510(k) K150103
K150103 is an FDA 510(k) premarket notification submitted by Hartalega Sdn Bhd for the device "Nitrile Powder Free Examination Gloves (Orange) Tested For Use With Chemotherapy Drugs". The FDA issued a decision of Substantially Equivalent on Apr 23, 2015. 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
- Apr 23, 2015
- Date Received
- Jan 20, 2015
- 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.