510(k) K173016
K173016 is an FDA 510(k) premarket notification submitted by Anhui Kindguard Medical Supplies Technology Co., Ltd. for the device "Kindguard Powder Free Vinyl Patient Examination Gloves, Light Yellow Color". The FDA issued a decision of Substantially Equivalent on Nov 15, 2017. The device falls under product code LYZ (Vinyl Patient Examination Glove), a Class I device regulated under 21 CFR 880.6250. Anhui Kindguard Medical Supplies Technology Co., Ltd. has 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Nov 15, 2017
- Date Received
- Sep 27, 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.