510(k) K162186
K162186 is an FDA 510(k) premarket notification submitted by Brightway Holdings Sdn. Bhd. for the device "BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES 12, POWDER FREE, [STERLING/GREY] WITH CHEMOTHERAPY CLAIM". The FDA issued a decision of Substantially Equivalent on Mar 31, 2017. The device falls under product code LZC (Medical Glove, Specialty), a Class I device regulated under 21 CFR 880.6250. Brightway Holdings Sdn. Bhd. has 23 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Mar 31, 2017
- Date Received
- Aug 4, 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.