Est International Corporation
United StatesFDA 510(k) applicant, unverified
- Devices
- 4
What Est International Corporation makes
Est International Corporation manufactures disposable powder-free vinyl synthetic exam gloves in various formulations, including standard white gloves, vitamin-enriched variants with nopal and lanolin, and colored options. These gloves are designed for single-use medical examinations and procedures, providing barrier protection for healthcare professionals.
The company’s products are classified as Class I medical devices under FDA regulations and are listed via the 510(k) pathway. These devices are intended for use in the United States, where the manufacturer is based.
Catalogue
- 510(k) 510(k)
Opue-E Disposable Powder Free Vinyl Synthetic Exam Gloves With Vitamin Complex, Nopal And Lanolin Ref K040108
510(k) 510(k)- 510(k) 510(k)
- 510(k) 510(k)
Frequently asked questions
How many devices does Est International Corporation have in the registry?
The registry currently lists 4 devices for Est International Corporation. Devices recorded under merged duplicate company entries are counted once.
Which registries list Est International Corporation's devices?
Among its 4 most recently registered devices, Est International Corporation has devices listed in FDA 510(k) (4 devices).
What risk classes do Est International Corporation's devices fall under?
Among its 4 most recently registered devices, the classes recorded for Est International Corporation's devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Est International Corporation in the registry?
The most recently registered devices listed for Est International Corporation include DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WHITE COLOR, OPUE-E DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WITH VITAMIN COMPLEX, NOPAL AND LANOLIN, DISPOSABLE POWERED VINYL SYNTHETIC EXAM GLOVES, WHITE COLOR and DISPOSABLE COLORED VINYL SYNTHETIC EXAM GLOVE, POWDER FREE.