Search Results

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

These gloves were tested for use with chemotherapy drugs per ASTM D6978-05 (Reapproved 2013) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.

The subject device in this 510(k) Notification is a Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs

The subject device is a patient examination glove made from nitrile compound, blue in color, powder free and non-sterile (as per 21 CFR 880.6250, class I).

The principle operation of the medical device to provide single use barrier protection for the wearer and the device meets all the requirement specifications for Barrier Protection, tensile properties as defined in ASTM D6319-10, Standard specification for Nitrile Examination Gloves.

This document describes the acceptance criteria and performance study for the Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs (K171873).

1. Table of Acceptance Criteria and Reported Device Performance

Chemotherapy Drug Permeation Performance:

Note: The document highlights that Carmustine (BCNU) and Thiotepa have "extremely low permeation times" and a warning statement is to be included in labeling for these specifically.

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

The document does not specify a distinct "test set" in terms of a dataset of items being classified or evaluated by an algorithm or human readers. Instead, it refers to bench tests conducted on the device itself.

• Sample Size: Not explicitly stated for each specific test (e.g., number of gloves tested for pinholes, physical properties, or chemotherapy permeation). The general statement is "Bench tests were conducted to verify that the proposed device met all specifications."
• Data Provenance: The tests are described as "Bench tests" which are typically laboratory-based and prospective in nature for a new device. The country of origin for the data is not specified, but the applicant company is Zhonghong Pulin Medical Products Co., Ltd. located in China.

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

This information is not applicable to this type of device submission. The "ground truth" for glove performance is established through adherence to recognized international standards (e.g., ASTM, ISO) and regulatory requirements (e.g., 21 CFR 800.20), not through expert consensus on a test set of data. The performance is objectively measured against predefined criteria in these standards.

4. Adjudication Method for the Test Set

Not applicable. As noted above, performance is measured against objective standards, not through consensus or adjudication of expert interpretations.

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

No. This type of study is not relevant for a medical device like an examination glove. MRMC studies are typically used for evaluating diagnostic imaging or AI algorithms where human interpretation plays a significant role.

6. Standalone Performance Study (Algorithm Only Without HIL)

No. This device is a physical medical glove and does not involve AI algorithms or human-in-the-loop performance evaluation in the context of an algorithm. The "device performance" refers to the physical and chemical properties of the glove itself.

7. Type of Ground Truth Used

The "ground truth" for evaluating the glove's performance is based on established industry standards and regulatory requirements. This includes:

• ASTM D6319-10: Standard Specification for Nitrile Examination Gloves for Medical application (Dimension, Physical Properties, Powder Residual).
• 21 CFR 800.20 & ASTM D5151-06 (2011): Freedom from pinholes.
• ASTM D6124-06 (2011): Standard Test Method for Residual Powder on Medical Gloves.
• ISO 10993-10:2010: Biocompatibility (Primary Skin Irritation, Dermal Sensitization).
• ASTM D6978-05 (Reapproved 2013): Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.

8. Sample Size for the Training Set

Not applicable. This device is not an AI algorithm that requires a training set. Its performance is evaluated through physical and chemical testing.

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

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

Ask a specific question about this device

Nitrile Powder Free Patient Examination Gloves, Blue Color is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Nitrile films form a barrier to body fluids and bloodborne Pathogens. The nitrile 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. Nitrile glove is known to create a barrier to bloodborne pathogens and body fluids. ASTM conforming tensile properties create a glove that is strong and flexible. The glove is manufactured in accordance with the requirements of ASTM D6319 and ASTM D5151 requirements.

The provided document is a 510(k) summary for the Nitrile Powder Free Patient Examination Gloves, Blue Color (K152712). This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving a novel device meets specific acceptance criteria through a clinical study involving AI or human readers.

Therefore, many of the requested fields are not applicable to the context of this document.

Here's the information that can be extracted from the provided text, formatted to address your request:

Acceptance Criteria and Device Performance

Study Details (Based on the Provided Document which is a 510(k) Summary)

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

   • The document does not specify general "test set" sample sizes or data provenance in the context of clinical studies for performance evaluation of a device like an AI. Instead, it refers to compliance with ASTM standards and biocompatibility studies. The specific sample sizes for tests like pinhole detection, tensile strength, or biocompatibility are not detailed, but implied to be sufficient for standard compliance.
   • Data Provenance: Not explicitly stated for each test, but the submitter is Zhonghong Pulin Medical Products Co., Ltd. from Hebei, China. Biocompatibility studies specify rabbits and guinea pigs.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

   • Not applicable. This is a medical glove, not an AI diagnostic device requiring expert interpretation for ground truth. Ground truth for its performance properties is established through standardized physical, chemical, and biological testing as per ASTM and ISO standards.

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

   • Not applicable. This concept is relevant for studies where human interpretation of medical data and subsequent consensus is needed to establish ground truth (e.g., in diagnostic AI), which is not the case for a patient examination glove.

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 medical glove, not an AI system or software requiring comparison of human reader performance with and without AI assistance.

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

   • Not applicable. This is a physical medical device (glove), not an algorithm.

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

   • The "ground truth" for the device's performance is established by conformance to established industry standards (ASTM D6319-10, ASTM D6124-06, ASTM D5151-06, 21 CFR 800.20) and biocompatibility testing results (ISO 10993-10). For example, "Freedom from pinholes" has a ground truth defined by the water leak test method described in 21 CFR 800.20. Biocompatibility has ground truth based on observed biological reactions in animal models.

8. The sample size for the training set:

   • Not applicable. This device does not involve machine learning or AI models with training sets.

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

   • Not applicable. This device does not involve machine learning or AI models with training sets.

Ask a specific question about this device