510(k) K162491
K162491 is an FDA 510(k) premarket notification submitted by Hartalega Sdn Bhd for the device "Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (Blue)". The FDA issued a decision of Substantially Equivalent on Feb 8, 2017. The device falls under product code LZA (Polymer Patient Examination Glove), a Class I device regulated under 21 CFR 880.6250. Hartalega Sdn Bhd has 60 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Feb 8, 2017
- Date Received
- Sep 7, 2016
- 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.