510(k) K190860
K190860 is an FDA 510(k) premarket notification submitted by Ever Growth (Vietnam) Co. , Ltd. for the device "Disposable Powder Free Nitrile Examination Glove, Tested For Use With Chemotherapy Drugs, White color, Disposable Powder Free Nitrile Examination Glove, Tested For Use With Chemotherapy Drugs, Orange color". The FDA issued a decision of Substantially Equivalent on Dec 23, 2019. The device falls under product code LZA (Polymer Patient Examination Glove), a Class I device regulated under 21 CFR 880.6250. Ever Growth (Vietnam) Co. , Ltd. has 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Dec 23, 2019
- Date Received
- Apr 2, 2019
- Clearance Type
- Abbreviated
- 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
- 510(k)
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.