Cleared Traditional

K905031 - PATIENT EXAMINATION GLOVES

K905031 is an FDA 510(k) clearance for PATIENT EXAMINATION GLOVES, manufactured by Phoenix Medical Technology, Inc.. The device is a Class 1 General Hospital device with product code LYZ cleared through the Traditional 510(k) pathway after a 72-day FDA review.

K905031 · Phoenix Medical Technology, Inc. · General Hospital
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Jan 1991
Decision
72d
Days
Class 1
Risk

K905031 is an FDA 510(k) clearance for the PATIENT EXAMINATION GLOVES. Classified as Vinyl Patient Examination Glove (product code LYZ), Class I - General Controls.

Submitted by Phoenix Medical Technology, Inc. (Andrews, US). The FDA issued a Cleared decision on January 18, 1991 after a review of 72 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K905031

510(k) Number K905031 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 07, 1990
Decision Date January 18, 1991
Days to Decision 72 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
57d faster than avg
Panel avg: 129d · This submission: 72d
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 798
Devices cleared under the same product code (LYZ) and FDA review panel - the closest regulatory comparables to K905031.
JM GLOVES STERILE VINYL EXAMINATION
K910775 · Jm Gloves Co., Ltd. · Mar 1991
VINYL GLOVE-POWEDERFREE (OBERON GLOVES INTL. LTD)
K903847 · Zest Mark Industrial Co., Ltd. · Jan 1991
TRU-TOUCH POWDER FREE
K905503 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jan 1991
PM GLOVE
K905055 · Pm Gloves, Inc. · Jan 1991
VINYL EXAMINATION GLOVES(MFG:KAO YING INDUSTRIAL)
K904642 · Predex Co. , Ltd. · Oct 1990
PATIENT EXAM GLOVES (MFG. SUN FLOWER GLOVE CO.)
K893072 · Innovative Medical Suppliers · May 1990
K905031 · PATIENT EXAMINATION GLOVES
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