510(k) K172867
K172867 is an FDA 510(k) premarket notification submitted by Gmp Medicare Sdn Bhd (F25) for the device "Nitrile Examination Powder Free Glove, Black, Nitrile Examination Powder Free Glove, Orange". The FDA issued a decision of Substantially Equivalent on May 10, 2018. The device falls under product code LZA (Polymer Patient Examination Glove), a Class I device regulated under 21 CFR 880.6250. Gmp Medicare Sdn Bhd (F25) has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 10, 2018
- Date Received
- September 20, 2017
- 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
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.