Cleared Traditional

SCINITREX (POWDER FREE NITRILE EXAMINATION GLOVES) (K952051) - FDA 510(k) Clearance

Class I General Hospital device.

K952051 · Wembley Rubber Products (M) Sdn Bhd · General Hospital
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Dec 1995
Decision
228d
Days
Class 1
Risk

K952051 is an FDA 510(k) clearance for the SCINITREX (POWDER FREE NITRILE EXAMINATION GLOVES). Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Wembley Rubber Products (M) Sdn Bhd (Salak Tinggi, Sepang Selangor, MY). The FDA issued a Cleared decision on December 15, 1995 after a review of 228 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 Wembley Rubber Products (M) Sdn Bhd devices

Submission Details

510(k) Number K952051 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 01, 1995
Decision Date December 15, 1995
Days to Decision 228 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
99d slower than avg
Panel avg: 129d · This submission: 228d
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 497
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K952051.
POWDER FREE NITRILE EXAMINATION GLOVES (TESTED FOR USE WITH CHEMOTHERAPY DRUGS)
K040841 · Medline Industries, Inc. · Jul 2004
SAFESKIN NEON NITRILE - POWDER FREE NEON EXAM GLOVE
K011713 · Kimberly-Clark Corp. · Jul 2001
MEDLINE ALOE TOUCH STERILE NITRILE EXAMINATION GLOVES WITH ALOE VERA
K003353 · Medline Industries, Inc. · Nov 2000
DISPOSABLE POLY GLOVES
K841676 · Abco Dealers, Inc. · May 1984