510(k) Report

510(k) · Cleared

Cleared

Guardian Gel, Surgeon's Gloving Cream

K910687510(k) TraditionalCleared Oct 11, 1991234-day reviewClass I21 CFR 878.4470

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Guardian Angel Products, Inc. · KGQ Cream, Gloving, Surgeon'S

Cleared on Oct 11, 1991 after a 234-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Oct 11, 1991
Review
234 days
Class
Class I
Product code
KGQ
Recalls
None
Predicates
0

FDA has not posted a summary or statement for it, so its predicates are not known.

FIG. 1 — Lineage of K910687Source: FDA 510(k) database · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

How does its category compare?

All KGQ devices

KGQ Cream, Gloving, Surgeon'S: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KGQ

FDA has decided no KGQ device since 2007.

Median 510(k) review, days · KGQ

Too few KGQ 510(k)s in any year since 2007 to give a median.

Recalls per year · KGQ

No recall names KGQ since 2007.

Adverse event reports per year · KGQ

No MAUDE report names KGQ since 2007.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

More from Guardian Angel Products, Inc.

5 FDA decisions under this applicant name. See the company

  • K030547Modification to Zap Guard Defibrillator Test ProbeGuardian Angel Products, Inc. · 2003
  • K923840Needle-GrabberGuardian Angel Products, Inc. · 1993
  • K923835The Eleventh FingerGuardian Angel Products, Inc. · 1993
  • K896985Zap-GuardGuardian Angel Products, Inc. · 1990

https://510kreport.com/device/K910687 · printed Nov 6, 2026

Cite this page

510(k) Report. “K910687: Guardian Gel, Surgeon's Gloving Cream.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K910687

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Record history
  • FDA decision record loaded May 2, 2026
  • Page last updated Nov 3, 2026