Who we are
KMLT Medical develops single-use medical garments designed to support hygiene, comfort, and efficient workflow in procedural healthcare environments. Our products are intended for use in clinical settings to provide a clean, disposable barrier between clinicians and shared equipment. Focused on simple, practical solutions, KMLT Medical designs apparel that integrates seamlessly into hospital operations.
KMLT Medical products are medical garments intended for hygienic use in healthcare settings and are not classified as medical devices by the U.S. Food and Drug Administration.
Frequently Asked Questions
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No. This product is not a medical device and is not subject to FDA medical device regulation.
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No. This product is classified as a single-use medical garment, not a medical device.
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This product is a single-use medical garment intended for hygienic wear in healthcare and procedural environments. It is designed to provide a clean barrier between the wearer and shared protective equipment during routine fluoroscopy procedures. The garment is not intended to provide protection against radiation, fluids, or infectious agents and is not a medical device.
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No. This garment does not provide protection against radiation, bodily fluids, or infectious agents. It is intended solely as a hygienic barrier when wearing shared protective equipment.
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Yes. The materials used meet the following biocompatibility standards:
ISO 10993-5
ISO 10993-10 -
For questions, pricing, or ordering information, please contact us through our contact page. We aim to respond quickly, usually within 1-2 business days.