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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.

The powder free nitrile examination glove is manufactured from synthetic rubber latex. Inner surface of gloves undergo surface treatment process to produce a smooth surface that assists the user in donning the gloves with ease without using any lubricant such as powder on the glove surface. The glove is ambidextrous; i.e. can be worn on right hand or left hand.

The provided 510(k) summary (K132354) describes the acceptance criteria and performance of a Powder Free Blue Nitrile Patient Examination Glove, Non-Sterile. This device is a medical glove, and its evaluation relies on established ASTM (American Society for Testing and Materials) standards and FDA regulations, rather than clinical studies involving human or expert readers.

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

1. Table of Acceptance Criteria and Reported Device Performance

• Before Aging: Tensile Strength min 14 MPa, Ultimate Elongation Min 500%
• After Aging: Tensile Strength min 14 MPa, Ultimate Elongation Min 400% |
  | Thickness | ASTM D6319-10 | Meets (Finger min 0.05mm, Palm min 0.05mm) |
  | Powder Free | ASTM D6124-06 (Reapproved 2011) | Meets (≤ 2 mg/glove) |
  | Biocompatibility | Primary Skin Irritation: ISO 10993-10:2010(E) & Consumer Product Safety Commission, Title 16, Chapter II, Part 1500 | Passes (Not a primary skin irritant - PII of test material "0"; no erythema or oedema noted) |
  | | Dermal Sensitization: ISO 10993-10:2010(E) & Consumer Product Safety Commission, Title 16, Chapter II, Part 1500.3(c)(4) | Passes (Not a contact sensitizer; no positive allergic reaction observed during challenge phase) |
  | Watertight | ASTM D5151-06 (Reapproved 2011) | Passes (AQL 2.5) |
  | Intended Use | | 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. |
  | Material | ASTM D6319-10 | Nitrile, Sulphur, Zinc Oxide, Zinc Dibutyldithiocarbamate (ZDBC), Zinc Diethyldithiocarbamate (ZDEC), Phenolic Antioxidant, Titanium Dioxide, Blue Pigment |
  | Color | - | Blue |
  | Texture | - | Finger textured |
  | Size | Medical Glove Guidance Manual - Labeling | Extra Small, Small, Medium, Large, Extra Large |
  | Single Use | Medical Glove Guidance Manual - Labeling | Single use |

Study Details:

This submission is for a medical glove, not an AI or imaging diagnostic device. Therefore, many standard questions related to studies involving human readers, AI algorithms, and complex ground truth establishment are not applicable. The device's performance is demonstrated through adherence to recognized physical, chemical, and biological standards.

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

   • The document does not specify the exact sample sizes for each test (e.g., how many gloves were tested for dimensions, physical properties, etc.).
   • Data Provenance: The tests are based on established ASTM standards and ISO guidelines, suggesting controlled laboratory testing environments. The country of origin of the data is not explicitly stated beyond the Malaysian address of the submitter, implying the testing was either conducted in Malaysia or contracted to a lab adhering to international standards. The data is retrospective in the sense that it represents the results of finished product testing.

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

   • Not applicable. Ground truth for medical gloves is not established by human experts in the same way it would be for a diagnostic imaging device. Instead, ground truth is defined by the objective measurements and parameters outlined in the ASTM and ISO standards (e.g., a glove is watertight if it passes the AQL 2.5 leakage test, not based on an expert's opinion).

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

   • Not applicable. This concept is relevant for subjective assessments or ambiguous cases, commonly found in diagnostic imaging or clinical trials. For glove performance, the standards dictate objective pass/fail criteria.

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 type of study is specifically for evaluating the impact of AI on human reader performance, typically in diagnostic tasks.

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

   • Not applicable. This device is not an algorithm or an AI system. Its performance is inherent in its physical and material properties.

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

   • The ground truth for this device is defined by objective physical, chemical, and biocompatibility standards and measurements as specified by ASTM (e.g., D6319-10 for physical characteristics, D6124-06 for powder residue, D5151-06 for watertightness) and ISO (e.g., 10993-10:2010(E) for biocompatibility).

7. The sample size for the training set:

   • Not applicable. This device does not use machine learning or AI, so there is no concept of a "training set."

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

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

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