Search Results
Found 12 results
510(k) Data Aggregation
(77 days)
A medical glove is worn on the hand of healthcare and similar personnel to prevent contamination between health care personnel and the patient.
OmniGrace Latex Examination Glove, Powder Free, Polymer Coated with Protein Claim
The provided document is an FDA 510(k) premarket notification letter for a medical device: "Omni Grace Latex Examination Glove, Powder Free, Polymer Coated with Protein Claim." This document confirms the substantial equivalence of the device to legally marketed predicate devices and allows it to be marketed.
However, the document does not contain any information regarding the acceptance criteria, device performance, or any studies that prove the device meets specific performance criteria. The FDA letter itself states that "FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements and statutes and regulations administered by other Federal agencies." It primarily focuses on the regulatory clearance process based on substantial equivalence to existing devices, not on a detailed analysis of performance studies.
Therefore, I cannot provide the requested information, including:
- A table of acceptance criteria and reported device performance.
- Sample sizes or data provenance for test sets.
- Number and qualifications of experts for ground truth.
- Adjudication method for a test set.
- Information on Multi-Reader Multi-Case (MRMC) comparative effectiveness studies or effect sizes.
- Results of standalone algorithm performance.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
This document is a regulatory approval letter, not a technical report detailing performance studies.
Ask a specific question about this device
(27 days)
Ask a specific question about this device
(36 days)
A medical glove is worn on the hand of healthcare and similar personnel to prevent contamination between health care personnel and the patient.
OmniGrace Latex Examination Glove, Powdered, with Protein Claim (100 Micrograms or Less)
This document is a marketing clearance letter from the FDA for a medical device, specifically, the OmniGrace Latex Examination Glove. It does not contain information about acceptance criteria or a study proving device performance as it is primarily concerned with regulatory clearance rather than a technical performance report.
Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, study details, sample sizes, expert qualifications, or ground truth establishment from the provided text.
Ask a specific question about this device
(71 days)
A medical glove is worn on the hand of healthcare and similar personnel to prevent contamination between health care personnel and the patient.
Omni Flex Nitrile Examination Glove, Powder Free
I am sorry, but I cannot provide a table of acceptance criteria and reported device performance or other detailed study information based on the provided text. The documents are FDA 510(k) clearance letters and an "Indications For Use Statement" for an "Omni Flex Nitrile Examination Glove, Powder-Free".
These documents do not contain any information about performance studies, acceptance criteria, sample sizes, expert qualifications, ground truth establishment, or comparative effectiveness studies (MRMC).
The provided text primarily focuses on:
- Regulatory Clearance: The FDA's determination that the device is "substantially equivalent" to legally marketed predicate devices.
- Product Information: Device name, applicant, and intended use (as stated in the "Indications For Use Statement").
- Regulatory Requirements: Mention of general controls provisions, potential additional controls for Class II/III devices, and compliance with Good Manufacturing Practice.
To answer your request, I would need a different type of document, such as a clinical study report, a regulatory submission summary that includes performance data, or a publication detailing the device's validation.
Ask a specific question about this device
(71 days)
A medical glove is worn on the hand of healthcare and similar personnel to prevent contamination between health care personnel and the patient.
Omni Touch Nitrile Examination Glove, Powdered, Purple
I am sorry, but the provided text does not contain the information required to describe the acceptance criteria and the study proving the device meets them. The document is an FDA 510(k) clearance letter for "Omni Touch Nitrile Examination Glove, Powdered, Purple," which confirms the device's substantial equivalence to predicate devices and permits its marketing.
The letter and the attached "Indications For Use Statement" do not detail:
- Specific acceptance criteria for the device beyond its intended use as a medical glove.
- Any performance study, sample sizes, data provenance, ground truth establishment, expert qualifications, adjudication methods, or comparative effectiveness studies.
Therefore, I cannot fulfill your request with the provided information.
Ask a specific question about this device
(63 days)
A medical glove is worn on the hand of healthcare and similar personnel to prevent contamination between health care personnel and the patient.
Omni Flex Nitrile Examination Glove, Powder Free, Purple
This document is a 510(k) premarket notification decision letter from the FDA regarding "Omni Nitrile Flex Examination Glove, Powder-Free, Purple." It does not contain information about the acceptance criteria and study proving device performance as requested in the prompt.
Therefore, I cannot extract the requested information from the provided text. The document is a regulatory approval letter, not a scientific study report.
Ask a specific question about this device
(62 days)
A medical glove is worn on the hand of healthcare and similar personnel to prevent contamination between health care personnel and the patient.
OmniGrace Latex Examination Glove, Powder Free, Polymer Coated, with Protein Claim ( 50ug or less )
The provided text is a 510(k) premarket notification decision letter from the FDA to OmniGrace (Thailand) Ltd. for their Latex Examination Glove, Powder-Free, Polymer Coated, with Protein Content Labeling Claim (50 Micrograms or Less). This document states the FDA's determination of substantial equivalence to a legally marketed predicate device, thereby allowing the device to be marketed.
Crucially, the provided text does NOT contain information about acceptance criteria, device performance, test set sample size, ground truth establishment, or any details about a study conducted to prove the device meets acceptance criteria.
The letter is an administrative document, confirming regulatory clearance based on substantial equivalence to an existing device, rather than a report detailing a new study or performance evaluation with specific acceptance criteria as you've requested.
Therefore, I cannot extract the information you've requested from the provided text.
Ask a specific question about this device
(62 days)
A medical glove is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient.
Omni Touch Nitrile Examination Glove, Powdered, White
I am sorry, but because the document is a scanned image, I cannot provide details on the study and acceptance criteria. My current capabilities do not allow me to extract and process information from documents in image format.
Ask a specific question about this device
(118 days)
A medical glove is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient.
OmniGrace Latex Examination Glove, Powder Free, with Protein Claim
This document is a 510(k) premarket notification for a medical device: "OmniGrace Latex Examination Glove, Powder-Free, with Protein Claim."
Based on the provided text, there is no information available regarding the acceptance criteria for a device's performance, nor any study proving the device meets said criteria.
The document is an FDA letter acknowledging receipt and review of the 510(k) submission, and confirming that the device, an examination glove, is substantially equivalent to legally marketed predicate devices. It discusses regulatory classifications, general controls, and compliance requirements.
Therefore, I cannot answer the specific questions about acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness as these details are not present in the provided text.
Ask a specific question about this device
(37 days)
A glove to be worn by operating room personnel to protect a surgical wound from contamination.
Not Found
This document is a 510(k) clearance letter from the FDA for a medical device called "Omni Pro Latex Surgical Glove, Powdered." This type of document does not contain the information requested in the prompt, as it is a regulatory clearance and not a study report or technical specification.
Therefore, I cannot provide the detailed information about acceptance criteria, study design, expert qualifications, or ground truth establishment based on the provided text. This letter confirms that the device is substantially equivalent to a predicate device and can be marketed, but does not include the performance study details you are asking for.
Ask a specific question about this device
Page 1 of 2