Hycare Intl. Co., Ltd.
Country not established
- Devices
- 3
What Hycare Intl. Co., Ltd. makes
Hycare Intl. Co., Ltd. manufactures single-use latex examination gloves, including powdered and powder-free variants, as well as powdered latex exam gloves with reduced protein content (≤200 µg/g). These products are designed for medical and clinical examinations to provide barrier protection and tactile sensitivity.
The company’s portfolio is classified under FDA’s Class I regulatory category and is listed via 510(k) clearance in the United States. The devices are intended for general medical use without requiring additional premarket approval beyond compliance with FDA standards.
Catalogue
Hycare Latex Examination Glove, Powder Free Ref K020042
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Hycare Latex Examination Glove, Powdered Ref K010875
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Hycare Intl. Co., Ltd. have in the registry?
The registry currently lists 3 devices for Hycare Intl. Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Hycare Intl. Co., Ltd.'s devices?
Among its 3 most recently registered devices, Hycare Intl. Co., Ltd. has devices listed in FDA 510(k) (3 devices).
What risk classes do Hycare Intl. Co., Ltd.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Hycare Intl. Co., Ltd.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Hycare Intl. Co., Ltd. in the registry?
The most recently registered devices listed for Hycare Intl. Co., Ltd. include HYCARE LATEX EXAMINATION GLOVE, POWDER FREE, POWDERED LATEX EXAM GLOVES WITH PROTEIN LABELING (200UG/G OR LESS) and HYCARE LATEX EXAMINATION GLOVE, POWDERED.