Guardian Gel, Surgeon's Gloving Cream

FDA 510(k) K910687 · Guardian Angel Products, Inc.

Substantially Equivalent

510(k) numberK910687

Submission

Device name
Guardian Gel, Surgeon's Gloving Cream
Applicant
Guardian Angel Products, Inc.
Washington, DC, US
Received
February 19, 1991
Decision date
October 11, 1991
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
KGQ – Cream, Gloving, Surgeon'S
Device class
Class I (low risk)
Regulation
21 CFR 878.4470
Specialty
General, Plastic Surgery

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Questions and answers

When was Guardian Gel, Surgeon's Gloving Cream cleared by the FDA?

Guardian Gel, Surgeon's Gloving Cream (K910687) received a 510(k) decision of Substantially Equivalent on October 11, 1991, 234 days after the submission was received.

What is the product code of K910687?

The FDA product code is KGQ – Cream, Gloving, Surgeon'S, a Class I (low risk) device regulated under 21 CFR 878.4470.