FDA product code KGQ: Cream, Gloving, Surgeon'S

KGQ is the FDA product code for cream, gloving, surgeon's. It is a Class I device, regulated under 21 CFR 878.4470 and reviewed by the General Hospital panel. FDA has cleared 1 510(k) submission under KGQ. The average 510(k) review took 234 days (median 234).

Classification

Compare with all 510(k) review times · Search every KGQ clearance

Top KGQ applicants

Most recent KGQ clearances

Recalls for KGQ devices

openFDA lists no recalls for product code KGQ.

Frequently asked questions

What is FDA product code KGQ?

KGQ is the FDA product code for cream, gloving, surgeon's. It is a Class I device, regulated under 21 CFR 878.4470 and reviewed by the General Hospital panel.

What device class is KGQ?

Class I, regulation 21 CFR 878.4470. Typical premarket route: 510(k) exempt.

How long does a 510(k) take for product code KGQ?

Across 1 cleared submissions the average was 234 days from receipt to decision (median 234).

Which companies have the most KGQ clearances?

Guardian Angel Products, Inc. (1).

Next steps

• Run an FDA pathway report with predicate devices for product code KGQ
• Run a recall and safety report across every KGQ manufacturer
• Watch product code KGQ for new clearances and recalls

Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.

All General Hospital product codes · FDA product code lookup · 510(k) database search · 510(k) review times