Search Results

This is a medical glove to be worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient.

Class I latex patient examination glove 80LZA, powder free and meeting all the requirements of ASTM-D3578-61) Standard Specification for Latex Examination Gloves for Medical Application, except for the elongation at break parameter.

This document describes the acceptance criteria and performance of the "POWDER-FREE, 'BARRIER-PRO™, SYNTHETIC BUTADIENE CO-POLYMER EXAM GLOVES, COLOR: GREEN" manufactured by Shield Gloves, as submitted for 510(k) clearance (K011613).

1. Table of Acceptance Criteria and Reported Device Performance

Note: The device explicitly states that it meets/exceeds ASTM-D3578 Standard Specifications for Latex Examination Gloves, except for the elongation at break parameter. However, the provided tables show that the "Ultimate Elongation" for the Shield Gloves exceeds the ASTM-D3578-00 requirement for both before and after aging. This might be a misunderstanding of the "elongation at break parameter" or an older ASTM standard being referenced in the summary text. Based on the provided table, the performance for Ultimate Elongation is better than the ASTM standard.

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

• Water Tight Test: 125 pieces per size (X-Small, Small, Medium, Large) for both un-aged and aged gloves. This totals 1000 gloves tested specifically for the water leak test (4 sizes * 125 gloves/size * 2 aging conditions).
• Tensile Strength & Ultimate Elongation: The data is reported for each size (X-Small, Small, Medium, Large) for both before and after aging. The specific number of samples tested for these mechanical properties is not explicitly stated, but it is reported for "Lot# 1128".
• Residual Powder Content: The range (0.7-1.5mg/glove) and mean (1.05 mg/glove) suggest multiple samples were tested, but the total sample size is not specified.
• Data Provenance: The document does not explicitly state the country of origin for the data or whether it was retrospective or prospective. Given that Shield Gloves Manufacturing (M) Sdn Bhd is the applicant and is located in Malaysia (implied by "Sdn. Bhd." and context), it is highly likely the testing was conducted by or for the manufacturer, presumably in Malaysia, as part of their product development and regulatory submission. The testing would be considered prospective for the purpose of this 510(k) submission.

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

Not applicable. This device is a medical glove, and its performance is evaluated against engineering and material standards (e.g., ASTM D3578) and regulatory requirements (e.g., FDA water leak test, biocompatibility, powder content). Ground truth is established by these objective standards and tests, not by expert interpretation of clinical images or subjective assessments typically requiring expert consensus.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like 2+1 or 3+1 are used for subjective assessments (e.g., in clinical trials or image interpretation) where multiple experts might disagree on an outcome. For objective physical and chemical tests of a medical glove, the results are typically quantitative measurements or pass/fail criteria based on defined standards, not requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

Not applicable. This device is a physical medical glove and does not involve AI or human "readers" in its intended use or evaluation.

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

Not applicable. This device is a physical medical glove and does not involve an algorithm.

7. The Type of Ground Truth Used

The ground truth for most of the performance criteria is based on established industry standards and regulatory requirements:

• ASTM-D3578-00/99: "Standard Specification for Latex Examination Gloves for Medical Application" (for Dimension, Tensile Strength, Ultimate Elongation).
• FDA specified water leak test: A specific methodology for determining watertight integrity.
• Biocompatibility standards: Tests for dermal irritation and skin sensitization.
• ASTM D 6124-00: For Residual Powder Content.
• FDA claim criterion: For a powder-free glove (presence of cornstarch).

These standards define the objective and measurable criteria for acceptable performance.

8. The Sample Size for the Training Set

Not applicable. This device is a physical medical glove, not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning. The manufacturing process of physical goods involves quality control and process validation, which might use statistical sampling (e.g., during production runs) but is distinct from an AI training set.

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

Not applicable, as there is no training set for this physical device.

Ask a specific question about this device

Ask a specific question about this device

Ask a specific question about this device

This is a medical glove to be worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient.

Class I latex patient examination gloves 80LYY, powdered and meeting all the requirements of ASTM-D3578-99 Standard Specification for Latex Examination Gloves for Medical Application.

The provided text describes the acceptance criteria and performance data for ROYAL SHIELD POWDERED LATEX EXAMINATION GLOVES, rather than a typical AI-driven device. As such, many of the requested categories in the prompt (e.g., sample size for test set, number of experts, adjudication method, MRMC study, training set size, etc.) are not applicable to the documentation provided for this type of medical device clearance.

However, I can extract the relevant information regarding acceptance criteria and reported performance from the document.

Acceptance Criteria and Reported Device Performance for ROYAL SHIELD POWDERED LATEX EXAMINATION GLOVES

1. Table of Acceptance Criteria and Reported Device Performance

Ask a specific question about this device

A medical glove to be worn on the hand of the health care and similar personnel to prevent contamination between health care personnel and patient.

Class I latex patient examination gloves 80L Y Y, powdered and meeting all the requirements of ASTM-D3578-99 Standard Specification for Latex Examination Gloves for Medical Application.

This document describes the acceptance criteria and performance data for ROYAL SHIELD PINK COLORED POWDERED LATEX EXAMINATION GLOVES WITH AND WITHOUT STRAWBERRY SCENTING & A PROTEIN LABELLING CLAIM.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

Ask a specific question about this device

This is a medical glove to be worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient.

Class I latex patient examination gloves 80LYY, powdered and meeting all the requirements of ASTM-D3578-99 Standard Specification for Latex Examination Gloves for Medical Application.

