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Powder Free Yellow Synthetic Vinyl Patient Examination Gloves is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Powder Free Yellow Synthetic Vinyl Patient Examination Gloves 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.
How the device functions: a4.1 PVC films form a barrier to body fluids and bloodborne Pathogens
Scientific concepts that form the basis for the device a4.2 The PVC rubber is water tight under normal conditions of use. It's tensile properties cause it to conform to the hand, allowing movements necessary for a medical procedure.
Physical and performance characteristics such as design, materials and physical properties: a4.3 Poly (vinyl chloride) glove is known to create a barrier to bloodborne pathogens and body fluids. ASTM conforming tensile properties create a glove that is strong and flexible. The glove is manufactured in accordance with the requirements of ASTM D5250 and ASTM D5151 requirements.

The provided text describes the acceptance criteria and a study to demonstrate substantial equivalence for "Powder Free Yellow Synthetic Vinyl Patient Examination Gloves." This is a Class I medical device, and the evaluation is based on non-clinical performance testing against recognized standards.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

• ASTM D5250-06 (Reapproved 2011)
• ASTM D 5151-06 (Reapproved 2011) | Meets ASTM D5151 (Reapproved 2011)
  Holes: Inspection Level I, AQL 2.5 | Substantially equivalent |
  | Residual Powder | ASTM D 6124-06 (Reapproved 2011) | Results generated values below 2mg of residual powder | Substantially equivalent |
  | Materials Used | PVC (Predicate device) | PVC | Substantially equivalent |
  | Dusting or Donning Powder | PU (Predicate device) | PU | Substantially equivalent |
  | Dusting or Donning Powder Name | PU (Predicate device) | Surface Coating Agent | Substantially equivalent |
  | Biocompatibility | SKIN IRRITATION, DERMAL and SENSITIZATION STUDIES Meets ISO 10993-10 | The test article was not an irritant and not a sensitizer.
  SKIN IRRITATION, DERMAL and SENSITIZATION STUDIES Meets ISO 10993-10 | Substantially equivalent |

2. Sample size used for the test set and the data provenance

The document does not specify the exact sample sizes used for each individual test (e.g., length, width, thickness, pinholes, etc.). However, it indicates adherence to ASTM standards (D5250-06, D5151-06, D6124-06) and 21 CFR 800.20, which would dictate the appropriate sampling plans and statistical methods for these types of tests.

The data provenance is not explicitly stated in terms of country of origin of the data. However, the manufacturer is Made Plastic Co., Ltd. in Shijiazhuang, China, implying the testing was likely conducted in or overseen by this entity. The study is retrospective in the sense that it's a pre-market notification relying on collected test data to demonstrate substantial equivalence to an existing predicate device and established standards.

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

This type of information (number and qualifications of experts) is not applicable for this device and study. The "ground truth" for patient examination gloves is established by objective engineering and material science tests against recognized industry standards (ASTM) and regulatory requirements (21 CFR). There is no "expert consensus" or human interpretation involved in assessing, for example, the tensile strength or pinhole presence in gloves.

4. Adjudication method for the test set

Not Applicable. As explained above, the "ground truth" is determined by objective physical and chemical testing against pre-defined specifications in recognized standards. There isn't a subjective assessment that would require an adjudication method.

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-powered device. It is a physical medical device (patient examination gloves). MRMC studies are relevant for AI/radiology systems where human interpretation is a key component.

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

Not Applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used

The ground truth used for these tests is based on objective measurements against established engineering and performance standards. Specifically:

• ASTM D5250-06 (Reaffirmed 2011): Standard Specification for Vinyl Patient Examination Gloves.
• ASTM D5151-06 (Reaffirmed 2011): Standard Test Method for Detection of Holes in Medical Gloves.
• ASTM D6124-06 (Reaffirmed 2011): Standard Test Method for Residual Powder on Medical Gloves.
• ISO 10993-10: 2002/Amd. 1:2006(E): Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization (for biocompatibility).
• 21 CFR 800.20: General requirements for examination of devices (relevant for freedom from pinholes).

8. The sample size for the training set

Not Applicable. This is a physical medical device, not a machine learning model, so there is no "training set."

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

Not Applicable. As there is no training set for a machine learning model, there is no ground truth for it. The "ground truth" for the device's performance is established by the specified ASTM and ISO standards for physical and biological properties.

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Powder Free Yellow Synthetic Vinyl Patient Examination Gloves 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.

Powder Free Yellow Synthetic Vinyl Patient Examination Gloves that meets all of the requirements of ASTM standard D 5250-06(Reaffirmation 2011).

Please find the acceptance criteria and study details based on the provided text. Due to the nature of the device (patient examination gloves), the "study" is a series of performance tests against established standards, rather than a clinical study involving human readers or AI.

Device: Powder Free Yellow Synthetic Vinyl Patient Examination Gloves (K131341)

1. Table of Acceptance Criteria and Reported Device Performance

The device's performance is gauged against established ASTM standards for patient examination gloves, primarily ASTM D5250-06 (Reaffirmation 2011), ASTM D5151-06 (Reaffirmation 2011), and ASTM D6124-06 (Reaffirmation 2011). The acceptance criteria are the minimum requirements specified by these standards.

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

The document does not explicitly state the specific sample sizes used for each physical and performance test (e.g., number of gloves tested for tensile strength, pinholes, etc.). However, it indicates that the tests were conducted in accordance with ASTM standards. These standards typically specify the sampling plans and test methods.

