Cleared Traditional

K905527 - NEEDLESTICK PROTECTIVE GLOVE

K905527 is an FDA 510(k) clearance for NEEDLESTICK PROTECTIVE GLOVE, manufactured by Medev Corp.. The device is a Class 1 General Hospital device with product code LZC cleared through the Traditional 510(k) pathway after a 102-day FDA review.

K905527 · Medev Corp. · General Hospital
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Mar 1991
Decision
102d
Days
Class 1
Risk

K905527 is an FDA 510(k) clearance for the NEEDLESTICK PROTECTIVE GLOVE. Classified as Medical Glove, Specialty (product code LZC), Class I - General Controls.

Submitted by Medev Corp. (Hampton, US). The FDA issued a Cleared decision on March 22, 1991 after a review of 102 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 Medev Corp. devices

FDA 510(k) Submission Details - K905527

510(k) Number K905527 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 10, 1990
Decision Date March 22, 1991
Days to Decision 102 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
27d faster than avg
Panel avg: 129d · This submission: 102d
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 K905527.
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
ESP RADIATION REDUCTION EXAMINATION GLOVES
K891968 · Boston Scientific Corp · May 1989