Sanrea Healthcare Products Pvt, Ltd.
IndiaFDA applicant, unverified FDA
- Devices
- 3
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA establishment
What Sanrea Healthcare Products Pvt, Ltd. makes
Sanrea Healthcare Products manufactures sterile examination and surgical gloves, including powder-free nitrile and latex varieties designed for patient and procedural use. The gloves are intended for single-use in clinical, medical, and laboratory settings to maintain hygiene and barrier protection.
The company’s products are classified under FDA’s Class I regulatory category and are listed via the 510(k) pathway. These devices are intended for distribution in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
SANCARE STERILE LATEX EXAMINATION GLOVES (also marketed as GLOVTEK STERILE LATEX EXAMINATION GLOVES) Ref K171367
Regimes: 510(k) Registry: 510(k)Sterile Latex Surgical Gloves, Powder Free Ref K171550
Regimes: 510(k) Registry: 510(k)
FDA establishments
- Sanrea Healthcare Products Pvt Ltd Palakkad Kerala · IN FEI 3013530281
Frequently asked questions
How many devices does Sanrea Healthcare Products Pvt, Ltd. have in the registry?
The registry currently lists 3 devices for Sanrea Healthcare Products Pvt, Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Sanrea Healthcare Products Pvt, Ltd.'s devices?
Among its 3 most recently registered devices, Sanrea Healthcare Products Pvt, Ltd. has devices listed in FDA 510(k) (3 devices).
What risk classes do Sanrea Healthcare Products Pvt, Ltd.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Sanrea Healthcare Products Pvt, Ltd.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Sanrea Healthcare Products Pvt, Ltd. in the registry?
The most recently registered devices listed for Sanrea Healthcare Products Pvt, Ltd. include STERILE NITRILE PATIENT EXAMINATION GLOVES, POWDERFREE, SANCARE STERILE LATEX EXAMINATION GLOVES (also marketed as GLOVTEK STERILE LATEX EXAMINATION GLOVES) and Sterile Latex Surgical Gloves, Powder Free.
Which FDA establishments are linked to Sanrea Healthcare Products Pvt, Ltd.?
1 FDA establishment is linked to Sanrea Healthcare Products Pvt, Ltd. in the registry; they are listed on the company page.