Search Results

A patient examination glove is a disposable device intended for medical purposes that is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste or environment.
A patient examination glove is disposable device intended for medical a 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, Powdered Vinyl Patient Examination Glove, 80L YZ, and meets all requirements of ASTM Standard D5250-00E4.

This submission is for a Class I medical device, "Grand Work Plastics Products Co., Ltd. Synthetic Vinyl Patient Examination Gloves—Powdered," which is a disposable patient examination glove. As such, the acceptance criteria and supporting studies are focused on performance characteristics relevant to patient examination gloves, rather than those for complex diagnostic algorithms.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the specific sample sizes used for each test. Instead, it refers to "Inspection Level S-2, AQL 4.0" for physical and dimensions testing, and "AQL 2.5, Inspection Level I" for the water fill test. These are sampling plans from the referenced ASTM standards, which define how many units are tested from a lot to determine acceptance.

The data provenance is not specified in terms of country of origin, but the testing was performed by the manufacturer, Grand Work Plastics Products Co., Ltd., which is located in Zanhuang, Hebei Province, P.R. China. The studies are non-clinical (laboratory/bench testing), not involving human subjects.

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

This question is not applicable in the context of this device. The "ground truth" for patient examination gloves is established by the specified ASTM standards and FDA guidelines, which define measurable physical and chemical properties and their acceptable limits. Expert consensus as typically understood for diagnostic algorithms (e.g., radiologists interpreting images) is not used here.

4. Adjudication Method for the Test Set

Adjudication methods (like 2+1, 3+1) are typically used for subjective diagnostic interpretations in the context of clinical studies involving multiple human readers. This is not relevant for the objective, standardized non-clinical tests performed on patient examination gloves. The tests involve direct measurement and adherence to predefined criteria.

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 involves comparing the diagnostic performance of multiple human readers, often with and without AI assistance, on a set of cases. This is completely irrelevant for a patient examination glove.

6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done

While the term "standalone study" usually refers to the performance of an AI algorithm without human intervention, if we interpret it generally as the device's inherent performance without human human-in-the-loop interaction, then yes, the tests described (physical, dimensions, water fill, skin irritation, sensitization, residual powder) assess the standalone performance of the glove itself against established standards. There is no "algorithm" involved.

7. The Type of Ground Truth Used

The ground truth used for this device is based on established industry standards and regulatory requirements. Specifically:

• ASTM Standard D5250-00E4: Standard Specification for Poly(vinyl chloride) Patient Examination Gloves.
• ASTM Standard D5151-99: Standard Test Method for Detection of Pinholes in Medical Gloves.
• ASTM D6124-01: Standard Test Method for Residual Powder on Medical Gloves.
• Biocompatibility standards: For primary skin irritation and sensitization.
  These standards define the acceptable range or absence of certain characteristics (e.g., tensile strength, elongation, freedom from holes, absence of irritation).

8. The Sample Size for the Training Set

This question is not applicable. "Training set" refers to data used to train a machine learning algorithm. This device is a physical product, not an AI algorithm, and therefore does not have a training set.

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

This question is not applicable, as there is no training set for a physical patient examination glove.

Ask a specific question about this device

A glove is worn on the hand of healthcare personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste or environment. A patient examination 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.

Classified by FDA's General and Plastic Surgery Device Panel as Class I, 21 CFR 880.6250, Vinyl Patient Examination Glove, 80LYZ, Powdered with Absorbable Dusting Powder, USP, Class III and meets all requirements of ASTM Standard D5250-92.

Acceptance Criteria & Study Analysis for K974151: Vinyl Patient Examination Gloves

This device, the Shanghai Super Gloves Co., Ltd. Vinyl Patient Examination Gloves - Powdered, is a Class I medical device (21 CFR 880.6250) and is substantially equivalent to predicate devices. The safety and effectiveness are established through compliance with existing industry standards and specific tests, not through clinical trials in the traditional sense, as there are no specific claims requiring such studies (e.g., hypoallergenic).

1. Table of Acceptance Criteria and Reported Device Performance

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

• Physical and Dimensions: The document states "Inspection Level S-2, AQL 4.0". This refers to attributes sampling plans defined in standards like ISO 2859 (or MIL-STD-105E from which it is derived).
  • AQL (Acceptable Quality Level) 4.0: This means that the statistical sampling plan is designed to accept lots where the percentage of defective items is 4.0% or less.
  • Inspection Level S-2: This is a special inspection level for circumstances where smaller sample sizes are desired, usually for testing that is destructive or expensive, while still providing some protection. The exact sample size would depend on the batch size, but for S-2, it would be significantly smaller than general inspection levels.
• Barrier Integrity (Pinhole Defects): The document states "samplings of AQL 2.5, Inspection Level S-4".
  • AQL 2.5: This means the sampling plan is designed to accept lots where the percentage of defective items is 2.5% or less.
  • Inspection Level S-4: Similar to S-2, this is a special inspection level for reduced sample sizes.
• Biocompatibility: No specific sample sizes for these tests are provided in the summary. Standardized tests (e.g., ISO 10993 series which often includes these tests) would typically specify the number of animals or human subjects (for patch tests) required, but the summary only provides the results.
• Data Provenance: The device is manufactured by Shanghai Super Gloves Co., Ltd. in Shanghai, China. The testing was conducted by the manufacturer, or by a testing laboratory on behalf of the manufacturer, to demonstrate compliance with the stated standards. The document does not specify if the data is retrospective or prospective, but given it's for a 510(k) submission, it would reflect tests performed for this submission.