The provided text describes the acceptance criteria and performance data for ROYAL SHIELD BLUE COLORED POWDERED LATEX EXAMINATION GLOVES. This document does not pertain to an AI-powered device or software for medical imaging analysis. Therefore, many of the requested points, such as those related to AI effectiveness, ground truth establishment for AI, expert qualifications, and training/test sets for algorithms, are not applicable.

Here's the information that can be extracted based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Ask a specific question about this device

This is a medical glove to be worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient.

Class I latex patient examination gloves 80LYY, powder free and meeting all the requirements of ASTM-D3578-95 Standard Specification for Latex Examination Gloves for Medical Application.

This document describes the acceptance criteria and supporting studies for the ROYAL SHIELD POWDER FREE LATEX EXAMINATION GLOVES WITH BUBBLE GUM SCENT AND PROTEIN CONTENT LABELING.

1. Table of Acceptance Criteria and Reported Device Performance

• X-Small: 2 leaked (1%)
• Small: 2 leaked (1%)
• Medium: 1 leaked (0.5%)
• Large: 4 leaked (2%)
  (All percentages are within 4.0% AQL) |
  | Biocompatibility - Primary Dermal Irritation Test | Must not be a primary irritant | Not a primary irritant |
  | Biocompatibility - Skin Sensitization Study | Must not be a sensitizer | Not a sensitiser |
  | Residual Powder Content (per ASTM D 6124-97) | 2 mg/glove max (FDA internal requirement) | Range: 1.5 - 1.9 mg/glove (Mean: 1.7 mg/glove) |
  | Presence of Cornstarch | Negative | Negative |
  | Residual Protein Level (per ASTM D 5712-95) |

Ask a specific question about this device

A medical glove to be worn on the hand of the health care and similar personnel to prevent contamination between health care personnel and patient.

Class I latex patient examination gloves 80LYY, powder free and meeting all the requirements of ASTM-D3578-95 Standard Specification for Latex Examination Gloves for Medical Application.

The provided text describes the acceptance criteria and performance of "ROYAL SHIELD POWDER FREE GREEN LATEX EXAM GLOVES." This is a Class I medical device (examination gloves), and the study conducted focuses on demonstrating its physical and chemical properties meet established standards, rather than evaluating an AI-powered diagnostic or therapeutic device. Therefore, many of the requested elements pertaining to AI studies (like MRMC, ground truth establishment for AI, expert qualifications, adjudication methods, training/test set sizes for AI algorithms) are not applicable to this type of device and study.

Here's a breakdown of the acceptance criteria and reported device performance based on the provided text:

Acceptance Criteria and Reported Device Performance

Ask a specific question about this device

This is a medical glove to be worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient.

Class I latex patient examination gloves 80LYY, powder free and meeting all the requirements of ASTM-D3578-95 Standard Specification for Latex Examination Gloves for Medical Application.

I am sorry. I cannot fulfill this request. The provided text describes the safety and effectiveness of latex examination gloves, which is a medical device, but it lacks the specific information required to address your questions about acceptance criteria for an AI/ML powered medical device. The text does not mention any AI or machine learning components, nor does it detail studies involving human readers or ground truth established by experts in the context of AI.

Ask a specific question about this device

This is a medical glove to be worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient.

Class I Nitrile patient examination gloves 80LZA, powder free and meeting all the requirements of the ASTM Draft Standard Specification for Nitrile Examination Gloves for Medical Application.

The provided text describes the acceptance criteria and the study that proves the device, SMART SHIELD™ POWDER FREE COLORED NITRILE EXAMINATION GLOVES WITH BUBBLE GUM SCENT, meets these criteria.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

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

For the water-tightness test, the sample size used was 200 pieces for each glove size (Small, Medium, M-Large, Large). This suggests a total of 800 gloves were tested for water tightness.
The data provenance is from the manufacturer's internal testing (Shield Gloves Mfr's), conducted to meet FDA and ASTM standards. The specific country of origin is Malaysia (Shield Gloves Manufacturer (M) Sdn. Bhd.). The data appears to be prospective as it involves direct testing of manufactured batches.

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

The document does not specify the number of experts or their qualifications for establishing ground truth for any of the tests. The tests performed (dimension, physical properties, water leak, biocompatibility, residual powder) are objective measurements against established ASTM and FDA standards, not subjective expert assessments.

4. Adjudication Method for the Test Set

No adjudication method is described, as the tests rely on objective measurements and pass/fail criteria against predefined standards (ASTM, FDA). There is no indication of a need for expert adjudication for these specific performance metrics.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices involving human interpretation of results (e.g., radiology images) to assess the impact of AI on human reader performance. For examination gloves, the performance metrics are largely objective and physical.

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

Yes, the studies described are all standalone performance evaluations of the glove itself. There is no algorithm or human-in-the-loop component relevant to the testing presented. The device is a physical product, not an AI or software-as-a-medical-device.

7. The Type of Ground Truth Used

The ground truth for all evaluated parameters were established standards and specifications:

• ASTM D3578-95 and ASTM DRAFT NITRILE for dimensions, tensile strength, and ultimate elongation.
• FDA specified 1,000 ml water leak test and ASTM D 5151-90 for water tightness.
• FDA biocompatibility requirements for primary dermal irritation and skin sensitization.
• FDA internal requirements (not exceeding 2 mg/glove) for residual powder content, measured by ASTM D 6124.
• Negative Iodine test for cornstarch presence.

8. The Sample Size for the Training Set

This information is not applicable as the device is a physical product (nitrile gloves) and 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 for the same reason as above; there is no training set for a physical medical glove.

Ask a specific question about this device