Cleared Traditional

PATIENT EXAM GLOVES (MFG. SUN FLOWER GLOVE CO.) (K893072) - FDA 510(k) Clearance

Class I General Hospital device.

K893072 · Innovative Medical Suppliers · General Hospital
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May 1990
Decision
400d
Days
Class 1
Risk

K893072 is an FDA 510(k) clearance for the PATIENT EXAM GLOVES (MFG. SUN FLOWER GLOVE CO.). Classified as Vinyl Patient Examination Glove (product code LYZ), Class I - General Controls.

Submitted by Innovative Medical Suppliers (Cardiff, US). The FDA issued a Cleared decision on May 18, 1990 after a review of 400 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Innovative Medical Suppliers devices

Submission Details

510(k) Number K893072 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 13, 1989
Decision Date May 18, 1990
Days to Decision 400 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
271d slower than avg
Panel avg: 129d · This submission: 400d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 84
Devices cleared under the same product code (LYZ) and FDA review panel - the closest regulatory comparables to K893072.
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