Cleared Special

K023517 - DERMAGRIP-P POWDER FREE PINK NITRILE EX...

K023517 is the FDA 510(k) clearance for DERMAGRIP-P POWDER FREE PINK NITRILE EX... by Wrp Asia Pacific Sdn. Bhd.. It is a Class 1 General Hospital device (product code LZA) cleared through the Special 510(k) pathway after a 45-day FDA review.

K023517 · Wrp Asia Pacific Sdn. Bhd. · General Hospital
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Dec 2002
Decision
45d
Days
Class 1
Risk

K023517 is an FDA 510(k) clearance for the DERMAGRIP-P POWDER FREE PINK NITRILE EXAMINATION GLOVES, NON-STERILE. 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 December 2, 2002 after a review of 45 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Wrp Asia Pacific Sdn. Bhd. devices

Submission Details

510(k) Number K023517 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 18, 2002
Decision Date December 02, 2002
Days to Decision 45 days
Submission Type Special
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
84d faster than avg
Panel avg: 129d · This submission: 45d
Pathway characteristics
Modification to existing cleared device.

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 K023517.
FREEFORM BLUE POWDER-FREE NITRILE EXAMINATION GLOVES
K041391 · Hartalega Sdn Bhd · Jul 2004
POWDER FREE NITRILE EXAMINATION GLOVES (TESTED FOR USE WITH CHEMOTHERAPY DRUGS)
K040841 · Medline Industries, Inc. · Jul 2004
POWDER-FREE NITRILE EXAMINATION GLOVES, BLUE COLOR (TESTED FOR USE WITH CHEMOTHERAPY DRUGS)
K032024 · Shen Wei (Usa), Inc. · Oct 2003
FREEFORM BLUE POWDERFREE NITRILE EXAMINATION GLOVES
K022671 · Hartalega Sdn Bhd · Nov 2002
NITRILE POWDER-FREE EXAMINATION GLOVES
K022765 · Allegiance Healthcare Corp. · Oct 2002
NITRILE POWDER-FREE EXAMINATION GLOVES
K023170 · Allegiance Healthcare Corp. · Oct 2002