Cleared Traditional

K950033 - POLYDERM

K950033 is an FDA 510(k) clearance for POLYDERM, manufactured by Wilshire Technologies. The device is a Class 1 General Hospital device with product code LZA cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K950033 · Wilshire Technologies · General Hospital
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Apr 1995
Decision
90d
Days
Class 1
Risk

K950033 is an FDA 510(k) clearance for the POLYDERM. Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Wilshire Technologies (Carlsbadd, US). The FDA issued a Cleared decision on April 4, 1995 after a review of 90 days - within the typical 510(k) review window.

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 Wilshire Technologies devices

FDA 510(k) Submission Details - K950033

510(k) Number K950033 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 04, 1995
Decision Date April 04, 1995
Days to Decision 90 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
39d faster than avg
Panel avg: 129d · This submission: 90d
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 976
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K950033.
SCINITREX BLUE POWDERED NITRILE EXAMINATION GLOVES
K952155 · 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