510(k) K182612
K182612 is an FDA 510(k) premarket notification submitted by Zibo Yahao Supplies Co., Ltd. for the device "Powder Free Nitrile Examination Gloves (Cobalt Blue, Black, Blue and Violet Blue)". The FDA issued a decision of Substantially Equivalent on May 10, 2019. The device falls under product code LZA (Polymer Patient Examination Glove), a Class I device regulated under 21 CFR 880.6250.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 10, 2019
- Date Received
- Sep 21, 2018
- 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.