Pattana Latex Co., Ltd.
ThailandFDA applicant, unverified
- Devices
- 1
What Pattana Latex Co., Ltd. makes
Pattana Latex Co., Ltd. manufactures patient examination gloves made from latex, designed for single-use medical procedures and clinical examinations. These gloves are intended to provide barrier protection for both healthcare providers and patients during direct contact with bodily fluids or contaminated surfaces.
The company’s latex examination gloves are classified as Class I medical devices under FDA regulations and are listed via the 510(k) pathway. The products are intended for use within the United States, adhering to applicable FDA compliance requirements for low-risk devices.
Catalogue
Patient Examination Gloves (Latex) Ref K892170
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Pattana Latex Co., Ltd. have in the registry?
The registry currently lists 1 device for Pattana Latex Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Pattana Latex Co., Ltd.'s devices?
Among its 1 most recently registered device, Pattana Latex Co., Ltd. has devices listed in FDA 510(k) (1 device).
What risk classes do Pattana Latex Co., Ltd.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Pattana Latex Co., Ltd.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Pattana Latex Co., Ltd. in the registry?
The most recently registered devices listed for Pattana Latex Co., Ltd. include PATIENT EXAMINATION GLOVES (LATEX).