Cleared Traditional

L3 (LEAD LATEX LYSNIG GLOVES) (K882437) - FDA 510(k) Clearance

Class I General Hospital device.

K882437 · The Branford Co. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1989
Decision
331d
Days
Class 1
Risk

K882437 is an FDA 510(k) clearance for the L3 (LEAD LATEX LYSNIG GLOVES). Classified as Medical Glove, Specialty (product code LZC), Class I - General Controls.

Submitted by The Branford Co. (Shelton, US). The FDA issued a Cleared decision on May 11, 1989 after a review of 331 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 The Branford Co. devices

Submission Details

510(k) Number K882437 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 14, 1988
Decision Date May 11, 1989
Days to Decision 331 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
202d slower than avg
Panel avg: 129d · This submission: 331d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 29
Devices cleared under the same product code (LZC) and FDA review panel - the closest regulatory comparables to K882437.
Non-Sterile Powder Free Blue Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs
K172864 · Maxter Glove Manufacturing Sdn Bhd · May 2018
Blue Non Sterile powder free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs
K173942 · Central Medicare Sdn Bhd · Mar 2018
ESP RADIATION REDUCTION EXAMINATION GLOVES
K891968 · Boston Scientific Corp · May 1989