510(k) K230217
K230217 is an FDA 510(k) premarket notification submitted by Grand Work Plastic Products Co., Ltd. for the device "Sterile Polyisoprene Powder Free Surgical Glove, Tested for Use with Chemotherapy Drugs". The FDA issued a decision of Substantially Equivalent on May 13, 2023. The device falls under product code KGO (Surgeon'S Gloves), a Class I device regulated under 21 CFR 878.4460. Grand Work Plastic Products Co., Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 13, 2023
- Date Received
- January 26, 2023
- 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.