240 min

Trisenox (1.0 mg/ml 1,000 ppm) >240 min

Note: Carmustine and Thiotepa have extremely low permeation times of 13.2 and 13.1 minutes respectively.

Warning: Do Not Use with Carmustine, Thiotepa

The Nitrile Disposable Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl (D5000) 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 six sizes, extra small, small, medium, large, extra-large and extra extra-large, packed in a paper box.

The gloves are designed and manufactured in accordance with the ASTM D6319 standard and are tested for use with chemotherapy drugs and Fentanyl per ASTM D6978 standard.

This document is a 510(k) Premarket Notification from the FDA regarding "Nitrile Disposable Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl (D5000)". It outlines the device's characteristics, indications for use, and a comparison to a predicate device, focusing on non-clinical testing.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

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

The document provides multiple tables summarizing the performance and comparison of the proposed device to predicate devices. The primary table serving this purpose is "Table 3 Performance comparison" and the table that includes "Test Method," "Purpose," "Acceptance Criteria," and "Results" on Page 13.

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 specify the exact sample sizes used for each physical or chemical test. It references ASTM standards, which would typically define sampling plans. For instance, for Freedom from Holes, it mentions "sampling level of G-1, AQL 2.5," which refers to specific statistical sampling plans within ASTM D5151, but not the explicit number of gloves tested.

The data provenance is from non-clinical tests conducted to relevant ASTM and ISO standards. The Applicant, Shandong Xingyu Gloves Co., Ltd., is located in China, suggesting the tests were likely conducted there or by affiliated labs. The testing appears to be prospective as it was done specifically to evaluate the performance of this new device for submission.

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 document describes a device (gloves) and its performance under various physical and chemical stress tests, not imaging or diagnostic AI. Therefore, the concept of "experts establishing ground truth" in the medical image interpretation sense (e.g., radiologists) is not applicable here. The "ground truth" for the performance claims (e.g., tensile strength, breakthrough time) is established by adherence to the specified and validated ASTM and ISO laboratory test methods and their defined measurement protocols. The experts involved would be the qualified laboratory technicians and chemists performing these standardized tests. Their qualifications are implicitly that they are capable of performing these standardized tests correctly.

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

Adjudication methods like "2+1" or "3+1" are typically used in clinical studies, especially those involving subjective human interpretation of data (e.g., medical images), where disagreements between readers need to be resolved by a third or fourth expert. Since this document describes non-clinical, objective laboratory testing of physical and chemical properties, an adjudication method as typically understood in a multi-reader clinical study is not applicable. The results are directly measured by instruments and adherence to test protocols.

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, an MRMC comparative effectiveness study was not conducted. This is a 510(k) submission for medical gloves, based on non-clinical performance testing against established standards, not a diagnostic AI device requiring human reader interaction studies.

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

No, a standalone algorithm performance study was not done. This is a physical medical device, not a software algorithm.

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

The "ground truth" for this device's performance claims is based on objective measurements obtained through standardized laboratory test methods (ASTM and ISO standards). For example:

• Physical properties (tensile strength, elongation): Measured in a lab according to ASTM D6319.
• Freedom from holes: Tested by inflation or water leak methods per ASTM D5151.
• Residual powder: Measured gravimetrically per ASTM D6124.
• Permeation by chemotherapy drugs/Fentanyl: Measured chromatographically by detecting breakthrough according to ASTM D6978.
• Biocompatibility: Evaluated in in vitro or in vivo models for specific biological endpoints (irritation, sensitization, systemic toxicity) following ISO 10993 standards.

The ground truth is therefore defined by the quantitative and qualitative results of these standardized, validated test procedures.

8. The sample size for the training set.

There is no training set mentioned or implied because this is not an AI/machine learning device. The device's performance is demonstrated through standard laboratory testing, not by training a model on a dataset.

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

As there is no training set, this question is not applicable.

