510(k) K163146
K163146 is an FDA 510(k) premarket notification submitted by Hebei Hongsen Plastics Technology Co, Ltd. for the device "POWDER FREE Blue Nitrile GLOVES, Tested for Use with Chemotherapy Drugs". The FDA issued a decision of Substantially Equivalent on Feb 13, 2017. The device falls under product code LZC (Medical Glove, Specialty), a Class I device regulated under 21 CFR 880.6250. Hebei Hongsen Plastics Technology Co, Ltd. has 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Feb 13, 2017
- Date Received
- Nov 9, 2016
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Medical Glove, Specialty
- Device Class
- Class I
- Regulation Number
- 880.6250
- Review Panel
- HO
- Submission Type
- 510(k)
A disposable medical glove (examination or surgeons) is a device that may or may not bear a trace amount of residual powder and is intended to be worn on the hand or finger(s) for medical purposes to prevent contamination. In addition, these gloves may have specialty claims such as chemotherapy, etc.