Cleared Traditional

K032374 - POWDER-FREE NITRILE PATIENT CHEMOTHERAPY EXAMINATION GLOVE, BLUE COLORED

K032374 is an FDA 510(k) clearance for POWDER-FREE NITRILE PATIENT CHEMOTHERAP..., manufactured by Perusahaan Getah Asas Sdn. Bhd.. The device is a Class 1 General Hospital device with product code LZC cleared through the Traditional 510(k) pathway after a 82-day FDA review.

K032374 · Perusahaan Getah Asas Sdn. Bhd. · General Hospital
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Optimized for regulatory review, auditing and printing
Oct 2003
Decision
82d
Days
Class 1
Risk

K032374 is an FDA 510(k) clearance for the POWDER-FREE NITRILE PATIENT CHEMOTHERAPY EXAMINATION GLOVE, BLUE COLORED. Classified as Medical Glove, Specialty (product code LZC), Class I - General Controls.

Submitted by Perusahaan Getah Asas Sdn. Bhd. (Gambrills, US). The FDA issued a Cleared decision on October 22, 2003 after a review of 82 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 Perusahaan Getah Asas Sdn. Bhd. devices

FDA 510(k) Submission Details - K032374

510(k) Number K032374 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 2003
Decision Date October 22, 2003
Days to Decision 82 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
47d faster than avg
Panel avg: 129d · This submission: 82d
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 63
Devices cleared under the same product code (LZC) and FDA review panel - the closest regulatory comparables to K032374.
POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, BLUE COLORED NON-STERILE
K042805 · Perusahaan Getah Asas Sdn. Bhd. · Dec 2004
LATEX POWDER-FREE EXAMINATION GLOVES WITH COATING
K033789 · Cardinalhealth · May 2004
NITRILE POWDER-FREE EXAMINATION GLOVES WITH LOTION COATING AND USE FOR CHEMOTHERAPY
K032444 · Cardinalhealth · Nov 2003
STERILE NITRILE POWDER-FREE EXAMINATION GLOVES
K010211 · Allegiance Healthcare Corp. · Feb 2001
ABSOGEL CHEMOTHERAPHY GLOVES
K990677 · Ampri Rubberware Industries Sdn Bhd · Nov 1999
SAFESKIN PURPLE POWDER-FREE NITRILE EXAMINATION GLOVES FOR USE WITH CHEMOTHERAPEUTIC DRUGS LABELING CLAIM
K992162 · Safeskin Corp. · Aug 1999