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Powder Free Latex Examination Gloves, Non Sterile (contains 50 micrograms/dm² or less of total water extractable protein) is a disposable device and made of Natural Rubber Latex intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Powder Free Latex Examination Gloves, Non Sterile (contains The 50 micrograms/dm² or less of total water extractable protein) is Class I Device. These gloves are made of natural rubber latex. The gloves can be used either right or left hand (ambidextrous), Disposable, Single Use and Non Sterile. The Specification of this device meets the requirements of ASTM Standard D 3578 - 05 and FDA 1000ml Water Leak Test.

Here's a breakdown of the acceptance criteria and the study information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

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A powder-free 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.

A powder-free 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.

Here's a breakdown of the acceptance criteria and study information for the "Powderfree Latex Examination Gloves" described in the provided documents:

The documents provided are a 510(k) Summary and an FDA substantially equivalent letter for "Powderfree Latex Examination Gloves" manufactured by PT. Maja Agung Latexindo. This type of regulatory filing demonstrates substantial equivalence to a predicate device, rather than proving performance against novel acceptance criteria through a full-fledged clinical study.

Therefore, the study design and "acceptance criteria" here refer to meeting established industry standards for similar devices and demonstrating equivalence to a legally marketed predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated in the provided documents. For physical property testing of gloves adhering to ASTM standards, specific sample sizes are typically defined within the ASTM standard (e.g., ASTM D3578-05ae2 for latex examination gloves specifies sampling plans for various tests like dimensions, physical properties, and watertightness).
• Data Provenance: The manufacturing location is "Jln. Utama No. 98 PUJI MULYO SUNGGAL - DELI SERDANG SUMATERA UTARA - INDONESIA". The testing data would originate from the manufacturer's quality control or third-party testing facilities related to their manufacturing process. The data is retrospective, as it refers to tests conducted on manufactured batches to ensure compliance with the standard.

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

• This question is not applicable in the context of this 510(k) submission. The "ground truth" for the performance specifications of these gloves is defined by the ASTM D 3578-05ae2 Standard and FDA's pinhole requirements. These are engineering and performance specifications, not subjective expert interpretations of medical images or outcomes. The "experts" involved would be the engineers and quality control personnel who conducted the tests and verified compliance with the standard.

4. Adjudication Method for the Test Set

• This is not applicable. Adjudication methods are typically for subjective assessments (e.g., medical image interpretation). The tests conducted for glove performance (tensile strength, elongation, dimensions, pinhole) are objective measurements against a defined standard.

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 not a study involving human readers or AI assistance. It is a device 510(k) submission for examination gloves, which are physical medical devices, not diagnostic software.

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

• Not applicable. This is not an algorithm or software device.

7. The Type of Ground Truth Used

• The ground truth used is established industry standards and regulatory requirements, specifically:
  • ASTM D 3578-05ae2 Standard for Powder-Free Latex Examination Gloves
  • FDA pinhole requirement for examination gloves.
  • The specifications defined in the 510(k) summary for dimensions and physical properties, which are derived from or meet these standards.

8. The Sample Size for the Training Set

• Not applicable. There is no "training set" in the context of this device manufacturing and regulatory submission. The gloves are manufactured and tested against predefined specifications.

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

• Not applicable, as there is no training set for this type of device. The specifications for performance (ground truth) were established over time through industry consensus and regulatory guidance, leading to standards like ASTM D 3578-05ae2.

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Blue Powder Free Latex Examination Gloves, Non-Sterile is a disposable medical device made from natural rubber latex compound. It is intended to be worn on the hands as a barrier against potentially infectious materials and other contamination.

Latex Patient Examination Gloves, LYY, Powder Free

The provided text describes a 510(k) submission for Blue Powder Free Latex Examination Gloves, Non-Sterile. This submission focuses on medical gloves, which are physical products, not an AI/ML powered device. As such, the concept of "acceptance criteria" and "study" in the context of an AI/ML device's performance metrics (like accuracy, sensitivity, specificity, sample sizes for training/test sets, ground truth establishment, expert adjudication, MRMC studies, or standalone performance) is not applicable here.

The document primarily addresses the glove's compliance with established industry standards and FDA requirements for medical devices, specifically patient examination gloves.

Here's a breakdown of the relevant information provided, adapted to the context of a medical glove:

1. Table of Acceptance Criteria and Reported Device Performance:

The document broadly states that the device "meets ASTM D 3578-01 Standard and FDA's requirement" for quality performance. It also states the device "pass the Biocompatibility Test." Specific numerical performance metrics (like AQL levels for pinholes) are not detailed in this excerpt but would be part of the underlying test reports.

