510(k) K173766
K173766 is an FDA 510(k) premarket notification submitted by Shen Wei USA, Inc. for the device "PF Nitrile Exam Glove with pH coating, Black-Gray Color, Tested for Use with Chemo Drugs". The FDA issued a decision of Substantially Equivalent on Jul 8, 2018. 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 17 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jul 8, 2018
- Date Received
- Dec 11, 2017
- 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.