Ergo Intl., Ent., Inc.
United StatesFDA 510(k) applicant, unverified
- Devices
- 5
What Ergo Intl., Ent., Inc. makes
Ergo Intl., Ent., Inc. manufactures a range of latex patient examination gloves, including both sterile and non-sterile variants. Their product line includes surgical latex gloves, as well as gloves manufactured by Shun Tahi Rubber and Shun Jun Trading Co. These items are designed for clinical and medical examinations.
The company’s devices are classified under FDA’s Class I regulatory category and are listed via the 510(k) pathway. Their products are intended for use in the United States, where they comply with applicable medical device regulations.
Catalogue
- 510(k) 510(k)
Ergo Ii, Surgical Latex Gloves Ref K884030
510(k) 510(k)Non-Sterile Patient Exam Gloves (Latex) Ref K892166
510(k) 510(k)Prolax Patient Examination Gloves (Latex) Ref K892026
510(k) 510(k)Patient Exam Gloves (Mfg. Shun Jun Trading Co.) Ref K892100
510(k) 510(k)
Frequently asked questions
How many devices does Ergo Intl., Ent., Inc. have in the registry?
The registry currently lists 5 devices for Ergo Intl., Ent., Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Ergo Intl., Ent., Inc.'s devices?
Among its 5 most recently registered devices, Ergo Intl., Ent., Inc. has devices listed in FDA 510(k) (5 devices).
What risk classes do Ergo Intl., Ent., Inc.'s devices fall under?
Among its 5 most recently registered devices, the classes recorded for Ergo Intl., Ent., Inc.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Ergo Intl., Ent., Inc. in the registry?
The most recently registered devices listed for Ergo Intl., Ent., Inc. include PATIENT EXAM GLOVES (MFG. SHUN TAHI RUBBER GLOVES), ERGO II, SURGICAL LATEX GLOVES, NON-STERILE PATIENT EXAM GLOVES (LATEX) and PROLAX PATIENT EXAMINATION GLOVES (LATEX).