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A powder free patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hands or fingers to prevent contamination between patient and examiner.

The proposed device is a powder free medical glove. The device is made from a nitrile latex compound, blue in color. The device meets the requirements of ASTM D6319-19: Standard specification for Nitrile Examination Gloves for Medical Application. The device is available in five sizes, which are XS, 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 device can be provided in non-sterile.

This document is a 510(k) Premarket Notification for "Medical Gloves" (K203622). It describes the device's characteristics, its intended use, and comparative testing against a predicate device (K180467) to demonstrate substantial equivalence.

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

Device Under Evaluation: Medical Gloves (powder-free patient examination glove, nitrile latex compound, blue color)

1. Table of Acceptance Criteria and Reported Device Performance

Study that Proves the Device Meets the Acceptance Criteria (Non-Clinical Testing):

The document explicitly states: "Non clinical tests were conducted to provide data that the proposed devices met the acceptance criteria or the specification for the test methodology or standard shown below. The test results demonstrated that the proposed devices comply with the following standards."

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

• Sample Size: The document does not explicitly state the specific number of gloves or animals used for each test. However, it references specific ASTM and ISO standards (e.g., ASTM D5151-19, which specifies AQL levels and inspection levels for Freedom from Holes). These standards define appropriate sample sizes for testing compliance. For instance, ASTM D5151-19, AQL 2.5, Inspection Level G-1 means the sample size is determined by the lot size, but for the specifically mentioned acceptance/rejection criteria (Accept at 5 failures, Reject at 6 failures), it implies a certain sample size bracket within the standard.
• Data Provenance: The document does not specify the country of origin where the non-clinical tests were performed. It states the sponsor is Beijing Biosis Healing Biological Technology Co., Ltd. from China, so it's reasonable to infer the tests were conducted in or overseen by this entity. The data is retrospective in the sense that the tests were performed, and the results are being reported as part of a premarket submission.

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

• This section talks about the establishment of ground truth for a test set, typically relevant for AI/ML device evaluations. This document describes the evaluation of a physical medical device (gloves) against established performance standards. Therefore, the "ground truth" is based on objective, standardized test methods and their defined acceptance criteria. It is not based on expert consensus interpreting subjective data.
• The tests themselves are performed by trained personnel in a laboratory setting, but the document does not specify the number or qualifications of these individuals, as it's not a multi-reader study.

4. Adjudication Method for the Test Set

• Not applicable. This is not a study involving human readers or subjective interpretations requiring adjudication. The tests are objective and based on physical measurements and chemical analyses as per 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

• Not applicable. This is not an AI/ML device that assists human readers. It is a physical medical device (gloves).

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

• Not applicable. This is not an algorithm or AI device. The "standalone" performance refers to the device's ability to meet the specified performance criteria as tested in isolation according to the listed ASTM and ISO standards. The results table clearly indicates that the device met these criteria.

7. The Type of Ground Truth Used

• The ground truth used for this device's evaluation is primarily objective, standardized test results based on established international (ISO) and national (ASTM) consensus standards. These standards define measurable physical, chemical, and biological properties, along with clear acceptance/rejection criteria. For biocompatibility tests (skin sensitization, irritation, acute toxicity), the ground truth is established by the biological responses observed in the test models (e.g., animal models) according to the protocols defined in ISO 10993.

8. The Sample Size for the Training Set

• Not applicable. This is not an AI/ML device that requires a "training set." The device itself is a manufactured product, not a learned algorithm.

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

• Not applicable, as there is no training set for this type of device.

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A powder-free, non-sterile patient examination glove is a disposable device intended for medical purposes to be worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Patient Examination glove - Disposable- Single use only - Non-sterile - The C2 Powder Free Polyethylene Examination Gloves are made of translucent (clear), . Low Density Polyethylene material and are powder free. The C2 Powder Free Polyethylene Examination Gloves come in five sizes: Small, Medium, Large, X Large and XX Large. The gloves are loose fitting.

The provided document describes the acceptance criteria and the study that proves the AmerCare C2 Powder Free Polyethylene Examination Glove meets those criteria.

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 (e.g., tensile strength, pinholes). It refers to compliance with recognized standards (ASTM D 5250-06 for physical properties, ASTM D 6124-06 for powder-free, US 21CFR 800.20 for water leakage, and ISO 10993-1, 10993-5, 10993-10 for biocompatibility). These standards typically define the sampling plans and testing methodologies. The provenance of the data is not specified beyond being "non-clinical testing" conducted by AmerCare Inc.

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 device is an examination glove, and its performance is evaluated against material and physical property standards, not through expert-driven ground truth establishment of medical images or conditions.

4. Adjudication method for the test set:

   This information is not applicable for this type of device and testing. Performance is measured against objective, standardized physical and chemical properties.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

   No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic or assistive devices where human interpretation is involved. For an examination glove, the "effectiveness" is determined by its physical and material properties meeting established standards, not by human reader performance.

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

   This is not applicable. The device is a physical product (an examination glove), not an algorithm or a software device. The standalone performance refers to the device's physical and chemical attributes, which were tested.

7. The type of ground truth used:

   The "ground truth" for the performance evaluation of the C2 Powder Free Polyethylene Examination Glove is based on recognized consensus standards for patient examination gloves. Specifically:

   • ASTM D 5250-06: Standard Specification for Poly (vinyl chloride) Gloves for Medical Application (applied to polyethylene gloves for substantial equivalence).
   • ASTM D 6124-06: Standard Test Method for Residual Powder on Medical Gloves.
   • US 21 CFR 800.20: Water Leakage Test.
   • ISO 10993-1, 10993-5, 10993-10: Biological evaluation of medical devices (for biocompatibility).

8. The sample size for the training set:

   This information is not applicable. The device is a physical product, not an AI/ML algorithm that requires a training set.

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

   This information is not applicable. There is no training set for this type of medical device.

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A patient examination glove is a disposable device intended for medical purpose and similiar personnel to prevent contamination between health care personnel and the patient.

Latex examination gloves (with a protein label claim), Peccaler of Contamp 170 mili grams on less

This document is a 510(k) clearance letter from the FDA for "Quality Latex Powdered Examination Gloves with Protein Labeling Claim of 170 micrograms or less." It does not contain information about acceptance criteria or a study proving that a device meets acceptance criteria. Instead, it is specifically about the regulatory approval of a medical glove.

Therefore, I cannot provide the requested information.

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