Cleared Traditional

K111012 - SYNTHETIC VINYL EXAMINATION GLOVES, POWDER FREE (BLUE/GREEN) (AND MULTIPLE LABELS)

K111012 is an FDA 510(k) clearance for SYNTHETIC VINYL EXAMINATION GLOVES, manufactured by True Glove Factory. The device is a Class 1 General Hospital device with product code LYZ cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K111012 · True Glove Factory · General Hospital
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Jul 2011
Decision
85d
Days
Class 1
Risk

K111012 is an FDA 510(k) clearance for the SYNTHETIC VINYL EXAMINATION GLOVES, POWDER FREE (BLUE/GREEN) (AND MULTIPLE LA.... Classified as Vinyl Patient Examination Glove (product code LYZ), Class I - General Controls.

Submitted by True Glove Factory (Weifang, Shandong, CN). The FDA issued a Cleared decision on July 6, 2011 after a review of 85 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 - K111012

510(k) Number K111012 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 12, 2011
Decision Date July 06, 2011
Days to Decision 85 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
44d faster than avg
Panel avg: 129d · This submission: 85d
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 749
Devices cleared under the same product code (LYZ) and FDA review panel - the closest regulatory comparables to K111012.
POWDER-FREE NON-STERILE VINYL EXAMINATION GLOVE
K111598 · Lpl (Hui Zhou) Glove Co., Ltd. · Jul 2011
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, YELLOW COLOR
K110857 · Shandong Zhanpeng Medical Products Co., Ltd. · Jul 2011
DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVE, BLUE COLOR
K111240 · Xuzhou Full Sun Medical Products , Ltd. · Jul 2011
SYNTHETIC VINYL EXAMINATION GLOVES, POWDER FREE (AND MULTIPLE LABELS)
K111297 · Premier Medical Gloves Factory · Jun 2011
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, LIGHT YELLOW COLOR
K111459 · Jiangsu Alfa Glove Co., Ltd. · Jun 2011
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
K110969 · Ppp Medical and Safety Products Company Limited · Jun 2011
K111012 · SYNTHETIC VINYL EXAMINATION GLOVES, POWDER FREE (BLUE/GREEN) (AND MULTIPLE LABELS)
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