Cleared Traditional

K091643 - POWDER FREE LATEX EXAMINATION GLOVES

K091643 is an FDA 510(k) clearance for POWDER FREE LATEX EXAMINATION GLOVES, manufactured by Gx Corporation Sdn Bhd. The device is a Class 1 General Hospital device with product code LZC cleared through the Traditional 510(k) pathway after a 151-day FDA review.

K091643 · Gx Corporation Sdn Bhd · General Hospital
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Nov 2009
Decision
151d
Days
Class 1
Risk

K091643 is an FDA 510(k) clearance for the POWDER FREE LATEX EXAMINATION GLOVES, BLUE, TESTED FOR USE WITH CHEMOTHERAPY .... Classified as Medical Glove, Specialty (product code LZC), Class I - General Controls.

Submitted by Gx Corporation Sdn Bhd (Klang, Selang Darul Ehsan, MY). The FDA issued a Cleared decision on November 2, 2009 after a review of 151 days - an extended review 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: 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 Gx Corporation Sdn Bhd devices

FDA 510(k) Submission Details - K091643

510(k) Number K091643 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 04, 2009
Decision Date November 02, 2009
Days to Decision 151 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
22d slower than avg
Panel avg: 129d · This submission: 151d
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 K091643.
POWDER FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE COLORED NON-STERILE (LOW DERAMATITIS POTENTIAL AND CHEMOTHERAPY DRUG
K102790 · Perusahaan Getah Asas Sdn. Bhd. · Nov 2010
NON-STERILE POWDER-FREE BLUE NITRILE EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGS
K101822 · Sgmp Co., Ltd. · Nov 2010
PEARLESCENT POWDER FREE NITRILE EXAMINATION GLOVE WITH ALOE VERA (YELLOW, RED, GREEN, BLACK, BLUE)
K101436 · Shen Wei (Usa), Inc. · Nov 2010
POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGS
K083408 · Wrp Asia Pacific Sdn. Bhd. · Jul 2009
POWDER FREE LATEX PATIENT EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGS WITH A PROTEIN CONTENT LABEL CLAIM
K083410 · Wrp Asia Pacific Sdn. Bhd. · Jul 2009
POWDER FREE BLUE LATEX PATIENT EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGS WITH A PROTEIN CONTENT LABEL
K083409 · Wrp Asia Pacific Sdn. Bhd. · Jul 2009