Cleared Traditional

K011186 - POWDER-FREE STERILE SYNTHETIC VINYL EXA...

K011186 is an FDA 510(k) clearance for POWDER-FREE STERILE SYNTHETIC VINYL EXA..., manufactured by Allegiance Healthcare Corp.. The device is a Class 1 General Hospital device with product code LYZ cleared through the Traditional 510(k) pathway after a 37-day FDA review.

K011186 · Allegiance Healthcare Corp. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2001
Decision
37d
Days
Class 1
Risk

K011186 is an FDA 510(k) clearance for the POWDER-FREE STERILE SYNTHETIC VINYL EXAMINATION GLOVES. Classified as Vinyl Patient Examination Glove (product code LYZ), Class I - General Controls.

Submitted by Allegiance Healthcare Corp. (Mcgraw Park, US). The FDA issued a Cleared decision on May 25, 2001 after a review of 37 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.

View all Allegiance Healthcare Corp. devices

FDA 510(k) Submission Details - K011186

510(k) Number K011186 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 18, 2001
Decision Date May 25, 2001
Days to Decision 37 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
92d faster than avg
Panel avg: 129d · This submission: 37d
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 99
Devices cleared under the same product code (LYZ) and FDA review panel - the closest regulatory comparables to K011186.
POWDER-FREE SYNTHETIC VINYL EXAMINATION GLOVES, BLUE COLOR
K032084 · Shen Wei (Usa), Inc. · Oct 2003
SAFESKIN* BLUE ZONE POWDER-FREE VINYL EXAM GLOVE
K031750 · Kimberly-Clark Corp. · Oct 2003
STERILE POWDER FREE SYNTHETIC VINYL PATIENT EXAM GLOVE
K012282 · Cypress Medical Products, Ltd. · Aug 2001
MEDLINE STERILE VINYL EXAM GLOVES, POWDER FREE, YELLOW
K003091 · Medline Industries, Inc. · Oct 2000
SENSICARE XP VINYL POWDER FREE MEDICAL EXAMINATION GLOVE
K992865 · Maxxim Medical · Oct 1999
SAFESKIN SYNTHETIC BINYO POWDER-FREE POLYMER COATED EXAMINATION GLOVES (GREEN, WHITE)
K991951 · Safeskin Corp. · Jul 1999