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

• Not Applicable in the traditional sense for this device.
• For these types of devices (examination gloves), "ground truth" is established by adherence to recognized industry standards (ASTM-D-5250-92 for physical properties, FDA 1000 ml water fill test for pinholes, and general biocompatibility testing standards). The "experts" involved are the certified testing laboratories and their personnel who conduct these standardized tests according to established protocols and interpret the results against the defined acceptance criteria.
• There would not be a panel of human experts establishing a subjective "ground truth" for each glove.

4. Adjudication Method for the Test Set

• Not Applicable. As "ground truth" is based on objective, standardized tests against specified criteria, there is no need for expert adjudication. The tests yield definitive results (e.g., pass/fail for pinholes, quantitative measurements for physical properties, presence/absence of irritation for biocompatibility) which are then compared directly to the acceptance criteria.

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

• No. This type of study is not relevant or applicable for an examination glove. MRMC studies are typically used to evaluate diagnostic imaging devices or algorithms where human readers interpret medical images.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• Not Applicable. This is not an algorithmic or AI-enabled device. Its performance is intrinsic to its physical and chemical properties.

7. Type of Ground Truth Used

• Objective Test Results against Established Standards: The ground truth for this device is based on objective measurements and observations derived from standardized tests. Examples include:
  • Physical Properties: Measurements of dimensions, tensile strength, elongation, etc., compared against the specifications in ASTM-D-5250-92.
  • Pinhole Detection: Direct observation using the FDA 1000 ml Water Fill Test.
  • Biocompatibility: Clinical observation of skin reactions in standardized animal or human patch tests, interpreted against established criteria for irritation and sensitization.
• The "ground truth" here is the direct, measurable compliance with these recognized benchmarks.

8. Sample Size for the Training Set

• Not Applicable. This device does not involve machine learning or AI, and therefore does not have a "training set" in the computational sense. The manufacturing process is designed to consistently produce gloves that meet the specifications, and quality control sampling is an ongoing process, not a "training set."

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

• Not Applicable. No training set exists for this device.

Ask a specific question about this device

A patient examination 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.

Classified by FDA 's General and Plastic Surgery Device Panel as Class I, 21CFR 880.6250. Vinyl Patient Examination Glove, 80LYZ, Powdered with an absorbable dusting starch powder, USP, Class III. conform to all requirements of ASTM Standard D5250-92 and FDA 1000ml water leak test.

This is a 510(k) summary for Vinyl Patient Examination Gloves, Powdered. It describes the device, its intended use, and compares its performance to the ASTM D5250-92 standard and the FDA 1000ml water leak test.

Here's a breakdown of the requested information:

1. Table of acceptance criteria and the reported device performance

Study Proving Device Meets Acceptance Criteria:

The document states that the "Applicant devices comply with ASTM Standard D-5250-92 and FDA 1000ml water leak test for pin-holes." It also mentions a "Modified Draize Test" for clinical performance.

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

• Non-Clinical Performance Data (Physical Properties and Water Leak Test): The document does not specify the exact sample sizes used for each of the physical property tests (length, width, thickness, tensile strength, elongation). For the FDA Water Leak Test, it mentions an "Inspection Level of S-4," which is a sampling plan specification, but not the absolute number of gloves tested.
• Clinical Performance Data (Modified Draize Test): The document refers to "human subjects" but does not specify the number of subjects used in the Modified Draize Test.
• Data Provenance: The document is from Everrise Glove Products Co., Ltd. in Tainan Hsien, Taiwan, R.O.C. The data appears to be prospective testing conducted by the manufacturer to demonstrate compliance with 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 provided in the document. The tests performed are objective measurements against defined standards (ASTM D5250-92 and FDA 1000ml water leak test) and a standardized skin irritation test (Modified Draize Test). These do not typically involve human expert "ground truth" establishment in the way medical imaging or diagnostic algorithms do.

4. Adjudication method for the test set

This is not applicable as the tests performed are objective measurements against established 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 is not applicable as the device is a vinyl patient examination glove, not an AI-assisted diagnostic or imaging system.

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

This is not applicable as the device is a physical product (gloves), not an algorithm.

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

The "ground truth" for the non-clinical performance data is defined by the ASTM Standard D5250-92 specifications and the FDA 1000ml water leak test criteria. For the clinical performance, the "ground truth" is the lack of clinically significant irritation or allergic contact dermatitis as determined by the Modified Draize Test. This is based on direct observation of human physiological reactions rather than expert consensus on subjective data or pathology.

8. The sample size for the training set

This is not applicable. The context is a medical device (gloves) undergoing testing against established standards, not a machine learning model that requires a training set.

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

This is not applicable for the reasons stated in point 8.

Ask a specific question about this device