510(k) K121811
K121811 is an FDA 510(k) premarket notification submitted by Shen Wei (Usa), Inc. for the device "POWDER FREE STERILE LATEX EXAM RADIATION ATTENUATION GLOVES". The FDA issued a decision of Substantially Equivalent on November 21, 2012. The device falls under product code LZC (Medical Glove, Specialty), a Class I device regulated under 21 CFR 880.6250. Shen Wei (Usa), Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 21, 2012
- Date Received
- June 20, 2012
- 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
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.