Data Provenance: The tests are implied to be conducted by the manufacturer, Shijiazhuang Winful Plastic Co., Ltd. The data is retrospective, as it pertains to measurements taken on the manufactured gloves to demonstrate compliance with standards for the 510(k) submission. The company's address is listed as: No.6 Cangshi Road, Jinzhou City, Hebei, 052260, China. Therefore, the data originates from China.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This section is not applicable as the device is a medical glove, not an AI/imaging device requiring expert interpretation for ground truth establishment. The "ground truth" for the performance characteristics of the gloves is established by the specified ASTM standards and the validated methodologies for performing the tests detailed within those standards.

4. Adjudication Method for the Test Set

This is not applicable. The "adjudication method" concept is relevant for studies involving subjective human interpretation or AI outputs, where multiple experts might disagree on a "ground truth" label. For this device, the tests involve objective measurements against quantitative physical and chemical specifications from established standards.

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

This is not applicable. An MRMC study is designed to evaluate the diagnostic performance of a system (often AI-assisted) compared to human readers. This device is a physical product (medical glove) and does not involve diagnostic interpretation or human readers.

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

This is not applicable. This concept applies to AI algorithms. The device is a physical product.

7. The Type of Ground Truth Used

The ground truth used for proving the device meets acceptance criteria is compliance with established national and international consensus standards:

• ASTM D5250-06 (Reaffirmation 2011) - Standard Specification for Poly(vinyl chloride) Patient Examination Gloves
• ASTM D5151-06 (Reaffirmation 2011) - Standard Test Method for Detection of Holes in Medical Gloves
• ASTM D6124-06 (Reaffirmation 2011) - Standard Test Method for Residual Powder on Medical Gloves
• 21 CFR 800.20 - General provisions regarding medical devices. (specifically for waterleak test on pinhole AQL)
• ISO 10993-10: 2002/Amd. 1:2006(E) - Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization (for biocompatibility).

These standards define the acceptable physical properties, performance, and safety requirements for patient examination gloves.

8. The Sample Size for the Training Set

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

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

This is not applicable. As there is no training set for a physical product, there is no corresponding ground truth establishment process. The "ground truth" for the product's design and manufacturing quality is derived from its adherence to the aforementioned ASTM and ISO standards.

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Powder Free Yellow Synthetic Vinyl Patient Examination Gloves is a disposable device intended for medical purposes that is worn on the examiner's hand or linger to prevent comamination between patient and examiner.

Powder Free Yellow Synthetic Vinyl Patient Examination Gloves that meets all of the requirements of ASTM standard D 5250-06(Reaffirmation 2011).

Here's an analysis of the provided text regarding the acceptance criteria and study for the "Powder Free Yellow Synthetic Vinyl Patient Examination Gloves":

1. Table of Acceptance Criteria and Reported Device Performance:

Note: The document explicitly states that the "Powder Free Yellow Synthetic Vinyl Patient Examination Gloves meets all of the requirements of ASTM standard D 5250-06 (Reaffirmation 2011)" and other relevant standards. The table re-iterates specific performance metrics where provided.

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

• The document does not explicitly state the sample sizes used for the testing of the subject's device for each of the listed criteria (e.g., how many gloves were tested for length, width, tensile strength, pinholes, etc.).
• The data provenance is not specified (e.g., country of origin of data). Given the manufacturer is from China, it's likely the testing was conducted there or by a lab associated with the manufacturer.
• The data is retrospective, as it refers to tests conducted on manufactured products to demonstrate compliance with existing standards.

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 to this type of device and study. The "ground truth" for patient examination gloves is established by adherence to engineering and material performance standards (e.g., ASTM, ISO), not by expert consensus on interpretations of medical images or conditions. The standards themselves define the acceptable performance parameters.

4. Adjudication method for the test set:

• This information is not applicable for this type of device. Adjudication methods like 2+1 or 3+1 are typically used in studies involving human interpretation (e.g., radiology studies) to resolve disagreements among experts. Here, the assessment is based on objective measurements against predefined 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:

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic or interpretive devices, often involving AI, where human readers interact with the device's output. The device in question is a patient examination glove, which does not involve human readers in the context of interpretation or diagnosis that would necessitate an MRMC study.

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

• No, a standalone performance study in the context of an "algorithm only" or "AI without human-in-the-loop" was not done. This device is not an algorithm or AI system. Its performance is assessed through physical and chemical testing against established standards.

7. The type of ground truth used:

• The ground truth used is based on established industry standards and regulatory requirements. Specifically:
  • ASTM Standard D 5250-06 (Reaffirmation 2011): Standard Specification for Poly(Vinyl Chloride) Patient Examination Gloves. This defines physical characteristics like dimensions, tensile strength, elongation, and freedom from holes.
  • ASTM D 5151-06 (Reaffirmation 2011): Standard Test Method for Detection of Holes in Medical Gloves. This specifies the water leak test for pinholes.
  • ASTM D 6124-06 (Reaffirmation 2011): Standard Test Method for Residual Powder on Medical Gloves.
  • 21 CFR 800.20: FDA regulation concerning medical gloves.
  • ISO 10993-10: 2002/Amd. 1:2006(E): Biocompatibility testing for irritation and sensitization.

8. The sample size for the training set:

• This information is not applicable. There is no "training set" in the context of a medical device like a patient examination glove. Training sets are used in machine learning or AI algorithm development. The gloves are manufactured and then tested to ensure they meet specifications.

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

• This information is not applicable as there is no training set for this type of device.

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