510(k) K212613
K212613 is an FDA 510(k) premarket notification submitted by Koon Seng Sdn Bhd for the device "Powder Free Nitrile Examination Gloves, Non-sterile,Tested For Use with Chemotherapy Drugs and Opioid Fentanyl Citrate (Blue)". The FDA issued a decision of Substantially Equivalent on Dec 21, 2021. The device falls under product code LZA (Polymer Patient Examination Glove), a Class I device regulated under 21 CFR 880.6250. Koon Seng Sdn Bhd has 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Dec 21, 2021
- Date Received
- Aug 18, 2021
- 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.