Shangrila Latex Industries Pvt., Ltd.
IndiaFDA applicant, unverified
- Devices
- 3
What Shangrila Latex Industries Pvt., Ltd. makes
Shangrila Latex Industries manufactures powder-free examination gloves and surgical gloves designed for medical and procedural use, including those compliant with Medicare requirements. Their product line includes nitrile-free latex alternatives intended for patient and user safety during clinical examinations and surgical procedures.
These devices are classified as Class I under FDA regulations and are listed via the 510(k) pathway. The company’s products are registered in the United States, where they are subject to compliance with FDA standards for medical gloves.
Catalogue
Medicare Gloves Ref K895021
Regimes: 510(k) Registry: 510(k)Nil Latex Powderfree Examination Gloves Ref K955341
Regimes: 510(k) Registry: 510(k)Surgeon's Gloves Ref K894087
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Shangrila Latex Industries Pvt., Ltd. have in the registry?
The registry currently lists 3 devices for Shangrila Latex Industries Pvt., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Shangrila Latex Industries Pvt., Ltd.'s devices?
Among its 3 most recently registered devices, Shangrila Latex Industries Pvt., Ltd. has devices listed in FDA 510(k) (3 devices).
What risk classes do Shangrila Latex Industries Pvt., Ltd.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Shangrila Latex Industries Pvt., Ltd.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Shangrila Latex Industries Pvt., Ltd. in the registry?
The most recently registered devices listed for Shangrila Latex Industries Pvt., Ltd. include MEDICARE GLOVES, NIL LATEX POWDERFREE EXAMINATION GLOVES and SURGEON'S GLOVES.