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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 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, Powdered vinyl Patient Examination Glove, 80LYZ, Powdered with Absorbable Dusting Powder, USP, and meets all requirements of ASTM Standard D5250-00-4.

The provided text describes a submission for a 510(k) premarket notification for a medical device: Shijiazhuang Hongxiang Plastic Products Co., Ltd. Pre-Powdered Sterile Vinyl Glove, Clear. This submission aims to prove substantial equivalence to a predicate device, not to directly establish efficacy against specific clinical outcomes in an AI/diagnostic context. Therefore, many of the typical questions for an AI/diagnostic device's acceptance criteria and studies (like MRMC studies, effect sizes, specific expert qualifications for ground truth) are not applicable to this type of device and submission.

However, I can extract the relevant "acceptance criteria" (performance standards and test results) and details of the studies conducted to meet those for this specific device.

Acceptance Criteria and Reported Device Performance

Study Details

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

   • Physical and Dimensions Testing: Sample size is indicated by "Inspection Level S-2, AQL4.0". Actual number of gloves not specified but implied to meet the AQL (Acceptable Quality Level) standard. Data provenance is implied to be from Shijiazhuang Hongxiang Plastic Products Co., Ltd., China.
   • Pinhole Test: Sample size is indicated by "AQL 2.5, Inspection Level I". Actual number of gloves not specified but implied to meet the AQL standard. Data provenance is implied to be from Shijiazhuang Hongxiang Plastic Products Co., Ltd., China.
   • Biocompatibility (Skin Irritation, Dermal Sensitization): Not specified beyond "rabbits" and "guinea pigs". Data provenance is implied to be from Shijiazhuang Hongxiang Plastic Products Co., Ltd., China, potentially through an external lab (Exhibit #4 is referenced).
   • Powder Limit Test: Not specified beyond "finished inspection". Data provenance is implied to be from Shijiazhuang Hongxiang Plastic Products Co., Ltd., China.
   • Sterilization Validation: Specific number of products for bioburden determination and sterilization cycle validation not explicitly stated, but methodology follows ANSI/ISO 11137. Data provenance is Radiation Health Research Institute of Hebei Province, China.
   • All studies are retrospective as they were conducted prior to the 510(k) submission.

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

   • Not Applicable. This is a device performance and safety study, not a diagnostic accuracy study requiring expert human interpretation as ground truth. The "ground truth" is established by direct measurement against a standard (e.g., amount of powder, number of pinholes, specific biological reactions in test animals).

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

   • Not Applicable. As above, this is not an expert-driven diagnostic accuracy study.

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 not an AI/diagnostic device.

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

   • Not Applicable. This is not an AI/diagnostic device.

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

   • The ground truth for most of these tests is based on objective measurement against established physical, chemical, and biological standards.
     • For physical/dimensional/pinhole tests: Direct measurement/count against ASTM standards.
     • For biocompatibility: Observed physiological reaction in animal models (absence of irritation/sensitization).
     • For powder limit: Gravimetric analysis against ASTM standard.
     • For sterility: Laboratory-determined bioburden and validation through microbial inactivation (SAL 10⁻⁶) according to ANSI/ISO 11137.

7. The sample size for the training set:

   • Not Applicable. This is not an AI/machine learning device that requires a training set.

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

   • Not Applicable. See above.

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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, Powder-Free Vinyl Patient Examination Glove, 80LYZ, and meets all requirements of ASTM Standard D-5250-00-4.

Here's a breakdown of the acceptance criteria and the study information for the "Powder Free Sterile Vinyl Glove (Clear & Yellow)" device, based on the provided text:

Acceptance Criteria and Device Performance

Study Details

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

   • The document mentions "samplings of AQL 2.5, Inspection Level I" for the water fill test and "Inspection Level S-2, AQL 4.0" for physical and dimensions testing. These are statistical sampling plans from ASTM standards, which define the number of units to be inspected from a lot and the maximum number of defects allowed for the lot to be accepted. However, the exact numerical sample size (e.g., how many gloves were tested in total for each test) is not explicitly stated.
   • Data Provenance: The tests were conducted by the manufacturer, Shijiazhuang Hongxiang Plastic Products Co., Ltd., presumably in China ("Shijiazhuang Hongxiang Plastic Products Co., Ltd. New High Technologies Industrial Zone Luquan City, Hebei, China"). The data is retrospective as it was collected before the 510(k) submission.

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 medical glove, and the "ground truth" for its performance is established through standardized physical, chemical, and biological tests, not through expert human interpretation or diagnosis.

