Cleared Traditional

K982832 - PROGUARD

K982832 is an FDA 510(k) clearance for PROGUARD, manufactured by Emerson & Co. Srl. The device is a Class 1 General Hospital device with product code LZC cleared through the Traditional 510(k) pathway after a 133-day FDA review.

K982832 · Emerson & Co. Srl · General Hospital
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Dec 1998
Decision
133d
Days
Class 1
Risk

K982832 is an FDA 510(k) clearance for the PROGUARD, RR-1, RR-2. Classified as Medical Glove, Specialty (product code LZC), Class I - General Controls.

Submitted by Emerson & Co. Srl (Genoa, IT). The FDA issued a Cleared decision on December 23, 1998 after a review of 133 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Emerson & Co. Srl devices

FDA 510(k) Submission Details - K982832

510(k) Number K982832 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 12, 1998
Decision Date December 23, 1998
Days to Decision 133 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
4d slower than avg
Panel avg: 129d · This submission: 133d
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 51
Devices cleared under the same product code (LZC) and FDA review panel - the closest regulatory comparables to K982832.
POWDER-FREE NITRILE PATIENT CHEMOTHERAPY EXAMINATION GLOVE, BLUE COLORED
K032374 · Perusahaan Getah Asas Sdn. Bhd. · Oct 2003
STERILE NITRILE POWDER-FREE EXAMINATION GLOVES
K010211 · Allegiance Healthcare Corp. · Feb 2001
SAFESKIN PURPLE POWDER-FREE NITRILE EXAMINATION GLOVES FOR USE WITH CHEMOTHERAPEUTIC DRUGS LABELING CLAIM
K992162 · Safeskin Corp. · Aug 1999
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