510(k) K910687

GUARDIAN GEL, SURGEON'S GLOVING CREAM by Guardian Angel Products, Inc. — Product Code KGQ

K910687 is an FDA 510(k) premarket notification submitted by Guardian Angel Products, Inc. for the device "GUARDIAN GEL, SURGEON'S GLOVING CREAM". The FDA issued a decision of Substantially Equivalent on October 11, 1991. The device falls under product code KGQ (Cream, Gloving, Surgeon'S), a Class I device regulated under 21 CFR 878.4470. Guardian Angel Products, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 11, 1991
Date Received
February 19, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cream, Gloving, Surgeon'S
Device Class
Class I
Regulation Number
878.4470
Review Panel
HO
Submission Type