Cleared Traditional

K072228 - SYNTHETIC VINYL EXAMINATION GLOVE POWDER FREE (YELLOW/WHITE)

K072228 is an FDA 510(k) clearance for SYNTHETIC VINYL EXAMINATION GLOVE POWDE..., manufactured by Pinnacle Co., Ltd.. The device is a Class 1 General Hospital device with product code LYZ cleared through the Traditional 510(k) pathway after a 182-day FDA review.

K072228 · Pinnacle Co., Ltd. · General Hospital
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Feb 2008
Decision
182d
Days
Class 1
Risk

K072228 is an FDA 510(k) clearance for the SYNTHETIC VINYL EXAMINATION GLOVE POWDER FREE (YELLOW/WHITE). Classified as Vinyl Patient Examination Glove (product code LYZ), Class I - General Controls.

Submitted by Pinnacle Co., Ltd. (Shandong, CN). The FDA issued a Cleared decision on February 8, 2008 after a review of 182 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K072228

510(k) Number K072228 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 10, 2007
Decision Date February 08, 2008
Days to Decision 182 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
53d slower than avg
Panel avg: 129d · This submission: 182d
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 750
Devices cleared under the same product code (LYZ) and FDA review panel - the closest regulatory comparables to K072228.
POWDERED VINYL PATIENT EXAMINATION GLOVES
K073192 · Shijiazhuang Prosperous Plastic Co., Ltd. · May 2008
VINYL EXAMINATION GLOVE, POWDERED
K072223 · Pinnacle Co., Ltd. · Feb 2008
VINYL EXAMINATION GLOVE POWDER FREE
K072227 · Pinnacle Co., Ltd. · Feb 2008
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
K073193 · Shijiazhuang Prosperous Plastic Co., Ltd. · Dec 2007
DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVE, WHITE COLOR
K072377 · Xuzhou Full Sun Medical Products , Ltd. · Dec 2007
DISPOSABLE POWDERED VINYL EXAM GLOVE, YELLOW COLOR
K071122 · Xuzhou Full Sun Medical Products , Ltd. · Dec 2007
K072228 · SYNTHETIC VINYL EXAMINATION GLOVE POWDER FREE (YELLOW/WHITE)
Download PDF Pinnacle Co., Ltd.