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

• Test Set Sample Size: Not explicitly stated in the provided text for the quality performance or biocompatibility tests. These would typically be specified in the full test reports referenced by the 510(k) submission.
• Data Provenance: The manufacturing entity is MultiSafe Sdn. Bhd. located in Malaysia. The testing would have been conducted to meet US FDA requirements and international standards (ASTM D 3578, ISO 11193, EN 455). The origin of the raw data/samples tested would be from the manufacturing process in Malaysia.

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

This concept is not applicable for a medical glove submission. Ground truth for a physical medical device like a glove is established through adherence to standardized physical, chemical, and biological testing protocols, not expert consensus on interpretations.

4. Adjudication method for the test set:

This concept is not applicable for a medical glove submission. Adjudication is relevant for diagnostic interpretations, not for physical product testing against standardized specifications.

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 concept is not applicable as this is a medical glove, not an AI-powered diagnostic device.

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

This concept is not applicable as this is a medical glove, not an algorithm.

7. The type of ground truth used:

For a medical glove, the "ground truth" is defined by:

• Standardized Physical and Performance Specifications: E.g., ASTM D 3578-01 for dimensions, tensile strength, elongation, and barrier integrity (absence of pinholes at specified AQL levels).
• Biocompatibility Standards: Absence of irritation or sensitization as determined by standardized in-vivo (animal or human patch) tests.
• Chemical Properties: Compliance with limits for extractable proteins (for latex gloves) if applicable.

8. The sample size for the training set:

This concept is not applicable as this is a medical glove. There is no "training set" in the context of an AI/ML algorithm. The "training" for glove manufacturing would refer to process control and quality system implementation.

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

This concept is not applicable as this is a medical glove.

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Powder Free Latex Examination Gloves, Non-Sterile (Contains 50 micrograms or less of Water Extractable Protein per gram) is a disposable device and made of Natural Rubber Latex intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

The Powder Free Latex Examination Gloves, Non Sterile (Contains 50 micrograms or less of Total Water Extractable Protein per gram) meets all the requirements of ASTM standard D 3578 - 01a 22 and FDA 1000 ml Water Leak Test.

Here's an analysis of the provided text regarding the acceptance criteria and study for the PT. Mandiri Inti Buana examination gloves:

Overview:

This submission describes a Class I medical device (Powder Free Latex Examination Gloves, Non-Sterile) and seeks a 510(k) clearance based on substantial equivalence to legally marketed predicate devices. The "study" here refers to non-clinical performance testing conducted to demonstrate compliance with established standards.

1. Table of Acceptance Criteria and Reported Device Performance

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The 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 Latex Examination Gloves, Non Sterile with Protein Content Labeling Claim (50 Micrograms or less) meets all the requirements of ASTM standard D 3578 -- 01a"22 and FDA 21.CFR 800.20.

Here's an analysis of the provided text regarding the acceptance criteria and study for the "Powder Free Latex Examination Gloves, Non Sterile with Protein Content Labeling Claim (50 Micrograms or less)":

It's important to note that this 510(k) summary is for a medical device (gloves), not an AI algorithm. Therefore, many of the typical questions related to AI studies (like sample size for test sets, ground truth establishment by experts, MRMC studies, standalone algorithm performance, or training set details) are not applicable or not provided in this type of submission.

The document primarily focuses on demonstrating that the gloves meet established industry standards and regulatory requirements.

1. Table of Acceptance Criteria and Reported Device Performance:

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The Powder Free Latex Examination Gloves, Non-Sterile (Protein Content Labeling 50 µg/g or less) is a disposable device and made of Natural Rubber Latex intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Powder Free Latex Examination Gloves, Non Sterile (Protein Content Labeling 50 ug/q or less) is Class I Device, Code No. 80LYY. These gloves are made of natural rubber latex. Based on the protein content test result obtained the aloves are well bellow 50 ug/g and support our protein content labeling claim.

The provided text describes a 510(k) summary for "Glovetex Powder Free Latex Examination Gloves, Non Sterile (Protein Content Labeling Claim 50ug/g or less)". This document is a premarket notification for a medical device and, as such, focuses on demonstrating substantial equivalence to a predicate device rather than presenting a comprehensive study on a new device's performance against detailed acceptance criteria for an AI/algorithm.

