FDA Requirements for First aid kits


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Hello everyone,

I am trying to determine what are the requirements for selling first aid kits in USA.
The first aid kits will include medical gloves, BZK swabs and alcohol prep pads.
The suppliers of the medical gloves, BZK swabs and alcohol prep pads will be FDA approved for these products.

What needs to be done to get clearance of the first aid kits?

Thank you in advance for your help!

Hi Danny,

Good question. The FDA has separate procedures and guidance (this might be old but can get you on the right track) for kits that you can read here: Convenience Kits Interim Regulatory Guidance

From my quick read-through - the bottom line is that for certain kits, if the components have 510(k)s then the kits don't require a separate 510(k). But my experience is very limited with this as we only supply medical gloves to a company that includes them in their kidney dialysis kits - so don't take my word for it!

Good luck!

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