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

Powder Free Nitrile Examination Gloves meets all the current specifications listed under the ASTM Specification D6319-00a, Standard Specification for Nitrile Examination Gloves for medical Application.

This document describes the acceptance criteria and performance data for non-sterile, powder-free nitrile examination gloves.

1. Table of Acceptance Criteria and Reported Device Performance

The performance data of the gloves shown above meet the ASTM D6319-00a Standard and FDA's requirements.

Study Information:

This document is a 510(k) summary for a medical device and provides performance data based on established standards rather than a typical clinical study with patient data. Therefore, some of the requested information (like sample size for test/training sets from patient data, ground truth establishment by experts for medical AI, MRMC studies) is not applicable in this context.

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

The document refers to performance data based on ASTM D6319-00a and FDA 1000ML watertight test.

• Sample Size: Not explicitly stated as a single "test set" in terms of patient cases. The ASTM standard specifies how many gloves from a lot must be sampled and tested for each criterion (e.g., AQL for watertightness). The number of individual gloves tested for each property (length, width, thickness, physical properties, powder content) would be determined by the specific sampling plans outlined in ASTM D6319-00a.
• Data Provenance: The manufacturing company is stated as ULTRAWIN SDN BHD in Malaysia. The testing was conducted to meet international standards (ASTM) and FDA requirements. Therefore, the data originates from testing conducted by or for the manufacturer, likely in Malaysia or accredited testing facilities. The data is retrospective in the sense that it's a report of tests already performed on manufactured products.

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

Not applicable in the context of glove performance testing against technical standards. The "ground truth" for these tests is defined by the objective measurement methods and specifications within ASTM D6319-00a and FDA regulations. These are quantitative measurements that do not require expert consensus for interpretation in the way clinical diagnostic image interpretation would.

4. Adjudication Method for the Test Set:

Not applicable. The tests are based on objective measurements against specified ranges or thresholds (e.g., minimum length, maximum powder content, AQL for pinholes). There is no "adjudication" in the sense of resolving disagreements between human evaluators.

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 is relevant for diagnostic or screening devices involving human interpretation (e.g., radiologists reading images) and comparison of performance with and without AI assistance. This document pertains to the physical and barrier properties of examination gloves.

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

Not applicable. This is a physical product, not a software algorithm. The "performance" is the inherent property of the glove itself, measured directly.

7. The Type of Ground Truth Used:

The "ground truth" for the device's performance is based on objective measurement against established technical standards and regulatory requirements.

• ASTM D6319-00a Standard: This standard provides the specific test methods, acceptable ranges, and sampling plans for nitrile examination gloves.
• FDA Pinhole Requirements: Specifically, the 1000ml watertight test with an AQL of 2.5 is a regulatory requirement for barrier integrity.
• FDA Requirements for Powder Content: Stipulating a maximum of 2.0 mg/glove.
• Biocompatibility Tests: Primary Dermal Irritation Test and Guinea Pig Sensitization Test.

8. The Sample Size for the Training Set:

Not applicable. This is not an AI/machine learning device that requires a training set of data.

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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A non sterile powder free latex exam glove intended for medical purposes that is worn on the examiner's hands to prevent contamination between the patient and examiner.

SINGLE USE, DISPOSABLE, BLUE COLOR, POWDER FREE LATEX PATIENT EXAMINATION GLOVE WITH COLLOIDAL OATMEAL USP WITH A PROTEIN CLAIM OF 50 MICROGRAM OR LESS PER GRAM OF GLOVE

The provided text is a letter from the FDA regarding a 510(k) premarket notification for a medical device: "Single Use, Disposable, Blue Color, Powder Free Latex Patient Examination Glove with Colloidal Oatmeal USP with a Protein Claim of 50 Microgram or Less Per Gram of Glove."

This document does not contain any information about acceptance criteria, device performance tables, study designs, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone algorithm performance, or ground truth establishment.

Instead, the letter:

• Confirms the FDA has reviewed the 510(k) submission (K072802).
• Determines the device is "substantially equivalent" to legally marketed predicate devices.
• Grants permission to market the device under general controls.
• Specifies the regulatory class (Class I) and product code (LYY).
• Outlines general regulatory compliance requirements.
• Includes an "Indications for Use Statement" for the glove.

Therefore, I cannot provide the requested information from this document. The document primarily serves as an FDA clearance letter based on substantial equivalence, not a detailed report of device performance studies.

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A patient examination glove is a disposable device intended for medical purposes worn on the examiner's hand to prevent contamination between patient and examiner.

Extra-Care Powder Free Latex Patient Examination Glove - Polymer Coated

I am sorry, but based on the provided text, there is no information about the acceptance criteria and study proving device meets the acceptance criteria. The document is a 510(k) clearance letter from the FDA for a patient examination glove, confirming its substantial equivalence to a predicate device. It does not contain details about specific performance criteria, study designs, sample sizes, expert qualifications, or ground truth establishment for the device.

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A patient examination glove is a disposable device intended for medical purposes worn on the examiner's hand to prevent contamination between patient and examiner.

Extra-Care Latex Powder-Free Examination Glove

The provided text does not contain information about acceptance criteria or a study proving that the device meets those criteria. This document is a 510(k) clearance letter from the FDA for a medical device, specifically "Extra-Care Latex Powder-Free Examination Glove."

The letter confirms that the device is substantially equivalent to legally-marketed predicate devices, allowing it to be marketed. It discusses regulatory classifications, general controls, and compliance with manufacturing practices.

Here's why the requested information cannot be extracted from this document:

• Acceptance Criteria/Performance Data: The letter focuses on regulatory approval based on "substantial equivalence" to a predicate device, not on specific performance metrics or acceptance criteria for the new device itself. It doesn't present any test results or performance tables.
• Study Details: There is no mention of any specific study conducted by the applicant (Ultrawin Sdn. Bhd.) to demonstrate performance, including:
  • Sample size or data provenance.
  • Details about experts or ground truth establishment.
  • Adjudication methods.
  • MRMC studies or effect sizes.
  • Standalone algorithm performance.
  • Ground truth types.
  • Training set details.

The "Indications for Use Statement" section defines what the device is (a disposable glove for medical purposes) and its intended use (to prevent contamination between patient and examiner), but it does not specify any performance standards or criteria that the glove must meet beyond general safety and effectiveness implied by the regulatory clearance.

Therefore, I cannot populate the requested table or provide answers to the specific study-related questions based on the input text.

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