Cleared Traditional

K945577 - GUARDIAN II GLOVE

K945577 is an FDA 510(k) clearance for GUARDIAN II GLOVE, manufactured by Guardian Group, Inc.. The device is a Class 1 General Hospital device with product code LZC cleared through the Traditional 510(k) pathway after a 45-day FDA review.

K945577 · Guardian Group, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1994
Decision
45d
Days
Class 1
Risk

K945577 is an FDA 510(k) clearance for the GUARDIAN II GLOVE. Classified as Medical Glove, Specialty (product code LZC), Class I - General Controls.

Submitted by Guardian Group, Inc. (San Diego, US). The FDA issued a Cleared decision on December 29, 1994 after a review of 45 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6250 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Guardian Group, Inc. devices

FDA 510(k) Submission Details - K945577

510(k) Number K945577 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 14, 1994
Decision Date December 29, 1994
Days to Decision 45 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
84d faster than avg
Panel avg: 129d · This submission: 45d
Pathway characteristics
Predicate-based equivalence.

LZC Device Classification - Class 1, General Controls

Product Code LZC Medical Glove, Specialty
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6250
Definition A Disposable Medical Glove (examination Or Surgeon’s) Is A Device That May Or May Not Bear A Trace Amount Of Residual Powder And Is Intended To Be Worn On The Hand Or Finger(s) For Medical Purposes To Prevent Contamination. In Addition, These Gloves May Have Specialty Claims Such As Chemotherapy, Etc.
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - LZC Medical Glove, Specialty

All 69
Devices cleared under the same product code (LZC) and FDA review panel - the closest regulatory comparables to K945577.
SAFESKIN PURPLE POWDER-FREE NITRILE EXAMINATION GLOVES FOR USE WITH CHEMOTHERAPEUTIC DRUGS LABELING CLAIM
K992162 · Safeskin Corp. · Aug 1999
PROGUARD, RR-1, RR-2
K982832 · Emerson & Co. Srl · Dec 1998
NITRILE GLOVES
K970135 · Sage Products, Inc. · Aug 1997
FLUORO-SHIELD RADIATION REDUCTION GLOVES
K920620 · Acufex Microsurgical, Inc. · Jun 1993
FLOUROSHIELD RADIATION REDUCTION GLOVE
K893093 · Acufex Microsurgical, Inc. · Feb 1990
L(3), LYSNIG LEAD LATEX RADIATION GLOVE(R)
K896076 · Advance Medical Designs, Inc. · Jan 1990