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A summary of safety and effectiveness information for a new surgical glove device intended for use in a surgical environment.
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How to fill out 510k summary of safety
How to fill out 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS PROTEXIS LATEX BASIC, STERILE LATEX POWDER-FREE SURGICAL GLOVES
01
Step 1: Gather necessary information about the Protexis Latex Basic gloves, including product specifications, intended use, and indications for use.
02
Step 2: Review the 510(k) submission guidelines provided by the FDA to ensure compliance with documentation requirements.
03
Step 3: Prepare the summary of safety and effectiveness, clearly detailing the safety data, effectiveness data, and any clinical evaluations.
04
Step 4: Include a comparison with predicate devices, highlighting similarities and differences to establish substantial equivalence.
05
Step 5: Compile any manufacturing information, quality control measures, and relevant regulatory history related to the gloves.
06
Step 6: Ensure all data is clearly presented, organized, and formatted as per FDA standards.
07
Step 7: Review the complete summary for accuracy and completeness before submission.
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Step 8: Submit the 510(k) summary electronically through the FDA’s submission portal.
Who needs 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS PROTEXIS LATEX BASIC, STERILE LATEX POWDER-FREE SURGICAL GLOVES?
01
Manufacturers of Protexis Latex Basic, Sterile Latex Powder-Free Surgical Gloves.
02
Distributors and wholesalers who wish to sell the gloves in the market.
03
Healthcare providers and institutions familiarizing themselves with the legal and safety standards of surgical gloves before usage.
04
Regulatory bodies or quality assurance teams ensuring compliance with FDA regulations.
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People Also Ask about
What is the difference between surgical gloves and latex gloves?
Both latex and vinyl gloves can be used for low-risk, general procedures such as a non-invasive physical exam. Surgical gloves are higher quality and designed specifically for the accuracy and sensitivity required by surgeons.
What are the best gloves for Raynaud's disease?
Gloves can be turned into dental dams (see document on dental dams) and finger s (see document on finger s). Do you have long nails that may puncture the glove or scratch your partner? Pro tip: Stuff the tips of the fingers with cotton balls or tissue before placing your hand in the glove.
What are Protexis gloves?
Synthetic polyisoprene surgical gloves produced on our unique surgical glove mold for an anatomical fit.
What are Kevlar gloves?
HotRox Double-Sided Electronic Hand Warmer and Raynaud's Disease Deluxe Silver Gloves Bundle HotRox Hand Warmer and Deluxe Silver Gloves. Ideal for preventing Raynaud's Disease. HotRox provides up to 6 hours of heat. Gloves help keep natural heat in.
What is protexis?
What Does Kevlar Gloves Mean? Kevlar gloves are a type of personal protective equipment (PPE) made of Kevlar, a strong synthetic fiber used to protect workers from cuts, abrasions and heat. The gloves are also lightweight, flexible and comfortable.
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What is 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS PROTEXIS LATEX BASIC, STERILE LATEX POWDER-FREE SURGICAL GLOVES?
The 510(K) Summary of Safety and Effectiveness for PROTEXIS LATEX BASIC, STERILE LATEX POWDER-FREE SURGICAL GLOVES is a regulatory submission required by the FDA that demonstrates a medical device's safety and efficacy. It provides evidence that the gloves are safe for use in medical procedures and comparable to other legally marketed devices.
Who is required to file 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS PROTEXIS LATEX BASIC, STERILE LATEX POWDER-FREE SURGICAL GLOVES?
Manufacturers or importers of medical devices, such as PROTEXIS LATEX BASIC, STERILE LATEX POWDER-FREE SURGICAL GLOVES, are required to file a 510(K) summary if they intend to market their devices and the devices do not have prior FDA approval.
How to fill out 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS PROTEXIS LATEX BASIC, STERILE LATEX POWDER-FREE SURGICAL GLOVES?
To fill out the 510(K) summary, manufacturers must complete forms that include device information, a description of intended use, safety and effectiveness data, a comparison to similar devices, labeling details, and any necessary performance testing results.
What is the purpose of 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS PROTEXIS LATEX BASIC, STERILE LATEX POWDER-FREE SURGICAL GLOVES?
The purpose of the 510(K) summary is to provide the FDA with sufficient information to assess whether the proposed device is safe and effective for its intended use and to determine if it is substantially equivalent to a previously cleared device.
What information must be reported on 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS PROTEXIS LATEX BASIC, STERILE LATEX POWDER-FREE SURGICAL GLOVES?
The information that must be reported includes the manufacturer's details, device classification, indications for use, a description of the device, comparison to predicate devices, performance testing data, labeling, and any adverse effects associated with the device.
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