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A powdered surgeon's glove is a device made of natural or synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.

A powder-free surgeon's glove is a device made of natural or synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.

The Surgical Glove is made of all natural rubber, sterile, and powdered with USP absorbable dusting powder and contains less than 50 micrograms or less of protein content.

The provided text describes a 510(k) summary for surgical gloves, which are medical devices and not typically subject to the same kind of "AI model performance" studies as software algorithms. The request asks for details that are common for AI/ML device evaluations (e.g., sample size for test set, number of experts for ground truth, MRMC studies, standalone performance), but these are not relevant for the described device (surgical gloves).

Therefore, I will extract the available acceptance criteria and device performance based on the provided document. I will also explicitly state that the other requested information (sample size for test set, experts for ground truth, adjudication, MRMC, standalone performance, training set details) is not applicable or not provided for this type of device submission.

Here's the breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Additionally, the conclusion states the device meets "FDA requirements for water leak test on pinhole AQL" and "glove performance standards."

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

This information is not applicable or not provided for this type of medical device (surgical gloves). Device performance is typically evaluated against established ASTM and ISO standards, which define testing methodologies and sample sizes within those standard documents, rather than through independent "test sets" in the context of an AI/ML algorithm. The data provenance would refer to the materials and manufacturing process.

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 or not provided. The "ground truth" for surgical glove performance is established by the specified ASTM and ISO standards and their associated test methods, not by expert consensus on data interpretation.

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

This information is not applicable or not provided. Adjudication methods are relevant for subjective interpretations, often in image analysis or clinical diagnosis. Surgical glove testing involves objective physical, chemical, and biological tests.

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 or not provided. MRMC studies are used for evaluating the impact of diagnostic aids (often AI) on human reader performance. This submission is for a physical medical device (surgical gloves).

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

This information is not applicable or not provided. This concept applies to standalone software algorithms or AI models, not to physical devices like surgical gloves.

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

The "ground truth" for this device is based on objective measurements defined by international and national standards (ASTM D 3577-09e1, ASTM D 6124-06, ASTM D 5712-10, ISO 11137-2:2006) and established biocompatibility tests (Primary Skin Irritation in Rabbits, Dermal Sensitization). For instance, freedom from pinholes is measured by a water leak test, and protein level via a standard chemical assay.

8. The sample size for the training set

This information is not applicable or not provided. "Training set" refers to data used to train an AI/ML model, which is not relevant for surgical gloves.

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

This information is not applicable or not provided.

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This Powdered Latex Surgical Glove is a disposable device made of natural rubber latex material that bears powder to facilitate donning, and it is intended to be worn on the hands, usually in surgical setting, to provide a barner against potentially infectious materials and other contaminants.

Powdered Latex Surgeon's Glove

This is a 510(k) premarket notification for a powdered latex surgeon's glove. It is a traditional medical device submission and does not describe AI/ML software. Therefore, I cannot provide the requested information about acceptance criteria, study details, and AI/ML specific aspects.

The document discusses the regulatory classification of the device (Class I), general controls provisions, and the FDA's determination of substantial equivalence to legally marketed predicate devices. It also lists the "Indications for Use" for the glove, stating its purpose as a barrier against infectious materials in a surgical setting.

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A Sterile Powdered Latex Surgical Glove is a disposable device made of natural rubber latex and is intended to be worn by operating room personnel to protect a surgical wound from contamination.

Sterile Powdered Latex Surgical Gloves

The provided document is an FDA 510(k) clearance letter for "Maxter Sterile Powdered Latex Surgical Gloves." This document does not contain information about acceptance criteria and a study proving a device meets them in the context of an AI/ML medical device.

The document pertains to a medical device (surgical gloves) that undergoes a different type of regulatory review than AI/ML software. The letter confirms that the device is substantially equivalent to a legally marketed predicate device, primarily based on its materials and intended use, rather than performance metrics derived from complex data analysis.

Therefore, I cannot extract the requested information (acceptance criteria, study details, sample sizes, ground truth, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance) from this document. This kind of information is typically found in premarket submission summaries for AI/ML devices, not for basic medical consumables like surgical gloves.

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The Sensi Grip® Surgical Glove is a disposable device intended for medical use within hospitals and other healthcare facilities during invasive and non-invasive medical procedures requiring sterility. They are intended to be worn on the operating room personnel's hand to protect a surgical wound from contamination.

Natural Rubber Latex films form a barrier to body fluids and bloodborne pathogens. The latex 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. Natural Rubber Latex is known to create a barrier to bloodborne pathogens and and body fluids. ASTM conforming tensile properties create a glove that is strong and flexible. The leaching and washing process removes traces of chemical accelerants That may be chemically irritating. The glove is manufactured in accordance with the Requirements of ASTM D3577-00 and ASTM D5151-99 requirements.

