Cleared Traditional

K001613 - COMFIT CHEMO PLUS PLUS POWDER FREE NITR...

K001613 is the FDA 510(k) clearance for COMFIT CHEMO PLUS PLUS POWDER FREE NITR... by Wrp Asia Pacific Sdn. Bhd.. It is a Class 1 General Hospital device (product code LZA) cleared through the Traditional 510(k) pathway after a 181-day FDA review.

K001613 · Wrp Asia Pacific Sdn. Bhd. · General Hospital
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Nov 2000
Decision
181d
Days
Class 1
Risk

K001613 is an FDA 510(k) clearance for the COMFIT CHEMO PLUS PLUS POWDER FREE NITRILE EXAMINATION GLOVES (TESTED FOR USE.... Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Wrp Asia Pacific Sdn. Bhd. (Salak Tinggi, Sepang Selangor, MY). The FDA issued a Cleared decision on November 22, 2000 after a review of 181 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 Wrp Asia Pacific Sdn. Bhd. devices

Submission Details

510(k) Number K001613 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 25, 2000
Decision Date November 22, 2000
Days to Decision 181 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
52d slower than avg
Panel avg: 129d · This submission: 181d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LZA Polymer Patient Examination Glove
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6250
Definition A Nitrile (or Polymer) Patient Examination Glove Is A Disposable Device Made Of Nitrile Rubber Or Synthetic Polymers That May Or May Not Bear A Trace Amount Of Residual Powder, And Is Intended To Be Worn On The Hand For Medical Purposes To Provide A Barrier Against Potentially Infectious Materials And Other Contaminants.
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 - LZA Polymer Patient Examination Glove

All 583
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K001613.
NIRTRILE PATIENT EXAMINATION GLOVE (BLUE COLOR) POWDERED, NON STERILE
K002818 · Siam Sempermed Corp., Ltd. · Nov 2000
NITRILE PATIENT EXAMINATION GLOVE (GREEN COLOR) POWDERED, NON STERILE
K002819 · Siam Sempermed Corp., Ltd. · Nov 2000
COMFIT CHEMO PLUS POWDER FREE BLUE NITRILE EXAMINATION GLOVES, NON STERILE (TESTED FOR USE WITH CHEMOTHERAPY DRUG) LABEL
K002064 · Wrp Asia Pacific Sdn. Bhd. · Nov 2000
MEDLINE ALOE TOUCH STERILE NITRILE EXAMINATION GLOVES WITH ALOE VERA
K003353 · Medline Industries, Inc. · Nov 2000
POWDER-FREE NITRILE EXAMINATION GLOVE (TESTED FOR USE WITH CHEMOTHERAPY DRUGS)
K991422 · Shen Wei (Usa), Inc. · May 2000
NITRILE PATIENT EXAMINATION GLOVE (BLUE COLOR) POWDER FREE, NON STERILE
K000323 · Siam Sempermed Corp., Ltd. · Apr 2000