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A patient examination glove is disposable non-sterile device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Powder Free Vinyl Patient Examination Gloves (Yellow, White, Blue, Pink) are Patient Examination Gloves, Disposable, single use only and non-sterile. The gloves are made of vinyl materials and are powder free. The physical and performance characteristics of the devices meet all requirements of ASTM D5250-06 (Reapproved 2011) Standard Specification For Poly(Vinyl Chloride) Gloves For Medical Application.

The provided document is a 510(k) summary for "Powder Free Vinyl Patient Examination Gloves (Yellow, White, Blue, Pink)" by Ever Light Plastic Products Company, Ltd. It details the safety and effectiveness information for the device.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the device are largely based on the ASTM D5250-06 (Reapproved 2011) Standard Specification For Poly(Vinyl Chloride) Gloves For Medical Application and ISO 10993-10 for biocompatibility.

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

The document does not explicitly state the total sample size for the "test set" in a sense that would be typically used for a machine learning model. Instead, it refers to specific sample sizes for particular physical tests:

• Pinhole Test: 125 gloves sampled (for both subject and predicate device performance comparison, and also for the actual testing results).
• Residual Powder: N=5 gloves.
• Other Physical Property Tests (Tensile Strength, Elongation, Dimensions): The inspection level for these tests is S-2, AQL 4.0. While this specifies the sampling plan, the exact number of units sampled for each lot/test is not explicitly given as a single number but is determined by the AQL (Acceptance Quality Limit) table itself.

Data Provenance: The document explicitly states the manufacturer's location as Donggao Industrial Zone Zanhuang, Shijiazhuang, Hebei, China 050000. This indicates the country of origin of the data is China. The studies described are non-clinical (laboratory testing of physical and chemical properties) and appear to be prospective, performed specifically for this 510(k) submission.

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 submission. This is a medical device for which physical characteristics and biocompatibility are tested against established standards (ASTM, ISO). There are no "experts" establishing a "ground truth" in the way one would for diagnostic imaging or a qualitative assessment. The "ground truth" is the objective measurement of the device's properties against predefined quantitative and qualitative standards.

4. Adjudication Method for the Test Set

This information is not applicable. Since the evaluation is against objective, standardized measurements and criteria (e.g., MPa for tensile strength, % for elongation, AQL for pinholes), there's no need for an adjudication method by experts to resolve disagreements. The results are quantitative measurements or qualitative assessments against a defined standard (e.g., "not an irritant").

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 an examination glove, not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies and AI assistance are irrelevant to its evaluation.

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

This information is not applicable. The device is an examination glove, not an algorithm or software. Therefore, standalone algorithm performance is irrelevant.

7. The Type of Ground Truth Used

The ground truth used for this device is based on established consensus standards and objective measurements:

• ASTM D5250-06 (Reapproved 2011) for physical properties (tensile strength, elongation, pinholes, dimensions, residual powder).
• ISO 10993-10 for biocompatibility (primary skin irritation and dermal sensitization).

These standards represent a regulatory and scientific consensus on acceptable performance for medical examination gloves.

8. The Sample Size for the Training Set

This information is not applicable. This is not an AI/ML device that requires a "training set." The device performance is assessed through direct physical and biocompatibility testing against predefined standards.

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

This information is not applicable for the same reason as above. There is no training set for this type of medical device.

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A patient examination glove is disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Classified by FDA's General Hospital and Personal Use Device panel as Class I, 21 CFR 880.6250, Power Free Vinyl Patient Examination Glove, 80 LYZ, and meets all requirements of ASTM standard D5250-06e1.

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Hongze Plastic Technology Co., Ltd. Powder Free Vinyl Patient Examination Gloves:

Acceptance Criteria and Device Performance

Study Information

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

   • Physical and Dimensions Testing: Inspection level S-2, AQL 4.0. (No specific number of gloves given for the test set, but AQL and inspection level define the sampling plan.)
   • FDA 1000 ml Water Fill Test (Pinhole): AQL 2.5, inspection level 1. (No specific number of gloves given for the test set, but AQL and inspection level define the sampling plan.)
   • Primary Skin Irritation and Skin Sensitization: Not explicitly stated, but typically involves a certain number of human subjects or animal models according to the test standards.
   • Residual Powder Test: Not explicitly stated.
   • Data Provenance: Not specified, but generally refers to in-house laboratory testing by the manufacturer or a contracted lab. The document implies the tests were conducted by or for Hongze Plastic Technology Co., Ltd.