{
  "1. A table of acceptance criteria and the reported device performance": {
    "Non-Clinical Tests": {
      "SPECIFICATION": [
        "PERFORMANCE STANDARDS",
        "WATER TIGHTNESS",
        "RESIDUAL PROTEIN"
      ],
      "ACCEPTANCE CRITERIA (Proposed Powdered Glove)": [
        "ASTM D3577-00: Meets or Exceeds Requirements",
        "ASTM D5151-99: Meets or Exceeds Requirements",
        "ASTM D5712-99: Meets or Exceeds Requirements"
      ],
      "REPORTED DEVICE PERFORMANCE (Proposed Powdered Glove)": [
        "Meets or Exceeds Requirements",
        "Meets or Exceeds Requirements",
        "Meets or Exceeds Requirements"
      ],
      "PREDICATE DEVICE PERFORMANCE": [
        "ASTM D3577-91: Meets or Exceeds Requirements",
        "ASTM D5151-92: Meets or Exceeds Requirements",
        "Not applicable (predicate did not have a protein labeling claim)"
      ]
    },
    "Clinical Tests": {
      "SPECIFICATION": [
        "SAFETY: SKIN IRRITATION",
        "SKIN SENSITIZATION"
      ],
      "ACCEPTANCE CRITERIA (Proposed Powdered Glove)": [
        "Meets or Exceeds Requirements",
        "Meets or Exceeds Requirements"
      ],
      "REPORTED DEVICE PERFORMANCE (Proposed Powdered Glove)": [
        "Meets or Exceeds Requirements",
        "Meets or Exceeds Requirements"
      ],
      "PREDICATE DEVICE PERFORMANCE": [
        "Meets or Exceeds Requirements",
        "Meets or Exceeds Requirements"
      ]
    }
  },
  "2. Sample sized used for the test set and the data provenance": "The document does not explicitly state the sample sizes used for the non-clinical and clinical tests. It only refers to meeting or exceeding ASTM standards and general safety requirements. The data provenance is implied to be from tests conducted by the manufacturer, Tillotson Healthcare Corporation, in the USA.",
  "3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts": "Not applicable. This is a medical device submission for surgical gloves, not a diagnostic device requiring expert interpretation of results to establish ground truth.",
  "4. Adjudication method for the test set": "Not applicable. This is a medical device submission for surgical gloves, not a diagnostic device requiring adjudication of results.",
  "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 a medical device submission for surgical gloves, not an AI-assisted diagnostic tool.",
  "6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done": "Not applicable. This is a medical device submission for surgical gloves, not an AI algorithm.",
  "7. The type of ground truth used": "For non-clinical tests (Performance Standards, Water Tightness, Residual Protein), the 'ground truth' is defined by adherence to established ASTM standards (D3577-00, D5151-99, D5712-99). For clinical tests (Skin Irritation, Skin Sensitization), the 'ground truth' is implied to be established through standard safety evaluations demonstrating the glove meets or exceeds safety requirements.",
  "8. The sample size for the training set": "Not applicable. This is a medical device submission for surgical gloves, not a machine learning model requiring a training set.",
  "9. How the ground truth for the training set was established": "Not applicable. This is a medical device submission for surgical gloves, not a machine learning model."
}

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A surgeon's glove is a device made of natural or synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.

Sterile Powdered Latex Surgical Gloves with Protein Labeling Claim ( 200 Micrograms or Less )

This document is a letter from the FDA regarding a 510(k) premarket notification for "Sterile Powdered Latex Surgical Gloves with Protein Labeling Claim (200 Micrograms or Less)."

It is important to understand that a 510(k) notification is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving a device meets specific acceptance criteria through a study with the detail you've requested for AI/software devices.

Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, expert involvement, and ground truth establishment will not be found in this document. This document focuses on the regulatory clearance process for a physical medical device (gloves), not a software or AI-driven diagnostic tool.

Information that CANNOT be Extracted from the Provided Document:

• A table of acceptance criteria and the reported device performance: This document does not detail specific performance metrics beyond the protein labeling claim.
• Sample size used for the test set and the data provenance: Not applicable to this type of device clearance.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
• Adjudication method: Not applicable.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical device, not an algorithm.
• The type of ground truth used: Not applicable in the context of AI/software ground truth.
• The sample size for the training set: Not applicable.
• How the ground truth for the training set was established: Not applicable.

Information that CAN be Extracted (and interpreted in the context of a 510(k) physical device):

1. A table of (implied) acceptance criteria and the reported device performance

While not structured as a typical "acceptance criteria" table for an AI study, the core claim being reviewed for this device is the "Protein Labeling Claim (200 micrograms or less)." The FDA's issuance of the 510(k) implies that the manufacturer provided sufficient data (likely through testing following recognized standards for surgical gloves) to substantiate this claim and demonstrate substantial equivalence to a predicate device.

