510(k) K163017
K163017 is an FDA 510(k) premarket notification submitted by Gmp Medicare Sdn. Bhd. for the device "Nitrile Blue Powder Free Examination Gloves with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs". The FDA issued a decision of Substantially Equivalent on March 22, 2017. The device falls under product code LZC (Medical Glove, Specialty), a Class I device regulated under 21 CFR 880.6250. Gmp Medicare Sdn. Bhd. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 22, 2017
- Date Received
- October 28, 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
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.