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Beijing Reagent Latex Products Co., Ltd. Nitrile Examination Gloves are disposable devices intended for medical purpose that are worn on the examiner's hand to prevent contamination between patient and examiner.

The Beijing Reagent Latex Products Co., Ltd. Nitrile Examination Gloves are powder-free Class I patient examination gloves are manufactured from nitrile and are blue in color. The examination gloves are intended for medical purpose, will be worn on the examiner's hand, and will be available in four sizes (Small, Medium, Large, and Extra-Large).

The provided document describes the acceptance criteria and the results of non-clinical testing for the Beijing Reagent Latex Products Co., Ltd. Nitrile Examination Gloves (K211515).

Here's the breakdown of the requested information:

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

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 non-clinical test. It refers to compliance with ASTM and ISO standards, which typically specify sampling plans. The data provenance is implied to be from the manufacturer's testing of the subject device (Beijing Reagent Latex Products Co., Ltd.), which is located in Beijing, China. The testing appears to be prospective as it was conducted for this specific 510(k) 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 information is not applicable to the non-clinical tests described. The ground truth for these tests is established by objective physical and chemical testing methods as defined by the ASTM and ISO standards, rather than expert consensus on medical images or clinical data.

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

This information is not applicable to the non-clinical tests described. Adjudication methods are typically used for subjective assessments or when discrepancies arise in expert interpretations of medical data, which is not the case here.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not performed. The document states, "This section is not applicable to this Premarket Notification 510(k); there was no clinical testing conducted on this product." This device is a medical glove, and its performance is evaluated through physical and biocompatibility testing, not through AI assistance for human readers.

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 medical glove, not an algorithm or AI-based diagnostic tool. Its performance is entirely standalone in its physical and biological properties.

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

The ground truth for these non-clinical tests is based on objective measurements and standardized testing protocols defined by international standards (ASTM and ISO). For example:

• Physical properties (length, width, thickness, tensile strength, elongation) are determined by direct measurement.
• Hole detection is determined by water leak testing.
• Powder residue is determined by gravimetric analysis.
• Biocompatibility tests (skin irritation, sensitization, cytotoxicity, systemic toxicity) are performed in vitro or in vivo according to specified biological testing methods, and the results are compared against defined biological responses.

8. The sample size for the training set

This information is not applicable. The device is a physical product (medical glove), 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 there is no training set for this device.

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This Powdered Latex Surgical Glove is a disposable device made of natural rubber latex material that bears powder to facilitate donning, and it is intended to be worn on the hands, usually in surgical setting, to provide a barner against potentially infectious materials and other contaminants.

Powdered Latex Surgeon's Glove

This is a 510(k) premarket notification for a powdered latex surgeon's glove. It is a traditional medical device submission and does not describe AI/ML software. Therefore, I cannot provide the requested information about acceptance criteria, study details, and AI/ML specific aspects.

The document discusses the regulatory classification of the device (Class I), general controls provisions, and the FDA's determination of substantial equivalence to legally marketed predicate devices. It also lists the "Indications for Use" for the glove, stating its purpose as a barrier against infectious materials in a surgical setting.

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A Powder Free Latex Surgical Glove is a disposable device intended in surgical settings for medical purpose that is worn on the hand to provide a barrier against potentially infectious materials and other contaminants.
A surgeon's glove is a device made of natural or synthetic rubber intended to be worn by the are and A surgeon's grove 15 a device intraction wound from contamination. (21CFR 878.4460)

Class I Surgeon's Glove (Powder Free) 79KGO that meets all the requirement of ASTM D3577.

Here's a breakdown of the acceptance criteria and study information for the BEIJING REAGENT LATEX PRODUCTS CO., LTD. "SNOW LOTUS" Powder Free Surgeon's Glove, based on the provided text:

Acceptance Criteria and Reported Device Performance

Study Details

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

   • The document does not specify the exact sample size for the test set used for each parameter. It refers to "Inspection Level" and "AQL" (Acceptable Quality Limit) as per ASTM D3577 standards, implying that a statistically relevant sample size was drawn and tested according to these quality standards.
   • Data Provenance: The tests were conducted by BEIJING REAGENT LATEX PRODUCTS CO., LTD., in P.R. CHINA. The data is retrospective, presented as a summary of compliance with recognized standards.

2. 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 physical and chemical tests of medical devices like gloves, "ground truth" is typically established through adherence to specified test methods and equipment calibration as defined by standards like ASTM D3577, rather than human expert consensus on interpretations.

3. Adjudication method for the test set:

   • This information is not applicable in the context of physical and chemical testing of medical devices. Adjudication methods like 2+1 or 3+1 are relevant for subjective assessments, typically in image-based diagnostic studies. For these gloves, adherence to quantitative measurements against established standards is the method of assessment.

4. 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 study was not done. This type of study is specifically for evaluating AI in diagnostic contexts, usually involving human readers interpreting medical images. This document describes a physical medical device (surgical gloves), not an AI diagnostic tool.

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

   • Not applicable. This document describes a physical medical device. There is no AI algorithm being evaluated for standalone performance.

6. The type of ground truth used:

   • The ground truth used is defined by internationally recognized consensus standards and requirements, specifically ASTM D3577-00 for most parameters, and FDA requirements for Biocompatibility and Pinholes. This represents a set of objectively measurable physical and chemical properties.

7. The sample size for the training set:

   • Not applicable. This document describes a physical medical device, not a machine learning model, so there is no concept of a "training set."

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

   • Not applicable. As there is no training set for a machine learning model, this question does not apply.

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Ask a specific question about this device