Cleared Traditional

K052985 - POWDER FREE VINYL EXAMINATION GLOVE

K052985 is an FDA 510(k) clearance for POWDER FREE VINYL EXAMINATION GLOVE, manufactured by Tg Medical (China) Incorporation. The device is a Class 1 General Hospital device with product code LYZ cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K052985 · Tg Medical (China) Incorporation · General Hospital
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Jan 2006
Decision
87d
Days
Class 1
Risk

K052985 is an FDA 510(k) clearance for the POWDER FREE VINYL EXAMINATION GLOVE. Classified as Vinyl Patient Examination Glove (product code LYZ), Class I - General Controls.

Submitted by Tg Medical (China) Incorporation (Zhangjiagang, Jiangsu Province, CN). The FDA issued a Cleared decision on January 19, 2006 after a review of 87 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 - K052985

510(k) Number K052985 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 24, 2005
Decision Date January 19, 2006
Days to Decision 87 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
42d faster than avg
Panel avg: 129d · This submission: 87d
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 K052985.
PRE-POWDERED STERILE VINYL GLOVE, CLEAR
K053521 · Shijiazhuang Hongxiang Plastics Products Co; , Ltd. · Mar 2006
POWDER FREE STERILE VINYL GLOVE (CLEAR AND YELLOW)
K053523 · Shijiazhuang Hongxiang Plastics Products Co; , Ltd. · Feb 2006
POWDERED VINYL PATIENT EXAMINATION GLOVES, WHITE (NON-COLORED)
K052729 · Shijiazhuang Brilliant Ocean Plastic Co., Ltd. · Jan 2006
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
K052985 · POWDER FREE VINYL EXAMINATION GLOVE
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