510(k) K223235
K223235 is an FDA 510(k) premarket notification submitted by Pt. Sintong Unigolden Glove for the device "Nitrile Examination Gloves Powder Free (Tested for use with Chemotherapy Drugs)". The FDA issued a decision of Substantially Equivalent on Oct 26, 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
- Oct 26, 2022
- Date Received
- Oct 13, 2022
- 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.