510(k) K051318
K051318 is an FDA 510(k) premarket notification submitted by Platinum Glove Industries Sdn. Bhd. for the device "POWDER FREE NITRILE EXAMINATION GLOVES (WHITE, BLUE, AND PURPLE COLOR)". The FDA issued a decision of Substantially Equivalent on Jun 17, 2005. The device falls under product code LZA (Polymer Patient Examination Glove), a Class I device regulated under 21 CFR 880.6250. Platinum Glove Industries Sdn. Bhd. has 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jun 17, 2005
- Date Received
- May 20, 2005
- 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.