510(k) K201774
K201774 is an FDA 510(k) premarket notification submitted by Pt. Medisafe Technologies for the device "Polychloroprene Powder Free Sterile Surgical Gloves, Low Dermatitis Potential and Tested for Use with Chemotherapy Drugs". The FDA issued a decision of Substantially Equivalent on Sep 16, 2020. The device falls under product code KGO (Surgeon'S Gloves), a Class I device regulated under 21 CFR 878.4460. Pt. Medisafe Technologies has 18 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Sep 16, 2020
- Date Received
- Jun 29, 2020
- 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
- 510(k)
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.