510(k) K102089
K102089 is an FDA 510(k) premarket notification submitted by Grand Work Plastic Products Co., Ltd. for the device "GRAND WORK PLASTIC PRODUCTS CO., LTD. POWDER FREE VINYL PATIENT EXAMINATION GLOVES". The FDA issued a decision of Substantially Equivalent on October 6, 2010. The device falls under product code LYZ (Vinyl Patient Examination Glove), a Class I device regulated under 21 CFR 880.6250. Grand Work Plastic Products Co., Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 6, 2010
- Date Received
- August 5, 2010
- 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
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.