510(k) K211810
K211810 is an FDA 510(k) premarket notification submitted by Pt. Shamrock Manufacturing Corpora for the device "Shamrock Powder Free Blue Nitrile Examination Gloves (Tested for use with Chemotherapy Drugs and Fentanyl)". The FDA issued a decision of Substantially Equivalent on May 23, 2022. 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
- May 23, 2022
- Date Received
- Jun 11, 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.