510(k) K143247
K143247 is an FDA 510(k) premarket notification submitted by Central Medicare Sdn Bhd for the device "Powder Free Nitrile Examination Gloves, Nonsterile,(Blue,Black, and White Colored)". The FDA issued a decision of Substantially Equivalent on January 22, 2015. The device falls under product code LZA (Polymer Patient Examination Glove), a Class I device regulated under 21 CFR 880.6250. Central Medicare Sdn Bhd has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 22, 2015
- Date Received
- November 12, 2014
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Polymer Patient Examination Glove
- Device Class
- Class I
- Regulation Number
- 880.6250
- Review Panel
- HO
- Submission Type
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.