510(k) K220401
K220401 is an FDA 510(k) premarket notification submitted by Riverstone Resources Sdn Bhd for the device "Pink Powder Free Nitrile Examination Glove With Bubblegum Scented, Chemotherapy Drugs And Fentanyl Test Claim". The FDA issued a decision of Substantially Equivalent on Apr 9, 2022. 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
- Apr 9, 2022
- Date Received
- Feb 11, 2022
- 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.