Cleared Traditional

K052922 - GREAT GLOVE POWDERED VINYL EXAMINATION GLOVES

K052922 is an FDA 510(k) clearance for GREAT GLOVE POWDERED VINYL EXAMINATION ..., manufactured by Great Glove (China), Inc.. The device is a Class 1 General Hospital device with product code LYZ cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K052922 · Great Glove (China), Inc. · General Hospital
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Dec 2005
Decision
63d
Days
Class 1
Risk

K052922 is an FDA 510(k) clearance for the GREAT GLOVE POWDERED VINYL EXAMINATION GLOVES. Classified as Vinyl Patient Examination Glove (product code LYZ), Class I - General Controls.

Submitted by Great Glove (China), Inc. (Zhangjiagang, Jiangsu, CN). The FDA issued a Cleared decision on December 20, 2005 after a review of 63 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 - K052922

510(k) Number K052922 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 18, 2005
Decision Date December 20, 2005
Days to Decision 63 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
66d faster than avg
Panel avg: 129d · This submission: 63d
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 K052922.
DISPOSABLE PVC EXAMINATION GLOVE, POWDERED AND POWDER-FREE
K053259 · Practical Protective Plastic Manufactory , Ltd. · Jan 2006
POWDERED VINYL EXAMINATION GLOVE
K052984 · Tg Medical (China) Incorporation · Jan 2006
GREAT GLOVE POWDER FREE VINYL EXAMINATION GLOVES
K052923 · Great Glove (China), Inc. · Dec 2005
TEH LOONG POWDERED SYNTHETIC VINYL PATIENT EXAMINATION GLOVES, YELLOW
K052635 · Teh Loong Corp. · Dec 2005
ESTEEM STRETCHY VINYL GLOVE WITH COATING
K052568 · Cardinalhealth · Nov 2005
DISPOSABLE POWDER FREE VINYL EXAM GLOVES WITH VITAMIN COMPLEX, NOPAL AND LANOLIN BLUE COLOR
K052612 · Shanghai Antares Industries, Inc. · Nov 2005
K052922 · GREAT GLOVE POWDERED VINYL EXAMINATION GLOVES
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