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The Disposable Surgical Face Masks are intended to be worn to protect both the patient and healthcare personnel from transferring 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(s), provided non-sterile.

The subject Disposable Surgical Face Masks have two model: FM-34EE, Level 2 and Model: FM-44EE, Level 3.

The Disposable Surgical Face Masks (Model: FM-34EE, Level 2) are three-layer, flat-pleaded masks with nose piece and ear loops, which are composed of inner layer and outer layer. The colorant is polypropylene (PP) master batch.

The inner layer and outer layer of FM-34EE mask are made of spun-bond polypropylene, the middle layer is made of melt-blown polypropylene.

The Disposable Surgical Face Masks (Model: FM-44EE, Level 3) are four-layer, flat-pleaded masks with nose piece and ear loops, which are composed of inner layer, filtration layer and outer layer. The colorant is polypropylene (PP) master batch.

The inner layer and outer layer of FM-44EE are made of spun-bonded polypropylene, the second layer is made of PE film, the filtration layer is made of melt-blown polypropylene.

The ear loops of both models are held in place over the users' mouth and nose by two ear loops welded to the face mask. The ear loops are made with nylon and spandex. The nose piece in the layers of face mask is to allow the user to fit the mask around their nose, which is made of aluminum.

The Disposable Surgical Face Masks of both models are sold non-sterile and are intended to be single use, disposable devices.

The masks are designed and manufactured in accordance with ASTM F2100-19 Standard Specification for Performance of Materials Used in Medical Face Masks.

The acceptance criteria and study proving the device meets them are detailed below, based on the provided text.

The device in question is the "Disposable Surgical Face Masks (FM-34EE, FM-44EE)".

1. Table of Acceptance Criteria and Reported Device Performance

The device includes two models: FM-34EE (Level 2) and FM-44EE (Level 3). The acceptance criteria and performance are outlined for both levels where applicable.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the specific sample sizes for each test set (e.g., number of masks tested for BFE, differential pressure, etc.). It only indicates that "The Disposable Surgical Face Mask was tested in accordance with the tests recommended in the FDA guidance document...".

The data provenance is not specified regarding country of origin or whether it was retrospective or prospective. It is implied that the testing was conducted by the manufacturer or a contracted testing facility to support the 510(k) submission.

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

This information is not applicable. The device is a surgical face mask, and "ground truth" as typically used in AI/image analysis studies (e.g., expert consensus on medical images) is not relevant here. The performance evaluation relies on standardized laboratory test methods for physical and biological properties.

4. Adjudication Method for the Test Set

Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies involving human interpretation or subjective assessments. For the laboratory-based performance testing of the surgical face mask, no such adjudication method is mentioned or expected. The tests follow established scientific protocols with measurable outcomes.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. Surgical masks are evaluated based on their physical and biological barrier properties, not on human reader performance. Therefore, an effect size of human readers improving with AI vs. without AI assistance is not applicable to this device.

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

No, this pertains to an AI/algorithm-based device, which this surgical face mask is not. The performance is the inherent protective capability of the physical mask itself, evaluated through laboratory testing.

7. The Type of Ground Truth Used

The "ground truth" for the device's performance is established by objective, standardized laboratory test methods outlined by organizations like ASTM and ISO, and FDA guidance. These methods provide quantifiable measurements of bacterial filtration efficiency, particulate filtration efficiency, differential pressure, fluid resistance, flammability, and biocompatibility. There is no expert consensus, pathology, or outcomes data used as ground truth in the context of device performance assessment for this type of product.

8. The Sample Size for the Training Set

This information is not applicable. The device is a physical product (surgical face mask), not an algorithm or AI 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 a physical device like a surgical face mask.

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The Powder-Free Latex Examination Glove with Aloe Vera, natural water soluble Vitamin E and C and with Protein Labeling Claim (50 microgram or less per gram of glove) is a disposable device made of natural rubber latex that may bear a trace amount of glove powder and is intended for medical purpose that is worn on the examiner's hand or finger(s) to provide a barrier against potentially infectious materials and other contaminants. This device is not intended to be used as a chemical barrier.

Class I powder free latex examination gloves with Aloe Vera, natural water soluble Vitamin E and C and protein labeling claim(50 microgram or less), 80LYY, nonsterile meets all the requirements of ASTM standard D3578-01 and FDA 21 CFR 800.20.

Acceptance Criteria and Device Performance Study for Powder Free Latex Examination Gloves

This report details the acceptance criteria and the study that proves the performance of the "Powder Free Latex Examination Glove with Aloe Vera, Natural Water Soluble Vitamin E and C, and Protein Content Labeling (50 Microgram or Less)" by Qingdao Bestex Rubber & Plastic Products Co., Ltd. (K042645).

