510(k) K190725
K190725 is an FDA 510(k) premarket notification submitted by Riverstone Resources Sdn Bhd for the device "Nitrile Examination Glove Sterile Tested for use with Chemotherapy Drugs Claim, White". The FDA issued a decision of Substantially Equivalent on Dec 17, 2019. The device falls under product code LZA (Polymer Patient Examination Glove), a Class I device regulated under 21 CFR 880.6250. Riverstone Resources Sdn Bhd has 14 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Dec 17, 2019
- Date Received
- Mar 20, 2019
- 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
- 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.