3. Adjudication method for the test set:

   • Not applicable. As the "ground truth" is based on objective measurements against engineering standards, there is no need for expert adjudication. The results are quantitative (e.g., pass/fail a water leak test, measure powder content).

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 medical device (a glove), not an AI-powered diagnostic or interpretive tool. Therefore, MRMC studies involving human readers and AI are irrelevant.

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

   • Not applicable. This device is a physical product (a glove), not an algorithm or software. Its performance is assessed through direct physical and chemical testing.

6. The type of ground truth used:

   • Standardized Physical, Chemical, and Biological Tests. The ground truth is established by meeting predefined criteria set forth in recognized industry standards like ASTM D-5250-00, ASTM D5151-99, and ASTM D6124-01, as well as biocompatibility testing (primary skin irritation and sensitization).

7. The sample size for the training set:

   • Not applicable. The concept of a "training set" is relevant for machine learning algorithms. This product is a physical device, not an AI model. Its manufacturing process is controlled to meet specifications, but there isn't a training dataset in the AI sense.

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

   • Not applicable. As explained above, there is no "training set" in the context of an AI algorithm for this device. The manufacturing process is designed and verified to produce gloves that consistently meet the established performance standards.

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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, Powder-Free Vinyl Patient Examination Glove, 80L YZ, and meets all requirements of ASTM Standard D5250-00E4

The provided text describes the acceptance criteria and the study conducted for the Shijiazhuang Hongxiang Plastics Products Co., Ltd. Synthetic (Blue) Vinyl Patient Examination Gloves-Powder Free.

Here's the breakdown of the information requested:

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 a specific numerical sample size for the entire "test set." However, it mentions:

• For Physical and Dimensions Testing: "Inspection Level S-2, AQL 4.0" (AQL refers to Acceptance Quality Limit, a statistical sampling method for quality control, not a fixed sample size).
• For Water Fill Test: "samplings of AQL 2.5, Inspection Level I" (similar to above, a statistical sampling method).
• Data Provenance: Not explicitly stated, but assumed to be internal testing conducted by the manufacturer, Shijiazhuang Hongxiang Plastics Products Co., Ltd. Given the company's location, the data provenance would be from China. The studies are retrospective in the sense that they are conducted on finished products for quality control and regulatory 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 as the device is a medical glove, and its performance is evaluated against engineering and material standards, not by expert interpretation of complex medical data.

4. Adjudication method for the test set
Not applicable for this type of device and testing. Performance is measured against objective physical and chemical 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 device is a passive medical product (gloves) and does not involve AI or human "readers" in its function or evaluation.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithmic device. The "standalone" performance refers to the device's physical and chemical properties as measured in the non-clinical tests.

7. The type of ground truth used
The ground truth used is based on established industry standards and regulatory requirements, specifically:

• ASTM Standard D5250-00E4 (for general glove properties, physical, and dimensions)
• ASTM D-5151-99 (for pinhole detection via water fill test)
• ASTM D6124-01 (for residual powder measurement)
• Biocompatibility standards (for primary skin irritation and sensitization)
• 21 CFR 880.6250 and other applicable 21 CFR references (for regulatory classification and compliance)

8. The sample size for the training set
Not applicable. This is not a machine learning or AI device, 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, there is no ground truth to establish for it.

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Ask a specific question about this device

Ask a specific question about this device

Ask a specific question about 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 hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste or environment.

Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Powder-Free Vinyl Patient Examination Glove, 80LYZ, and meets all requirements of ASTM Standard D5250-92.

This document describes the acceptance criteria and the study conducted for the Shijiazhuang Hongxiang Plastics Products Co., Ltd. Synthetic Powder-Free Vinyl Patient Examination Gloves.

1. Table of Acceptance Criteria and Reported Device Performance

The device's performance is demonstrated through its conformance to established standards and tests for examination gloves.

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

• Sample Size:

  • For Physical and Dimensions Testing: Inspection Level S-2.
  • For FDA 1000 ml. Water Fill Test: Sampling AQL 2.5, Inspection Level S-4.
  • For Primary Skin Irritation and Skin Sensitization: Not explicitly stated, but standard biocompatibility testing involves a statistically relevant number of subjects/samples.
  • For USP Iodine Test: Routinely performed at finished inspection; specific sample size per batch not provided.

• Data Provenance: The studies were conducted by the device manufacturer, Shijiazhuang Hongxiang Plastics Products Co., Ltd., based in P.R. China. The studies are retrospective relative to the submission date, as they were performed to demonstrate compliance of existing product batches.