1. Acceptance Criteria and Reported Device Performance

The device's performance was evaluated against established ASTM standards and FDA regulations. The following table summarizes the acceptance criteria and the reported performance of the device:

2. Sample Size and Data Provenance

• Test Set Sample Size:

  • Physical Specifications and Dimensions: Inspection level S-2, AQL 4.0. The exact number of gloves tested is not explicitly stated, but "Inspection level S-2" refers to a specific sampling plan within ASTM/ISO standards, which dictates the sample size based on the lot size.
  • Pinholes: AQL 1.5. Similar to the above, the exact number is not explicitly stated, but AQL 1.5 implies a specific sampling plan.
  • Powder Free Tests (ASTM D 6124-01) and Protein Level (ASTM D5712-99): The specific sample sizes for these tests are not explicitly mentioned in the provided text.
  • Biocompatibility (Primary Skin Irritation and Dermal Sensitization): Not specified in the provided text, but typically involves a documented number of animal subjects (e.g., rabbits for primary skin irritation).

• Data Provenance: The studies were conducted by Qingdao Bestex Rubber & Plastic Products Co., Ltd., which is located in China. The data would therefore be considered retrospective as it was collected and analyzed as part of the submission process, and likely performed in laboratory settings.

3. Number of Experts and Qualifications for Ground Truth

• Number of Experts: Not applicable. The ground truth for this device's performance is based on objective measurements and established standards, not expert interpretation of qualitative data.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

Not applicable. The tests performed are objective, measurable tests against established standards (e.g., physical dimensions, tensile strength, pinhole count, chemical assays for powder and protein, animal biocompatibility studies). There is no "adjudication" in the sense of multiple human reviewers reaching a consensus on a subjective outcome.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This device is a medical glove, and its effectiveness is determined by its physical and chemical properties as a barrier, not by human interpretation or diagnostic accuracy in comparison to AI assistance.

6. Standalone Performance Study

Yes, a standalone study was performed. The device's performance was evaluated independently against the specified ASTM standards and FDA regulations without human-in-the-loop performance being a factor. This means the algorithm (or the glove's inherent design and manufacturing) was directly tested against objective criteria.

7. Type of Ground Truth Used

The ground truth used for these studies is based on:

• Established Standards: ASTM D 3578-01, ASTM D 6124-01, ASTM D5712-99, and FDA 21 CFR 800.20. These standards define the acceptable range or threshold for specific physical, chemical, and biological properties.
• Objective Measurements: Laboratory tests and measurements were conducted to quantify the device's characteristics against these standards (e.g., measuring dimensions, counting pinholes, chemical analysis for powder and protein, observing animal reactions for biocompatibility).

8. Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI/machine learning algorithm that requires a "training set" in the computational sense. The manufacturing process is refined through quality assurance, but there isn't a "training set" like in software development.

9. How Ground Truth for the Training Set Was Established

Not applicable, as there is no "training set" in the context of this physical medical device. The "ground truth" for manufacturing quality and process control would be established through adherence to Good Manufacturing Practices (GMP) and ongoing quality control checks, ensuring that each batch meets the established specifications based on the ASTM and FDA standards.

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The Powder Free Nitrile Examination Glove (blue) with natural water soluble Vitamin E and Aloe Vera, Peppermint scented is a disposable device intended for medical purpose that is worn on the examiner's hand or finger(s)to prevent contamination between patient and examiner.

Class I powder free nitrile examination gloves (blue) with natural water soluble Vitamin E and Aloe vera, peppermint scented, 80LZA, non-sterile meets all the requirements of ASTM standard D6319-00ae3 and FDA 21 CFR 800.20.

Here's an analysis of the provided text regarding the acceptance criteria and study for the "Powder Free Nitrile Examination Gloves (Blue) with Natural Water Soluble Vitamin E and Aloe Vera, Peppermint Scented."

It's important to note that this device is a Class I medical device (patient examination glove), which typically undergoes different and less stringent testing than more complex AI-powered diagnostic devices. Therefore, many of the requested categories (like MRMC studies, expert consensus on ground truth, or sample sizes for test/training sets in the context of an AI algorithm) are not applicable here.

Acceptance Criteria and Device Performance

Study Details

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

   • The document states that testing for physical specifications and dimensions was "conducted on gloves, Inspection level S-2, AQL 4.0, Pinholes at AQL 1.5." This refers to sampling plans defined in standards like ASTM D6319-00ae3 which specifies acceptable quality limits (AQL) and inspection levels (e.g., S-2 for reduced inspection). The exact number of samples tested for each criteria is not explicitly stated in the summary, but these AQL and inspection levels dictate the sample size.
   • Data Provenance: Not explicitly stated, but assumed to be from the manufacturer's internal testing. Likely retrospective data from manufacturing lots. No country of origin for the data is specified other than the manufacturer being in China.

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

   • Not applicable. This device is a glove, and ground truth for its performance properties (dimensions, physical properties, pinholes, powder residue) is established through standardized laboratory testing methods, not expert human assessment. Biocompatibility tests on rabbits are also standard laboratory procedures rather than expert consensus on human data.

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

   • Not applicable. Performance is measured against objective standards, not through human adjudication of subjective assessments.

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:

   • Not applicable. This is a physical medical device (glove), not an AI-powered diagnostic or assistive technology.

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

   • Not applicable. This is a physical medical device.

