Search Results

Synguard Nitrile Exam Glove 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 proposed device is a powder free medical glove. The device is blue in color. The device meets the requirements of ASTM D6319-19: Standard specification for Nitrile Examination Gloves for Medical Application. The proposed gloves are available in four sizes, which are S, M, L, XL, it could be selected by the user depended on size of hand. The different between each size is just in the dimension. The proposed device is provided in non-sterile.

The provided document describes the acceptance criteria and study results for the "Synguard Nitrile Exam Glove".

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 used for each specific test. However, it indicates that "non-clinical tests were conducted to verify that the performance of the proposed device met all design specifications of the applicable and current standards." These tests were likely conducted on samples of the Synguard Nitrile Exam Glove. The data provenance is implied to be from laboratory testing according to international standards (ASTM and ISO).

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. The tests performed are non-clinical, laboratory-based tests comparing physical and chemical properties to established industrial standards (ASTM, ISO), not involving human expert interpretation of results for ground truth.

4. Adjudication method for the test set

This information is not applicable as the tests are objective laboratory measurements against defined 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 information is not applicable. The device is a medical examination glove, which does not involve AI or human readers for diagnostic interpretation.

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 examination glove, which is a physical product and does not involve algorithms or AI performance.

7. The type of ground truth used

The "ground truth" for the performance of the Synguard Nitrile Exam Glove is based on adherence to established international industrial standards and specifications. These include:

• ASTM D6319-19: Standard Specification for Nitrile Examination Gloves for Medical Application
• ASTM D5151-19: Standard Test Method for Detection of Holes in Medical Gloves
• ASTM D3767-03 (2020): Standard Practice for Rubber-Measurement of Dimensions
• ASTM D412-16: Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers-Tension
• ASTM D6124-06 (Reapproved 2017): Standard Test Method for Residual Powder on Medical Gloves
• ISO 10993-10:2010: Biological Evaluation of Medical Devices-Part 10: Tests for Irritation and Skin Sensitization
• ISO 10993-11:2009: Biological evaluation of medical devices-Part 11: Tests for systemic toxicity

These standards define the acceptable ranges and performance criteria for the physical, chemical, and biological properties of examination gloves.

8. The sample size for the training set

This information is not applicable. As a physical medical device (examination glove), there is no 'training set' in the context of machine learning or AI models. The device's manufacturing processes and quality control procedures are engineered to meet the aforementioned standards.

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

This information is not applicable for the same reasons mentioned in point 8.

Ask a specific question about this device

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

The Medical Surgical Masks are single use, flat-pleated masks that are provided in blue. The Medical Surgical Masks are available in two types, which are Level 3 based on ASTM F2100-19. The outer and inner layers of the mask are made of spunbond polypropylene. The middle filter layer of Level 2 mask is made of one layer of meltblown polypropylene filter, and the middle filter layer of Level 3 mask is made of two layers of meltblown polypropylene filter. The nose clip is made of polyethylene (PE) and iron. Users can adjust the nose clip according to the shape of the bridge of the nose, and fix the mask on the bridge of the nose to prevent the mask from falling off.

The Level 2 masks are ear-loop masks. The Level 3 masks are available in two types, ear-loop and Tie-on. The ear loops for Level 2 and Level 3 masks are made of spandex. The ties are made of spunbond polypropylene. The ear loops/ties are held in place over the users' mouth and nose by two ear loops/ties welded to the mask.

The provided document (K210030 510(k) Summary for the Medical Surgical Mask) describes the performance and testing of a medical surgical mask, not an AI/ML powered device. Therefore, many of the questions related to AI/ML specific studies (e.g., sample size for training set, MRMC study, ground truth establishment for training, number of experts for test set ground truth) are not applicable to this submission.

However, I can extract the acceptance criteria and performance data for the medical device described.

Summary of Device Performance and Testing (Medical Surgical Mask)

The submission focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing against recognized standards. No clinical studies were included.

1. Table of Acceptance Criteria and Reported Device Performance

The device is evaluated against the requirements for ASTM F2100-19, which defines performance levels for medical face masks. The proposed device includes both Level 2 and Level 3 masks.

Ask a specific question about this device