Hygienex Corp.
PH Last updated 22 Oct 2026
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- Devices
- 1
- Registries
- FDA 510(k)
- FDA recalls
- 0
Catalogue
Hygienex Examination Gloves Ref K922903
What Hygienex Corp. makes
Hygienex Corp. manufactures examination gloves designed for single-use medical and clinical procedures, providing barrier protection for healthcare professionals.
These products are classified as Class I devices under FDA regulations and are listed via the 510(k) pathway. The company is based in the United States.
Frequently asked questions
What types of medical devices does Hygienex Corp. manufacture?
Hygienex Corp. specializes in single-use examination gloves, which are primarily used in medical and clinical settings to provide barrier protection for healthcare professionals during procedures. These gloves are designed to reduce the risk of contamination and ensure hygiene standards are met.
Where is Hygienex Corp. based?
Hygienex Corp. is headquartered in the United States. The company’s location supports its focus on manufacturing and distributing medical devices tailored to global healthcare needs.
How are Hygienex Corp.’s devices classified under FDA regulations?
Hygienex Corp.’s examination gloves fall under Class I device classification according to FDA regulations. This classification is typically assigned to low-risk devices where general controls are sufficient to ensure safety and effectiveness, such as single-use gloves with minimal risk of harm.
Which regulatory registries or pathways are Hygienex Corp.’s devices listed under?
Hygienex Corp.’s examination gloves are listed via the FDA’s 510(k) pathway, a premarket submission required for Class I devices that are not exempt from notification. This pathway demonstrates that the device is substantially equivalent to a legally marketed predicate device, ensuring compliance with FDA requirements.
Information
- Country
- PH