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Nitrile Examination Gloves are disposable devices intended for medical purposes that are worn on the examiner's hand to prevent contamination between patient and examiner.

Nitrile Examination Gloves are made from nitrile butadiene rubber that covers the hand up to the wrist. They are cuffed and equally wearable on either hand, free from differentiation between the left hand and the right. The device is available in four sizes, which are S, M, L, XL. It could be selected by the user depending on the size of hand. All sizes share the same blue color. The gloves are non-sterile, powder free and are for single use only.

The provided document is a 510(k) summary for Nitrile Examination Gloves (Model: ZMG1351). It details the device's characteristics, comparison to a predicate device, and results from non-clinical testing. Here's a breakdown of the requested information:

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 specify the exact sample sizes used for each test. It simply states that "Bench tests were conducted to verify that the proposed device met all design specifications." The data provenance is not explicitly mentioned, but given the manufacturer (Wuhan Zonsen Medical Products Co.,Ltd) and contactor (Shanghai CV Technology Co., Ltd.) locations, it is highly likely the testing and data originated from China. The study appears to be retrospective in the sense that these are design verification tests performed on manufactured gloves.

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 document describes physical and biocompatibility testing of medical gloves, not an AI or diagnostic device that requires expert interpretation to establish a ground truth. The "ground truth" for these tests is based on established international standards (ASTM and ISO).

4. Adjudication Method for the Test Set

This information is not applicable for the same reason as above. The tests performed are objective measurements against predefined criteria in established 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

An MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic devices, not for basic medical devices like examination gloves.

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 physical product (nitrile examination gloves), not an algorithm or AI system.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the acceptance criteria and testing of the Nitrile Examination Gloves is based on established industry standards and protocols:

• ASTM D6319-19: Standard Specification for Nitrile Examination Gloves for Medical Application.
• ISO 10993-10: Biological Evaluation of Medical Devices - Part 10: Tests for Irritation and Skin Sensitization.
• ISO 10993-11: Biological evaluation of medical devices - Part 11: Tests for systemic toxicity.
  The tests measure physical properties and biological responses against scientifically defined and accepted limits.

8. The Sample Size for the Training Set

This information is not applicable. There is no "training set" as this is not an AI or machine learning device. The tests are for product verification and validation.

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

This information is not applicable for the same reason as above.

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Surgical Gown is intended to be worn by room personnel during surgical procedures or other invasive tests to protect both the surgical patient and operating room personnel from the transfer of microorganisms, body fluids and particulate material. This is single use, disposable device, provided sterile.

Per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities, the surgical gown met the requirements for Level 2 classification, and the reinforced surgical gowns met the requirements for Level 3 classification.

The proposed devices Surgical Gown / Reinforced Surgical Gown have two models: ZSG1005 and ZSG1006.

The proposed device Surgical Gown is model ZSG1005, its body, sleeve and belt are made of SMMS non-woven material, and cuff is made of cotton. The proposed device is available in M, L, XL sizes. This proposed device can meet the requirements for Level 2 per ANSI/AAMI PB70:2012.

The proposed device Reinforced Surgical Gown is model ZSG1006, its body, sleeve and belt are made of SMMS non-woven material, and cuff is made of cotton. The reinforced and critical zone is front chest and sleeves. This zone is reinforced with PP/PE composite breathable film. The proposed device is available in M. L. XL sizes. This proposed device can meet the requirements for Level 3 per ANSI/AAMI PB70:2012.

The proposed devices are disposable medical devices and provided in sterile.

Here's the information about the acceptance criteria and the study that proves the device meets them, based on the provided text:

Device: Surgical Gown, Reinforced Surgical Gown (Wuhan Zonsen Medical Products Co.,Ltd)

1. 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 specify the sample sizes used for each individual non-clinical test (e.g., how many surgical gowns were tested for flammability or hydrostatic pressure).
• The data provenance is from China, as the applicant is "Wuhan Zonsen Medical Products Co.,Ltd" located in Wuhan, Hubei Province, China.
• The studies were prospective as they were conducted to verify the device met design specifications for regulatory 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 this type of device (surgical gowns) and the non-clinical tests performed. These tests are standardized laboratory evaluations, not subjective expert assessments.

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

• This information is not applicable. The tests are objective laboratory measurements against defined numerical or categorical criteria rather than requiring adjudication of subjective expert opinions.

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 study is for a physical medical device (surgical gown), not an AI-powered diagnostic tool.

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

• No standalone algorithm performance study was done. This device is a physical product, not an algorithm.

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

• The ground truth for these tests is based on established industry standards and test methodologies (e.g., ISO 10993-5, AATCC 127, ASTM D5034, AAMI/ANSI PB70:2012). The "ground truth" is defined by the acceptance criteria set forth in these standards (e.g., hydrostatic pressure >20 cm, flammability Class 1).

8. The sample size for the training set:

• Not applicable. This device is a physical product, not a machine learning model, therefore, there is no "training set."

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

• Not applicable. As there is no training set, there is no ground truth established for it.

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