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

   • Not applicable. These are objective physical and chemical tests, not diagnostic or subjective evaluations requiring expert consensus for ground truth.

3. Adjudication method for the test set:

   • Not applicable. The tests are based on objective pass/fail criteria from ASTM standards and FDA requirements.

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 device is a patient examination glove, not an AI-powered diagnostic or assistive tool.

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

   • Not applicable. This is not an algorithmic device.

6. The type of ground truth used:

   • Objective measurements/standards: The ground truth for these tests is established by the specified ASTM standards (D5250-06e1, D-6124-06) and FDA requirements (1000 ml Water Fill Test). These standards define acceptable ranges for physical properties, maximum defect rates (AQL), and chemical residue levels. Biocompatibility (irritation/sensitization) also has established clinical/toxicological parameters for "no reaction."

7. The sample size for the training set:

   • Not applicable. There is no machine learning or AI component that would require a training set. The "training" here refers to the manufacturing process adhering to quality control standards.

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

   • Not applicable, as no training set for AI is involved. The manufacturing process is geared towards meeting established product specifications and quality standards defined by ASTM and regulatory bodies.

Ask a specific question about this device

A patient examination glove is disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Power Free Vinyl Patient Examination Gloves, (Yellow, white, blue, pink), 80 LYZ, and meets all requirements of ASTM standard D-5250-06e1.

Here's a breakdown of the acceptance criteria and study information for the Better Care Plastic Products Co., Ltd. Powder Free Vinyl Patient Examination Gloves, based on the provided K092301 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Physical and Dimensions Testing: Inspection level S-2, AQL 4.0. The specific number of gloves tested is not explicitly stated, but it would be determined by the sampling plan outlined in ASTM-D-5250-06e1 for an AQL of 4.0 at an S-2 inspection level.
• Pinhole Detection (Water Fill Test): AQL 2.5, Inspection Level I. The specific number of gloves tested is not explicitly stated, but it would be determined by the sampling plan for an AQL of 2.5 at an Inspection Level I.
• Primary Skin Irritation and Skin Sensitization: The document states "testing was conducted" but does not specify the sample size (e.g., number of subjects or samples) used for these biocompatibility tests.
• Residual Powder Test: Based on ASTM D-6124-06. The number of gloves tested for residual powder is not explicitly stated.
• Data Provenance: The document does not specify the country of origin for the data or if the studies were retrospective or prospective. Given that this is a 510(k) for a manufacturing company, it's likely that the tests were conducted by or on behalf of the manufacturer to demonstrate compliance with standards.

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

This type of device (patient examination gloves) does not typically involve human experts establishing "ground truth" in the way an AI diagnostic device would. The "ground truth" for these tests is established by objective, standardized laboratory measurements and compliance with industry standards (e.g., ASTM standards, AQL limits for defects). There are no "experts" in the sense of clinicians interpreting results for a test set.

4. Adjudication Method for the Test Set

Not applicable. The tests performed are objective laboratory tests with defined pass/fail criteria based on standards. There is no subjective interpretation requiring adjudication among multiple readers.

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

No. An MRMC study is relevant for AI devices that assist human readers in tasks like image interpretation. This device is a physical product (gloves), and its performance is evaluated through material and quality control tests, not through human reader interpretation.

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

Yes, in a sense. The tests performed (physical, dimensions, pinhole, biocompatibility, residual powder) evaluate the intrinsic properties and performance of the glove itself, without any human-in-the-loop or interpretive component in the way an algorithm would be evaluated. The "device" (glove) is tested in a standalone manner against defined physical and chemical parameters.

7. The Type of Ground Truth Used

The ground truth used for these tests is objective, standardized measurements and compliance with established industry standards.

• For physical properties and dimensions, the ground truth is defined by the tolerances and specifications within ASTM-D-5250-06e1.
• For pinholes, the ground truth is defined by the FDA 1000 ml. Water Fill Test and its AQL 2.5 acceptance criterion.
• For biocompatibility (skin irritation and sensitization), the ground truth is established by the absence of adverse reactions in standardized biological tests.
• For residual powder, the ground truth is the quantitative measurement of powder content against the 2 mg per glove limit specified by ASTM D-6124-06.

8. The Sample Size for the Training Set

Not applicable. This device is a physical product, not an algorithm that requires a training set.

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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