Summary of "Study" (as implied by a 510(k) for this device):

The "study" for a 510(k) for a physical device like surgical gloves typically involves:

• Material Characterization: Demonstrating the material properties of the gloves meet relevant standards (e.g., ASTM, ISO) for strength, elasticity, freedom from holes, etc.
• Sterility Testing: Validating the sterilization process to ensure the gloves are sterile.
• Biocompatibility Testing: Ensuring the materials are safe for skin contact, often through tests like cytotoxicity, sensitization, and irritation.
• Protein Content Testing: Specific analytical testing methods (e.g., modified Lowry method, ELISA) to quantify the amount of extractable protein to substantiate the "200 micrograms or less" claim.
• Shelf-life Testing: Stability studies to ensure the device maintains its properties over its declared shelf life.

The 510(k) process primarily relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device, often by showing it meets recognized consensus standards (like ASTM D3577 for surgical gloves) and has the same technological characteristics and intended use, or that any differences do not raise new questions of safety or effectiveness. The document states a "protein labeling claim" of 200 micrograms or less, which would have been substantiated by specific testing.

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The surgeon's glove is a device made of natural rubber intended to be worn by surgeons and/or operating room personnel to protect a surgical wound from contamination.

Class II natural rubber latex surgeon's glove, 79 KGO, powdered with absorbable dusting powder. It meets all of the requirements of ASTM standard D3577-99.

This document describes the acceptance criteria and performance data for WRP Specialty Products Sdn Bhd's DERMAGRIP POWDERED LATEX SURGICAL GLOVE, STERILE (K993215).

1. Table of Acceptance Criteria and Reported Device Performance

Powder Weight Criteria:

Note: The document states "WRP Specialty Products Sdn. Bhd. SIZE 7½ ACTUAL POWDER WEIGHT mg/glove" for 204.7, and "External (Max) : 1.0% 0.96 140.0" implying 140.0 mg/glove for external powder. The "Internal" powder is given as 1.41% and 204.7 mg/glove. This implies that 204.7 mg is the internal powder weight for a Size 7 1/2 glove to be 1.41%, and 140.0 mg is the external powder weight for a Size 7 1/2 glove to be 0.96%.*

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

• Sample Size for Physical Requirement Test: 13 pieces per batch.
• Batch Size: 300,000 pairs (based on one consignment quantity).
• Data Provenance: Not explicitly stated, but given the company's location (Malaysia), the testing was likely conducted in Malaysia. The document does not specify if the data is retrospective or prospective, but for product quality control, it would typically be prospective for each batch produced.
• Sample Size for Powder Weight: Average over eight (8) pieces.

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

Not applicable. The ground truth for this device is established by objective physical and chemical measurements (tensile strength, elongation, powder weight) against specified standards (ASTM D3577-99, ASTM D412-87). No human expert interpretation of results is mentioned beyond standard laboratory practice.

4. Adjudication Method for the Test Set

The adjudication method for the physical requirement test is based on an Acceptance Quality Limit (AQL) system in accordance with ISO 2859/ANSI/ASQC Z1.4.

• AQL: 4.0
• Acceptance Criteria: 1 pc (meaning 1 or fewer defective pieces in the sample of 13)
• Rejection Criteria: 2 pcs (meaning 2 or more defective pieces in the sample of 13)

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 a medical device (surgical glove) for which AI assistance for human readers is not relevant. The testing focuses on the physical properties and sterility of the glove.

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

Not applicable. This is a physical medical device; there is no algorithm involved.

7. The Type of Ground Truth Used

The ground truth used is based on established industry standards and objective physical measurements:

• ASTM D 3577-99: Standard Specification for Rubber SURGICAL Gloves.
• ASTM D 412-87: Standard Test Methods for Rubber Properties in Tension.
• ISO 2859 / ANSI/ASQC Z1.4: Sampling Procedures and Tables for Inspection by Attributes.
• FDA watertight test requirements (mentioned in Attachment 7).

The ground truth for physical properties (Tensile Strength, Ultimate Elongation, Stress at 500% Elongation) and powder weight is derived from these standardized test methods and the acceptance criteria defined within them or by regulatory bodies.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI/ML algorithm. There is no concept of a "training set" in this context. Quality is assured by testing samples from production batches.

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

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

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LAGLOVE™ Brand Latex Surgical Gloves - Sterile (Powdered), containing 150 ugm or less of water extractable protein per gram is a disposable glove made of Natural Rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.

LAGLOVE™ Brand Latex Surgical Gloves - Sterile (Powdered) Containing 150 µgm or less of water Extractable protein per gram.

I am sorry, but the provided text does not contain the information required to describe the acceptance criteria and study detailed in the request. The document is an FDA 510(k) clearance letter for latex surgical gloves, focusing on regulatory approval and substantial equivalence, not on specific performance acceptance criteria or studies as typically applied to medical devices with measurable outputs like AI algorithms. Therefore, I cannot populate the requested table or answer the specific questions about sample sizes, ground truth, experts, or MRMC studies.

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