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

This device is a medical glove, and the "ground truth" for its performance is established by objective, standardized laboratory and materials testing, not by expert interpretation of medical images or conditions. Therefore, the concept of "experts" to establish ground truth in the traditional sense (e.g., radiologists interpreting images) is not applicable here. The "experts" involved would be qualified laboratory technicians and material scientists who conduct the tests according to published ASTM and FDA standards. Specific numbers or qualifications of these individuals are not provided in the summary.

4. Adjudication Method for the Test Set

Adjudication methods like 2+1 or 3+1 are typically used for subjective diagnostic assessments, particularly in imaging studies. For this device, the tests are primarily objective measurements against predefined thresholds set by ASTM standards and FDA guidelines (e.g., AQL levels for pinholes, pass/fail for irritation). Therefore, an adjudication method for conflicting expert opinions is not applicable. The results are quantitative or clearly pass/fail.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. This type of study is relevant for diagnostic devices where human readers interpret output (e.g., images), and the AI's effect on human performance is being evaluated. This device is an examination glove, which does not involve human interpretation in the same way.

6. Standalone Performance Study

Yes, a standalone performance study was conducted. The document describes several tests performed directly on the device (the gloves) to demonstrate its intrinsic properties and compliance with standards, independent of human interaction for interpretation purposes. These include:

• Physical and Dimensions Testing against ASTM D5250-92.
• FDA 1000 ml. Water Fill Test (for pinholes).
• Primary Skin Irritation testing.
• Skin Sensitization testing.
• USP Iodine Test for starch.

7. Type of Ground Truth Used

The ground truth used is primarily objective performance metrics and compliance with established industry standards and regulatory requirements. This includes:

• ASTM Standard D5250-92: For physical properties and dimensions.
• FDA 1000 ml. Water Fill Test requirements: For pinhole integrity.
• Biocompatibility guidelines: For primary skin irritation and sensitization.
• USP Iodine Test methodology: For confirming "powder-free" claims.
  These are well-defined, quantitative, or qualitative pass/fail criteria, rather than subjective expert consensus or pathology interpreted from patients.

8. Sample Size for the Training Set

The concept of a "training set" is relevant for machine learning algorithms. This device is a physical product (medical glove) and does not employ an AI algorithm or machine learning. Therefore, there is no training set in the context of AI development. The "training" for the manufacturing process involves adherence to Good Manufacturing Practices (GMP) and quality control, but not a data-driven training set for an AI model.

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

As stated in point 8, there is no training set for an AI algorithm. The manufacturing process and quality control for the gloves are based on established manufacturing specifications, material science principles, and quality assurance protocols that ensure the product consistently meets the performance standards outlined in Section 7.

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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 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, Powdered Vinyl Patient Examination Glove, 80LYZ, Powdered with Absorbable Dusting Powder, USP, Class III and meets all requirements of ASTM Standard D5250-92.

Here's a breakdown of the acceptance criteria and study information based on the provided text, formatted as requested:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for the Test Set and Data Provenance

The document does not explicitly state the sample sizes used for each specific test (e.g., Physical and Dimensions, Water Fill, Biocompatibility). It mentions:

• Physical and Dimensions Testing: Inspection Level S-2, AQL 4.0
• FDA 1000 ml. Water Fill Test: AQL 2.5, Inspection Level S-4

The data provenance is implied to be from Shijiazhuang Hongxiang Plastics Products Co., Ltd. in P.R. China, based on their testing of their own product. The studies appear to be retrospective in the sense that they were conducted on already manufactured products to ensure compliance.

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

This information is Not Applicable to this submission. The device is a patient examination glove, and the "ground truth" for its performance is established through standardized physical, chemical, and biological tests, not through expert interpretation of data like in medical imaging.

4. Adjudication Method for the Test Set

This information is Not Applicable as the ground truth is established through objective, standardized tests, not through subjective human interpretation requiring adjudication.

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

No, a MRMC comparative effectiveness study was not done. This type of study is relevant for comparing the performance of human readers with and without AI assistance, typically in diagnostic tasks. This device is a medical glove, which doesn't involve diagnostic reading.

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

This information is Not Applicable. The device is a physical product (a glove), not an algorithm or software. Therefore, the concept of "standalone performance" for an algorithm doesn't apply.

7. The Type of Ground Truth Used

The ground truth used for assessing this device's performance is based on standardized test specifications (ASTM D5250-92 and FDA Water Fill Test requirements) and biological test results (primary skin irritation and skin sensitization).

8. The Sample Size for the Training Set

This information is Not Applicable. There is no "training set" in the context of this device. The manufacturer produces a product and tests it against established standards. This is not an AI/machine learning model that requires training data.

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

This information is Not Applicable for the reasons stated in point 8.

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