Cleared Traditional

K070519 - PRIME PROTECTION POWDERED VINYL EXAMINATION GLOVES

K070519 is an FDA 510(k) clearance for PRIME PROTECTION POWDERED VINYL EXAMINA..., manufactured by Zhang Jia Gang Huayuan Plastic Co. , Ltd.. The device is a Class 1 General Hospital device with product code LYZ cleared through the Traditional 510(k) pathway after a 47-day FDA review.

K070519 · Zhang Jia Gang Huayuan Plastic Co. , Ltd. · General Hospital
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Apr 2007
Decision
47d
Days
Class 1
Risk

K070519 is an FDA 510(k) clearance for the PRIME PROTECTION POWDERED VINYL EXAMINATION GLOVES. Classified as Vinyl Patient Examination Glove (product code LYZ), Class I - General Controls.

Submitted by Zhang Jia Gang Huayuan Plastic Co. , Ltd. (Zhang Jia Gang, Jiangsu, CN). The FDA issued a Cleared decision on April 10, 2007 after a review of 47 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 - K070519

510(k) Number K070519 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 22, 2007
Decision Date April 10, 2007
Days to Decision 47 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
82d faster than avg
Panel avg: 129d · This submission: 47d
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 K070519.
DISPOSABLE POWDER FREE VINYL EXAM GLOVE, YELLOW COLOR
K071123 · Xuzhou Full Sun Medical Products , Ltd. · Jul 2007
VINYL CO-POLYMER POWDER FREE EXAMINATION GLOVES, BLUE COLOR
K070852 · Shijiazhang Hongxiang Plastic Products Co., Ltd. · Jul 2007
POWDER-FREE VINYL EXAMINATION GLOVES
K071022 · Glormed Colombia S.A. · Jul 2007
POWDERED FREE (WHITE) VINYL PATIENT EXAMINATION GLOVES
K070041 · Shijiazhuang Lianhe Shunda Plastic Products Co., L · Mar 2007
POWDER FREE VINYL PATIENT EXAMINATION GLOVE, YELLOW
K070038 · Super Safe Plastic Products Co., Ltd. · Mar 2007
POWDERED (WHITE) VINYL PATIENT EXAMINATION
K070027 · Shijiazhuang Lianhe Shunda Plastic Products Co., L · Mar 2007
K070519 · PRIME PROTECTION POWDERED VINYL EXAMINATION GLOVES
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