510(k) K163126
K163126 is an FDA 510(k) premarket notification submitted by Blue Sail Medical Co.,Ltd for the device "Powder Free Nitrile Examination Gloves (Blue, White, Black, Violet Blue, Cobalt blue)". The FDA issued a decision of Substantially Equivalent on Feb 22, 2017. The device falls under product code LZA (Polymer Patient Examination Glove), a Class I device regulated under 21 CFR 880.6250. Blue Sail Medical Co.,Ltd has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Feb 22, 2017
- Date Received
- Nov 8, 2016
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Polymer Patient Examination Glove
- Device Class
- Class I
- Regulation Number
- 880.6250
- Review Panel
- HO
- Submission Type
- 510(k)
A nitrile (or polymer) patient examination glove is a disposable device made of nitrile rubber or synthetic polymers that may or may not bear a trace amount of residual powder, and is intended to be worn on the hand for medical purposes to provide a barrier against potentially infectious materials and other contaminants.