510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K910687Substantially Equivalent

Guardian Gel, Surgeon's Gloving Cream

Guardian Angel Products, Inc., Washington DC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K910687 is the FDA 510(k) clearance record for GUARDIAN GEL, SURGEON'S GLOVING CREAM, a class I device, cleared for Guardian Angel Products, Inc. on under FDA product code KGQ (Cream, Gloving, Surgeon'S). FDA records list 5 510(k) clearances for Guardian Angel Products, Inc., from to . As of , FDA records show no recalls naming K910687.

Clearance record

Decision date
Received
(234 days to decision)
Product code
KGQ Cream, Gloving, Surgeon'S
Regulation
21 CFR 878.4470
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Guardian Angel Products, Inc. Columbia Sq., Washington DC
Third party review
No

Clearances, product code KGQ

Trailing 12 months

FDA records hold no clearances under product code KGQ in the trailing twelve months.

FDA records show no clearances under product code KGQ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KGQ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260