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The Medical Face Mask is intended to be worn to protect both the patient and healthcare personnel 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, M2002, M3001, M3002) are available in 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(s) submitted meet both the performance requirements of level 2 and 3 specified in ASTM F2100-19. Level 2 blue mask is model number M2001; Level 2 black mask is model number M2002; Level 3 blue mask is model number M3001; Level 3 black mask is model number M3002; 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 document is a 510(k) Summary for a Medical Face Mask (K221272). It details non-clinical tests to demonstrate substantial equivalence to a predicate device, rather than a clinical effectiveness study. Therefore, some of the requested information (like effect size of AI assistance, expert qualifications, or adjudication methods for ground truth) is not applicable or cannot be extracted from this particular document.

Here's the available information based on the document:

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

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Xingyu Powder Free Nittile Patient Examination Gloves, White Color is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between the 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 Nitrile glove acts as a barrier to prevent contamination between patient and examiner. The glove is manufactured in accordance with the requirements of ASTM D6319-10(Reapproved 2015) and ASTM D5151-06(Reapproved 2015).

The document describes the conformity of the Xingyu Nitrile Powder Free Patient Examination Gloves, White color to established standards for patient examination gloves. It does not describe an AI medical device or a study involving human readers or AI assistance. Therefore, many of the requested elements (multi-reader multi-case study, AI-related information, expert qualifications, adjudication methods) are not applicable.

Here's the information that can be extracted and formatted based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance:

• The document does not explicitly state the sample sizes for each specific test (e.g., how many gloves were tested for pinholes, or how many animals for biocompatibility). It generally refers to "bench testing."
• Data Provenance: The tests were conducted by Shandong Xingyu Gloves Co., Ltd (China). The data implicitly comes from internal testing by the manufacturer. It is retrospective as it was completed before the 510(k) submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. This is not a study involving ground truth established by human experts. The "ground truth" for these tests are the established ASTM and ISO standards for glove performance.

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

• Not applicable. There was no expert adjudication process for these types of physical and chemical tests. The results are based on objective measurements against defined 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:

• Not applicable. This document is for patient examination gloves, not an AI or imaging device, and therefore no MRMC study was performed.

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

• Not applicable. This document is for patient examination gloves, not an AI or algorithm-based device.

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

• The "ground truth" for the device's performance is objective measurement against pre-defined performance standards and regulatory requirements (ASTM D6319-10, ASTM D5151-06, ASTM D6124-06, ISO 10993-10, and 21 CFR 800.20 related to pinholes).

8. The sample size for the training set:

• Not applicable. This is not a machine learning or AI device that requires a training set.

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

• Not applicable. This is not a machine learning or AI device that requires a training set.

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Xing Yu Powder Free Nitrile Patient Examination Gloves, Blue Color is a 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 Nitrile glove acts as a barrier to prevent contamination between patient and examiner. The glove is manufactured in accordance with the requirements of ASTM D6319 and ASTM D5151.

The provided document is a 510(k) Premarket Notification for a medical device (Xingyu Powder Free Nitrile Patient Examination Gloves, Blue Color). It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study of the device's clinical performance against detailed acceptance criteria in the context of, for example, an AI/ML diagnostic device.

Therefore, the specific information requested in your prompt regarding acceptance criteria and a study to prove the device meets them (especially points 2-9, which relate to diagnostic performance studies) is not applicable in the context of this document.

However, I can extract information related to the performance specifications used to demonstrate substantial equivalence of the gloves, which are akin to acceptance criteria based on established standards for medical examination gloves.

Here's a breakdown of what can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical)

The device's performance is measured against ASTM standards and FDA regulations for examination gloves. The "acceptance criteria" here are the requirements of these standards. The "reported device performance" indicates whether the device met these criteria.

Non-Applicable Information for this Document:

The following points are typically relevant for diagnostic devices, especially those incorporating AI/ML. This 510(k) for examination gloves does not contain this type of information.

2. Sample size used for the test set and the data provenance: Not applicable. This document refers to bench testing of physical properties and biocompatibility, not a test set of data for diagnostic performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for diagnostic classifications is not established for this device.
4. Adjudication method for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable. This is not a diagnostic device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device (gloves), not an algorithm.
7. The type of ground truth used: Not applicable. The "ground truth" for gloves is adherence to material, physical, and biocompatibility standards.
8. The sample size for the training set: Not applicable. There is no AI/ML training set for this device.
9. How the ground truth for the training set was established: Not applicable.

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