Cleared Traditional

K081971 - BIOCLEAN CHEMO ULTIMATE POWDER FREE POLYCHLOROPRENE EXAMINATION GLOVES

K081971 is an FDA 510(k) clearance for BIOCLEAN CHEMO ULTIMATE POWDER FREE POL..., manufactured by Nitritex (M) Sdn. Bhd.. The device is a Class 1 General Hospital device with product code LZC cleared through the Traditional 510(k) pathway after a 166-day FDA review.

K081971 · Nitritex (M) Sdn. Bhd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2008
Decision
166d
Days
Class 1
Risk

K081971 is an FDA 510(k) clearance for the BIOCLEAN CHEMO ULTIMATE POWDER FREE POLYCHLOROPRENE EXAMINATION GLOVES. Classified as Medical Glove, Specialty (product code LZC), Class I - General Controls.

Submitted by Nitritex (M) Sdn. Bhd. (Kuala Langat, Selangor De, MY). The FDA issued a Cleared decision on December 23, 2008 after a review of 166 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 Nitritex (M) Sdn. Bhd. devices

FDA 510(k) Submission Details - K081971

510(k) Number K081971 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 10, 2008
Decision Date December 23, 2008
Days to Decision 166 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
37d slower than avg
Panel avg: 129d · This submission: 166d
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 54
Devices cleared under the same product code (LZC) and FDA review panel - the closest regulatory comparables to K081971.
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
POWDER FREE NITRILE EXAMINATION GLOVES, STERILE WITH CHEMOTHERAPY CLAIM
K083305 · Wrp Asia Pacific Sdn. Bhd. · Jun 2009
KIMBERLY-CLARK STERLING NITRILE & NITRILE-XTRA POWDER-FREE EXAM GLOVES WITH CHEMOTHERAPY DRUG USE CLAIM
K081089 · Kimberly-Clark Corp. · Jul 2008
POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE, WHITE (NON-COLORED) AND BLUE COLORED
K062764 · Kossan Latex Industries(M)Sdn Bhd · Feb 2007
POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, BLUE COLORED NON-STERILE
K042805 · Perusahaan Getah Asas Sdn. Bhd. · Dec 2004