510(k) K101596
K101596 is an FDA 510(k) premarket notification submitted by Kimberly-Clark for the device "KIMBERLY-CLARK PURPLE NITRILE POWDER-FREE EXAM GLOVE (CHEMOTHERAPY GLOVE) AND KIMBERLY-CLARK PURPLE NITRILE XTRA POWDER-". The FDA issued a decision of Substantially Equivalent on July 21, 2010. The device falls under product code LZC (Medical Glove, Specialty), a Class I device regulated under 21 CFR 880.6250. Kimberly-Clark has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 21, 2010
- Date Received
- June 8, 2010
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Medical Glove, Specialty
- Device Class
- Class I
- Regulation Number
- 880.6250
- Review Panel
- HO
- Submission Type
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.