Cleared Traditional

K952155 - SCINITREX BLUE POWDERED NITRILE EXAMINA...

K952155 is an FDA 510(k) clearance for SCINITREX BLUE POWDERED NITRILE EXAMINA..., manufactured by Wembley Rubber Products (M) Sdn Bhd. The device is a Class 1 General Hospital device with product code LZA cleared through the Traditional 510(k) pathway after a 217-day FDA review.

K952155 · Wembley Rubber Products (M) Sdn Bhd · General Hospital
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Optimized for regulatory review, auditing and printing
Dec 1995
Decision
217d
Days
Class 1
Risk

K952155 is an FDA 510(k) clearance for the SCINITREX BLUE POWDERED 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 11, 1995 after a review of 217 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

FDA 510(k) Submission Details - K952155

510(k) Number K952155 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 08, 1995
Decision Date December 11, 1995
Days to Decision 217 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
88d slower than avg
Panel avg: 129d · This submission: 217d
Pathway characteristics
Predicate-based equivalence.

LZA Device Classification - Class 1, General Controls

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 724
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K952155.
SCINITREX (POWDER FREE GREEN NITRILE EXAMINATION GLOVES
K951938 · Wembley Rubber Products (M) Sdn Bhd · Dec 1995
SCINITREX (POWDER FREE NITRILE EXAMINATION GLOVES)
K952051 · Wembley Rubber Products (M) Sdn Bhd · Dec 1995
SCINITREX POWER FREE BLUE NITRILE EXAMINATION GLOVES
K952154 · Wembley Rubber Products (M) Sdn Bhd · Dec 1995
SCINITREX (GREEN POWDERED NITRILE EXAMINATION GLOVES)
K951921 · Wembley Rubber Products (M) Sdn Bhd · Oct 1995
SCINITREX (POWDERED NITRILE EXAMINATION GLOVESD)
K952052 · Wembley Rubber Products (M) Sdn Bhd · Oct 1995
DISPOSABLE POLY GLOVES
K841676 · Abco Dealers, Inc. · May 1984