Cleared Traditional

K011482 - DERMASAFE CHEMO PLUS POWDER FREE NEOPRE...

K011482 is the FDA 510(k) clearance for DERMASAFE CHEMO PLUS POWDER FREE NEOPRE... 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 56-day FDA review.

K011482 · Wrp Asia Pacific Sdn. Bhd. · General Hospital
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Optimized for regulatory review, auditing and printing
Jul 2001
Decision
56d
Days
Class 1
Risk

K011482 is an FDA 510(k) clearance for the DERMASAFE CHEMO PLUS POWDER FREE NEOPRENE EXAMINATION GLOVE (TESTED FOR USE W.... Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Wrp Asia Pacific Sdn. Bhd. (Sepang, MY). The FDA issued a Cleared decision on July 9, 2001 after a review of 56 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 Wrp Asia Pacific Sdn. Bhd. devices

Submission Details

510(k) Number K011482 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 14, 2001
Decision Date July 09, 2001
Days to Decision 56 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
73d faster than avg
Panel avg: 129d · This submission: 56d
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 K011482.
NITRILE PATIENT EXAMINATION GLOVE POWDER-FREE (BLUE COLOR) TESTED FOR USE WITH CHEMOTHERAPY DRUGS
K021220 · Siam Sempermed Corp., Ltd. · Jun 2002
POWDER-FREE BUTADIENE COPOLYMER EXAM GLOVES WITH ALOE, VITAMINS E PH5.5
K011961 · Shen Wei (Usa), Inc. · Sep 2001
POWDER FREE NEOPRENE EXAMINATION GLOVES, NON STERILE
K012048 · Wrp Asia Pacific Sdn. Bhd. · Aug 2001
SAFESKIN NEON NITRILE - POWDER FREE NEON EXAM GLOVE
K011713 · Kimberly-Clark Corp. · Jul 2001
POWDER-FREE NITRILE EXAMINATION GLOVES, WHITE
K010110 · Shen Wei (Usa), Inc. · Apr 2001
POWDER-FREE NITRILE EXAMINATION GLOVES WITH ALOE VERA, GREEN (TESTED FOR USE WITH CHEMOTHERAPY DRUGS)
K010097 · Shen Wei (Usa), Inc. · Mar 2001