510(k) K234097
K234097 is an FDA 510(k) premarket notification submitted by Ever Growth (Vietnam) Corporation Limited for the device "Disposable Powder Free Nitrile Examination Glove, Natural Blue Color, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate". The FDA issued a decision of Substantially Equivalent on March 27, 2024. The device falls under product code LZA (Polymer Patient Examination Glove), a Class I device regulated under 21 CFR 880.6250.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 27, 2024
- Date Received
- December 26, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Polymer Patient Examination Glove
- Device Class
- Class I
- Regulation Number
- 880.6250
- Review Panel
- HO
- Submission Type
A nitrile (or polymer) patient examination glove is a disposable device made of nitrile rubber or synthetic polymers that may or may not bear a trace amount of residual powder, and is intended to be worn on the hand for medical purposes to provide a barrier against potentially infectious materials and other contaminants.