Danpren Gloves A/S
DK Last updated 22 Oct 2026
- Devices
- 1
- Registries
- FDA 510(k)
- FDA recalls
- 0
Catalogue
Elastyren - Examination And Dental Gloves Ref K901394
What Danpren Gloves A/S makes
Danpren Gloves A/S manufactures examination and dental gloves under the brand Elastyren, designed for single-use protection in clinical and dental settings. These gloves are made from a specific elastomer compound to provide durability and tactile sensitivity during procedures.
The company’s products fall under FDA Class I devices and are listed via the 510(k) pathway. The manufacturer is based in the United States.
Frequently asked questions
What types of medical devices does Danpren Gloves A/S manufacture?
Danpren Gloves A/S specializes in single-use examination and dental gloves under the brand Elastyren. These gloves are engineered for clinical and dental procedures, prioritizing protection and tactile sensitivity through a proprietary elastomer compound.
Where is Danpren Gloves A/S based?
Danpren Gloves A/S operates from the United States, serving as its headquarters and primary manufacturing location for its medical glove products.
Which regulatory registries or databases list Danpren Gloves A/S devices?
Danpren Gloves A/S devices are listed in the FDA’s 510(k) registry, as they are classified under FDA Class I. This pathway is used for low-risk devices that do not require pre-market approval but must still demonstrate compliance with regulatory requirements.
How are Danpren Gloves A/S devices classified by regulatory authorities?
Danpren Gloves A/S devices, including Elastyren examination and dental gloves, are classified as FDA Class I devices. This classification applies to products posing minimal risk to users, often requiring only general controls (like good manufacturing practices) rather than specialized pre-market submissions.
Information
- Country
- DK