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

   • For Dimensions, Physical Properties, Freedom from Pinholes, Powder Residue: Ground truth is defined by the objective, measurable parameters and thresholds specified in the referenced ASTM standards (e.g., specific tensile strength, elongation, maximum acceptable force at break, number of pinholes per batch, maximum powder residue) and FDA regulations.
   • For Biocompatibility: Ground truth is established by the results of standardized animal tests (Primary Skin Irritation in Rabbits, Dermal Sensitization) compared against established pass/fail criteria for these tests.

7. The sample size for the training set:

   • Not applicable. This is a physical medical device and does not involve AI/machine learning training sets.

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

   • Not applicable. This is a physical medical device.

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The Powder-Free Latex Examination Glove (green) with natural water soluble Vitamin E and Protein Labeling Claim(50 microgram or less per gram of glove) is a disposable device made of natural rubber latex that may bear a trace amount of glove powder and is intended for medical purpose that is worn on the examiner's hand or finger(s)to provide a barrier against potentially infectious materials and other contaminants. This device is not intended to be used as a chemical barrier.

Class I powder free latex examination gloves (green) with natural water soluble Vitamin E and protein labeling claim(50 microgram or less), 80L Y Y, non-sterile meets all the requirements of ASTM standard D3578-01 and FDA 21 CFR 800.20.

This document describes the acceptance criteria and study proving the device meets those criteria, based on the provided 510(k) summary for "POWDER FREE LATEX EXAMINATIN GLOVES (GREEN) WITH NATURAL WATER SOLUBLE VITAMIN E AND PROTEIN LABELING CLAIM (50 MICROGRAM OR LESS PER GRAM OF GLOVE)".

It's important to note that this is a medical device submission for examination gloves, not an AI/Software as a Medical Device (SaMD) submission. Therefore, many of the typical questions related to AI studies (like MRMC, training set details, expert qualifications for AI ground truth) are not applicable to this type of device. The focus here is on physical and chemical performance standards.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Physical/Dimensional Testing: The document states that testing meets requirements for physical specifications and dimensions "conducted on gloves, Inspection level S-2, AQL 4.0, Pinholes at AQL 1.5". This indicates a sampling plan was used according to specific ASTM/FDA guidelines, but the exact number of gloves tested is not explicitly stated as a single number.
• Data Provenance: The device is manufactured by Qingdao Bestex Rubber & Plastic Products Co. Ltd. in Qingdao, China. The testing would have been conducted by or for this manufacturer. The nature of these tests (material properties, biocompatibility) implies they are prospective tests performed on samples of the manufactured device.

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

• Not Applicable. For examination gloves, "ground truth" is established by adherence to predefined, objective physical, chemical, and biological performance standards (e.g., tensile strength, protein content by specific assay, irritation in animal models). There are no human "experts" establishing a subjective ground truth in the way done for image interpretation in AI studies. The tests are performed according to established protocols by laboratory personnel.

4. Adjudication Method for the Test Set

• Not Applicable. As mentioned above, "adjudication" in the context of expert consensus for subjective interpretations does not apply to this device. The results are objective measurements against established criteria.

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

• No. An MRMC study is not relevant for this type of medical device. These studies are typically used to assess the impact of AI on human reader performance in diagnostic tasks.

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

• Not Applicable. This is a physical product (gloves), not an algorithm or software. Therefore, there is no "standalone algorithm performance" to assess.

7. The type of ground truth used

• Objective Standards and Laboratory Test Results. The "ground truth" for this device is based on:
  • Defined Standards: ASTM (American Society for Testing and Materials) standards (D 3578-01, D 6124-97, D5712-95) and FDA regulations (21 CFR 800.20).
  • Laboratory Measurements: Quantitative measurements (e.g., protein content, powder content) and qualitative assessments (e.g., presence of pinholes, pass/fail for biocompatibility tests) performed according to these standards.
  • Animal Models: Biocompatibility was assessed using "Primary Skin Irritation In Rabbits" and "Dermal Sensitization" tests, which are standard biological tests in animal models.

8. The sample size for the training set

• Not Applicable. There is no "training set" in the context of this device. This is a manufactured product, not a machine learning model.

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

• Not Applicable. As there is no training set, this question is not relevant.

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A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner. (21CFR 880.6250)

Class I powder free colored(green) latex examination gloves with aloe vera and protein labeling claim(50 microgram or less) ,80LYY, non-sterile meets all the requirements of ASTM standard D3578-00 and FDA 21 CFR 800.20.

This is an examination glove, not an AI/ML device. Hence, the requested information about AI/ML device studies and ground truth is not applicable.

However, I can provide the acceptance criteria and performance of the glove:

Acceptance Criteria and Device Performance

Study Information (Not Applicable for AI/ML Device)

Since this is not an AI/ML device, the following points are not applicable:

2. Sample size used for the test set and the data provenance: Not applicable. Performance testing was done on batches of gloves according to ASTM and FDA standards (e.g., Inspection level S-2, AQL 4.0 for dimensions and physical properties, AQL 1.5 for pinholes).
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 glove performance is defined by established industry and regulatory standards.
4. Adjudication method: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used: Ground truth is based on physical and chemical testing against established standards (ASTM and FDA regulations).
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

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