510(k) K072228
K072228 is an FDA 510(k) premarket notification submitted by Pinnacle Co., Ltd. for the device "SYNTHETIC VINYL EXAMINATION GLOVE POWDER FREE (YELLOW/WHITE)". The FDA issued a decision of Substantially Equivalent on Feb 8, 2008. The device falls under product code LYZ (Vinyl Patient Examination Glove), a Class I device regulated under 21 CFR 880.6250. Pinnacle Co., Ltd. has 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Feb 8, 2008
- Date Received
- Aug 10, 2007
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Vinyl Patient Examination Glove
- Device Class
- Class I
- Regulation Number
- 880.6250
- Review Panel
- HO
- Submission Type
- 510(k)
A vinyl patient examination glove is a disposable device made of poly(vinyl chloride) 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.