510(k) K161961
K161961 is an FDA 510(k) premarket notification submitted by Ug Global Resources Sdn. Bhd. for the device "UniTex Non-Sterile, Powder-Free, Latex Examination Glove". The FDA issued a decision of Substantially Equivalent on May 11, 2017. The device falls under product code LYY (Latex Patient Examination Glove), a Class I device regulated under 21 CFR 880.6250. Ug Global Resources Sdn. Bhd. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 11, 2017
- Date Received
- July 18, 2016
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Latex Patient Examination Glove
- Device Class
- Class I
- Regulation Number
- 880.6250
- Review Panel
- HO
- Submission Type
A latex patient examination glove is a disposable device made of natural rubber latex 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.