21st Century Group
US Last updated 23 May 2026
Is this your brand? Sign in to claim this brand
- Devices
- 1
- Registries
- FDA 510(k)
- FDA recalls
- 0
Catalogue
Digiflex, Latex Patient Examination Gloves Ref K910542
What 21st Century Group makes
The company manufactures DIGIFLEX latex patient examination gloves, a sterile barrier device designed for single-use in clinical examinations and procedures.
These gloves are classified as Class I under FDA regulations and are listed via 510(k) clearance. The manufacturer operates from the United States.
Frequently asked questions
What types of medical devices does 21st Century Group manufacture?
21st Century Group specializes in manufacturing DIGIFLEX latex patient examination gloves, which are sterile, single-use gloves designed as a barrier during clinical examinations and procedures. These gloves fall under the category of sterile barrier devices, ensuring protection for both patients and healthcare providers.
Where is 21st Century Group based?
The company operates from the United States, where its manufacturing and development activities are conducted.
How are the company’s devices classified under FDA regulations?
The DIGIFLEX latex patient examination gloves produced by 21st Century Group are classified as Class I devices under FDA regulations. This classification applies to devices posing minimal risk to patients, often involving general controls like good manufacturing practices (GMP) and labeling requirements.
Are the company’s devices listed in any regulatory registries?
Yes, the company’s DIGIFLEX latex patient examination gloves are listed via FDA 510(k) clearance, a premarket submission process demonstrating substantial equivalence to a legally marketed predicate device. This clearance allows the device to be legally marketed in the U.S.
Information
- Country
- US