(114 days)
BRIGHTWAY™ Brand Nitrile Examination Glove ( Powder Free, Chlorinated, Black Color ) is a disposable patient examination glove which is worn on the hand of healthcare and similar personnel to prevent contamination between patient and examiner.
BRIGHTWAY™ Brand Nitrile Examination Gloves (Powder Free, Chlorinated, Black Colour)
Here's an analysis of the provided text regarding acceptance criteria and study information:
The provided text describes two distinct medical devices and their respective 510(k) submissions. I will analyze the information for each separately as they don't seem to be related.
Device 1: SafeTip Safety Syringe (KOGO402)
This document mentions testing in a very general way and does not provide specific acceptance criteria or detailed study information. It states:
"The Devon SafeTip Safety Syringe has been shown to meet internationally recognized standards for syringe performance and labeling characteristics. Simulated clinical use testing has demonstrated the performance of the SafeTip syringe and reliability of the safety feature in accordance with the FDA Guidance: Medical Devices with Sharps Injury Prevention Features: August 9, 2005."
From this, we can infer that the device was tested against "internationally recognized standards for syringe performance" and the "FDA Guidance: Medical Devices with Sharps Injury Prevention Features: August 9, 2005." However, the specific metrics, thresholds, or details of the study itself are not present.
Given the information provided, it's impossible to fill out the requested table and answer many of the specific questions.
Device 2: BRIGHTWAY™ Brand Nitrile Examination Gloves (K060402)
This document is a 510(k) clearance letter for examination gloves. It does not contain any information about specific acceptance criteria or performance studies of the device. It primarily details the regulatory clearance process and refers to general controls. The "Indications for Use" section simply describes the intended use of the gloves.
Therefore, for this device, it's also impossible to fill out the requested table and answer the specific questions about acceptance criteria and studies.
Summary of Missing Information for BOTH Devices:
The provided texts are regulatory submission documents (or summaries thereof) that indicate a device has undergone testing and met certain standards, but they do not include the specific details of those tests, acceptance criteria, or study methodologies. To answer your questions fully, you would need access to the actual test reports or detailed study summaries that would have been part of the full 510(k) submission.
Attempting to fill what little can be inferred from the "SafeTip Safety Syringe" document, with heavy caveats:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Metric (Inferred) | Acceptance Threshold (Inferred) | Reported Device Performance (Inferred) |
|---|---|---|---|
| Syringe Performance | Not specified (e.g., fluid delivery accuracy, plunger force) | *Not specified (e.g., +/- X%, |
§ 880.6250 Non-powdered patient examination glove.
(a)
Identification. A non-powdered 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 non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.(b)
Classification. Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.