Brightway Gloves Pvt., Ltd.
IndiaFDA 510(k) applicant, unverified
- Devices
- 4
What Brightway Gloves Pvt., Ltd. makes
Brightway Gloves Pvt., Ltd. manufactures latex surgical and examination gloves, available in both powdered and powder-free formulations. These products are designed for single-use in medical, dental, and laboratory settings to maintain sterility and reduce contamination risk during procedures.
The company’s latex gloves are classified as Class I medical devices under FDA regulations and are listed via the 510(k) pathway. These products are intended for use in the United States, where compliance with FDA requirements is mandatory for distribution.
Catalogue
Latex Surgeons Glove (Powder Free) Ref K014283
510(k) 510(k)Latex Surgeons Glove (Powdered) Ref K014278
510(k) 510(k)Latex Examination Gloves (Powder Free) Ref K014279
510(k) 510(k)Latex Examination Glove (Powdered) Ref K014280
510(k) 510(k)
Frequently asked questions
How many devices does Brightway Gloves Pvt., Ltd. have in the registry?
The registry currently lists 4 devices for Brightway Gloves Pvt., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Brightway Gloves Pvt., Ltd.'s devices?
Among its 4 most recently registered devices, Brightway Gloves Pvt., Ltd. has devices listed in FDA 510(k) (4 devices).
What risk classes do Brightway Gloves Pvt., Ltd.'s devices fall under?
Among its 4 most recently registered devices, the classes recorded for Brightway Gloves Pvt., Ltd.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Brightway Gloves Pvt., Ltd. in the registry?
The most recently registered devices listed for Brightway Gloves Pvt., Ltd. include LATEX SURGEONS GLOVE (POWDER FREE), LATEX SURGEONS GLOVE (POWDERED), LATEX EXAMINATION GLOVES (POWDER FREE) and LATEX EXAMINATION GLOVE (POWDERED).