Cleared Traditional

K112222 - ALCATRON AND / OR MULTIPLE BRAND

K112222 is an FDA 510(k) clearance for ALCATRON AND / OR MULTIPLE BRAND, manufactured by Alcatron Gloves Factory. The device is a Class 1 General Hospital device with product code LYZ cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K112222 · Alcatron Gloves Factory · General Hospital
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Oct 2011
Decision
86d
Days
Class 1
Risk

K112222 is an FDA 510(k) clearance for the ALCATRON AND / OR MULTIPLE BRAND. Classified as Vinyl Patient Examination Glove (product code LYZ), Class I - General Controls.

Submitted by Alcatron Gloves Factory (Shandong, CN). The FDA issued a Cleared decision on October 27, 2011 after a review of 86 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 Alcatron Gloves Factory devices

FDA 510(k) Submission Details - K112222

510(k) Number K112222 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 02, 2011
Decision Date October 27, 2011
Days to Decision 86 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
43d faster than avg
Panel avg: 129d · This submission: 86d
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 660
Devices cleared under the same product code (LYZ) and FDA review panel - the closest regulatory comparables to K112222.
SYNTHETIC VINYL EXAMINATION GLOVES, POWDER FREE (AND MULTIPLE LABELS)
K112610 · Inpro Technology Device Factory · Dec 2011
POWER FREE VINYL PATIENT EXAMINATION GLOVES, YELLOW COLOR
K113191 · Suqian Ruijang Medical Supplies Co., Ltd. · Nov 2011
POWDERED VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
K113195 · Suqian Ruijang Medical Supplies Co., Ltd. · Nov 2011
SYNTHETIC VINYL EXAMINATION GLOVE POWDER FREE
K111857 · Inmed Gloves Factory · Sep 2011
POWDER-FREE YELLOW SYNTHETIC VINYL PATIENT EXAMINATION GLOVES
K110945 · Zhaoyang Plastic Co., Ltd. · Sep 2011
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
K110944 · Wangda Plastic Co., Ltd. · Sep 2011