510(k) K171898
K171898 is an FDA 510(k) premarket notification submitted by Better Care Plastic Technology Co., Ltd. for the device "Sterile Polyisoprene Powder Free Surgical Gloves, Tested for Use With Chemotherapy Drugs". The FDA issued a decision of Substantially Equivalent on August 18, 2017. The device falls under product code KGO (Surgeon'S Gloves), a Class I device regulated under 21 CFR 878.4460. Better Care Plastic Technology Co., Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 18, 2017
- Date Received
- June 26, 2017
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Surgeon'S Gloves
- Device Class
- Class I
- Regulation Number
- 878.4460
- Review Panel
- HO
- Submission Type
A surgeon's glove is a disposable device made of natural rubber latex or synthetic polymers that may or may not bear powder to facilitate donning, and it is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants.