Cleared Traditional

K073193 - POWDER-FREE VINYL PATIENT EXAMINATION GLOVES

K073193 is an FDA 510(k) clearance for POWDER-FREE VINYL PATIENT EXAMINATION G..., manufactured by Shijiazhuang Prosperous 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 37-day FDA review.

K073193 · Shijiazhuang Prosperous Plastic Co., Ltd. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2007
Decision
37d
Days
Class 1
Risk

K073193 is an FDA 510(k) clearance for the POWDER-FREE VINYL PATIENT EXAMINATION GLOVES. Classified as Vinyl Patient Examination Glove (product code LYZ), Class I - General Controls.

Submitted by Shijiazhuang Prosperous Plastic Co., Ltd. (Beijing, CN). The FDA issued a Cleared decision on December 20, 2007 after a review of 37 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 - K073193

510(k) Number K073193 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 2007
Decision Date December 20, 2007
Days to Decision 37 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
92d faster than avg
Panel avg: 129d · This submission: 37d
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 K073193.
VINYL EXAMINATION GLOVE, POWDERED
K072223 · Pinnacle Co., Ltd. · Feb 2008
VINYL EXAMINATION GLOVE POWDER FREE
K072227 · Pinnacle Co., Ltd. · Feb 2008
SYNTHETIC VINYL EXAMINATION GLOVE POWDER FREE (YELLOW/WHITE)
K072228 · Pinnacle Co., Ltd. · Feb 2008
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
DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES, WITH ALOE VERA, GREEN COLOR
K072314 · Xuzhou Full Sun Medical Products , Ltd. · Dec 2007
K073193 · POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
Download PDF FDA Summary Shijiazhuang Prospero…