The "acceptance criteria" and "device performance" in this context refer to the physical and chemical properties of the gloves themselves, compared against established standards for examination gloves and the specific protein content claim. The "study" described is the testing conducted on the gloves to demonstrate conformance to these standards and the protein content claim.

Here's an attempt to structure the information based on the provided request, interpreting "acceptance criteria" and "device performance" in the context of this medical device submission:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify the exact sample size used for each specific test (e.g., protein content, ASTM D 3578, water leak test). It generally states that "The result of the performance testing... are detailed in this submission."

• Sample Size: Not explicitly stated for the test set of gloves.
• Data Provenance: The manufacturing company is PT. WRP Buana Multicorpora, located in Indonesia. The testing would have been conducted by or for this manufacturer. The document doesn't specify if the data is retrospective or prospective, but performance testing for a 510(k) submission typically involves prospective testing of production samples.

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

This type of information (number of experts, their qualifications, and ground truth establishment) is typically relevant for studies involving human interpretation (e.g., image analysis, clinical diagnosis). For the physical and chemical testing of examination gloves, "ground truth" is established by laboratory measurements and adherence to specified testing protocols (e.g., ASTM standards). Therefore, this question is not directly applicable in the conventional sense to this device. The "experts" would be qualified laboratory technicians or engineers performing the tests.

4. Adjudication Method for the Test Set

Again, adjudication methods like 2+1 or 3+1 are primarily used for reaching consensus among multiple human reviewers/experts, particularly in studies involving subjective interpretation. For objective laboratory tests on gloves, adjudication is not typically performed in this manner. The results are based on direct measurement and comparison to predefined thresholds.

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 evaluating diagnostic or interpretive devices (e.g., AI in radiology) where human readers are involved. This submission is for physical examination gloves.

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

No, this pertains to a physical medical device (examination gloves), not an algorithm or AI. Therefore, a standalone performance study in the context of "algorithm only" is not applicable.

7. The Type of Ground Truth Used

The "ground truth" for the performance claims of these gloves is based on:

• Laboratory Testing Results: Direct measurements of physical properties (e.g., water leak test) and chemical properties (e.g., protein content determination).
• Adherence to Established Standards: Conformance to recognized industry standards such as ASTM D 3578.

8. The Sample Size for the Training Set

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

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

This question is not applicable, as there is no training set for this device.

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The 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 patient examination glove may also provides additional protection in other areas where users are handling certain hazardous chemical such as commonly used chemotherapy drugs, as penetration and permeation by these drugs are resisted.

The Powder Free Latex Examination Gloves, Non Sterile with Protein Content Labeling Claim (50 Microgram or less) and Tested for Use with Chemotherapy Drugs meets all the requirements of ASTM standard D 3578 - 0151 and FDA 21 CFR 800.20.

Here's a breakdown of the acceptance criteria and study information for the "Dermagrip Powder Free Latex Examination Gloves" based on the provided 510(k) summary:

This device is a medical glove, and the studies performed are for validating performance characteristics against established ASTM (American Society for Testing and Materials) and FDA standards, not for evaluating an AI algorithm's diagnostic performance. Therefore, many of the requested categories related to AI studies (e.g., sample size for training, ground truth for training, MRMC studies, standalone algorithm performance, number of experts for ground truth, adjudication methods) are not applicable to this type of device and study.

Acceptance Criteria and Reported Device Performance

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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.

Powder Free Latex Examination Gloves

This document is a 510(k) clearance letter from the FDA for "Powder Free Latex Exam Gloves, Non-Sterile with Protein Labeling Claim 50 Microgram or Less." It is a regulatory approval document and does not contain information about acceptance criteria or a study proving device performance in the context of a statistical study with sample sizes, expert ground truth, or an MRMC study.

The letter explicitly states: "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976..."

This means the device's clearance is based on its substantial equivalence to a predicate device already on the market, not on a standalone performance study with specific acceptance criteria that are detailed in this document.

Therefore, I cannot provide the requested information from this document. The document primarily focuses on regulatory approval based on "substantial equivalence."

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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.

POWDER FREE LATEX EXAMINATION GLOVES, NON-STERILE

This document is a 510(k) clearance letter from the FDA for "Powder-Free Latex Examination Gloves, Non-Sterile". It does not contain information about acceptance criteria or a study proving device performance as the request pertains to, but rather is a notification of substantial equivalence for a medical device.

Therefore, I cannot extract the requested information from the provided text.

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