510(k) K170612
K170612 is an FDA 510(k) premarket notification submitted by Primus Gloves Pvt Limited for the device "STERILE VINYL EXAMINATION GLOVES, Powder Free". The FDA issued a decision of Substantially Equivalent on Oct 23, 2017. The device falls under product code LYZ (Vinyl Patient Examination Glove), a Class I device regulated under 21 CFR 880.6250. Primus Gloves Pvt Limited has 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 23, 2017
- Date Received
- Mar 1, 2017
- 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.