Cleared Traditional

K897081 - ANSELL CONFORM GREEN EXAMINATION GLOVES

K897081 is an FDA 510(k) clearance for ANSELL CONFORM GREEN EXAMINATION GLOVES, manufactured by Ansell, Inc.. The device is a Class 1 General Hospital device with product code LYZ cleared through the Traditional 510(k) pathway after a 97-day FDA review.

K897081 · Ansell, Inc. · General Hospital
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Mar 1990
Decision
97d
Days
Class 1
Risk

K897081 is an FDA 510(k) clearance for the ANSELL CONFORM GREEN EXAMINATION GLOVES. Classified as Vinyl Patient Examination Glove (product code LYZ), Class I - General Controls.

Submitted by Ansell, Inc. (Thailand, TH). The FDA issued a Cleared decision on March 26, 1990 after a review of 97 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 Ansell, Inc. devices

FDA 510(k) Submission Details - K897081

510(k) Number K897081 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 19, 1989
Decision Date March 26, 1990
Days to Decision 97 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
32d faster than avg
Panel avg: 129d · This submission: 97d
Pathway characteristics
Predicate-based equivalence.

LYZ Device Classification - Class 1, General Controls

Product Code LYZ Vinyl Patient Examination Glove
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6250
Definition A Vinyl Patient Examination Glove Is A Disposable Device Made Of Poly(vinyl Chloride) 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 - LYZ Vinyl Patient Examination Glove

All 453
Devices cleared under the same product code (LYZ) and FDA review panel - the closest regulatory comparables to K897081.
SENSICARE SYNTHETIC MEDICAL GLOVES
K915478 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jan 1992
B-D(R) HYPOALLERGENIIC NON-STERILE PAT EXAM GLOVES
K913902 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Sep 1991
TRU-TOUCH POWDER FREE
K905503 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jan 1991
TRU-TOUCH VINYL, NON-STERILE
K891719 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Dec 1989
TRU-TOUCH VINYL, STERILE
K892327 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Dec 1989
FEATHERWEIGHT VINYL, NON-STERILE EXAM GLOVES
K892328 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Dec 1989