Cleared Abbreviated

K072401 - DISPOSABLE POWDER FREE VINYL EXAM GLOVE YELLOW COLOR

K072401 is an FDA 510(k) clearance for DISPOSABLE POWDER FREE VINYL EXAM GLOVE..., manufactured by Xuzhou Full Sun Medical Products , Ltd.. The device is a Class 1 General Hospital device with product code LYZ cleared through the Abbreviated 510(k) pathway after a 49-day FDA review.

K072401 · Xuzhou Full Sun Medical Products , Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2007
Decision
49d
Days
Class 1
Risk

K072401 is an FDA 510(k) clearance for the DISPOSABLE POWDER FREE VINYL EXAM GLOVE YELLOW COLOR. Classified as Vinyl Patient Examination Glove (product code LYZ), Class I - General Controls.

Submitted by Xuzhou Full Sun Medical Products , Ltd. (Jiangsu, CN). The FDA issued a Cleared decision on October 15, 2007 after a review of 49 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Xuzhou Full Sun Medical Products , Ltd. devices

FDA 510(k) Submission Details - K072401

510(k) Number K072401 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 27, 2007
Decision Date October 15, 2007
Days to Decision 49 days
Submission Type Abbreviated
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
80d faster than avg
Panel avg: 129d · This submission: 49d
Pathway characteristics
Standards-based clearance path.

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 662
Devices cleared under the same product code (LYZ) and FDA review panel - the closest regulatory comparables to K072401.
DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES, WITH ALOE VERA, GREEN COLOR
K072314 · Xuzhou Full Sun Medical Products , Ltd. · Dec 2007
DISPOSABLE VINYL EXAMINATION GLOVE, POWDERED
K072472 · Xuzhou Full Sun Medical Products , Ltd. · Oct 2007
LANFAN POWDER-FREE VINYL EXAM GLOVES
K072488 · Shanghai Lanfan Co., Ltd. · Oct 2007
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
K072085 · Zibo Hongye Shangqin Plastic Rubbert Co, Ltd. · Sep 2007
POWDERED VINYL PATIENT EXAMINATION GLOVES
K071686 · Langfang Huilong Plastic Product Co., Ltd. · Aug 2007
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
K072001 · Tangshan Hongyun Plastic Products Co., Ltd. · Aug 2007