Gigantic International Corp.
United StatesFDA applicant, unverified
- Devices
- 3
What Gigantic International Corp. makes
Gigantic International Corp. manufactures single-use patient examination gloves made of vinyl and latex, including sterile latex surgeon’s gloves. These products are designed for medical, dental, and clinical examination procedures to provide barrier protection and reduce contamination risk.
The company’s portfolio is regulated under FDA’s Class I device classification, with products listed via the 510(k) pathway. These gloves are intended for use in the United States, where they comply with applicable FDA requirements for medical gloves.
Catalogue
Patient Examination Gloves (Vinyl) Ref K892766
Regimes: 510(k) Registry: 510(k)Sterile Latex Surgeon's Gloves Ref K894928
Regimes: 510(k) Registry: 510(k)Latex Patient Examination Gloves Ref K892923
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Gigantic International Corp. have in the registry?
The registry currently lists 3 devices for Gigantic International Corp.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Gigantic International Corp.'s devices?
Among its 3 most recently registered devices, Gigantic International Corp. has devices listed in FDA 510(k) (3 devices).
What risk classes do Gigantic International Corp.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Gigantic International Corp.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Gigantic International Corp. in the registry?
The most recently registered devices listed for Gigantic International Corp. include PATIENT EXAMINATION GLOVES (VINYL), STERILE LATEX SURGEON'S GLOVES and LATEX PATIENT EXAMINATION GLOVES.