Cleared Traditional

K042247 - SYNTHETIC (BLUE) VINYL PATIENT EXAMINATION GLOVES - POWDER FREE

K042247 is an FDA 510(k) clearance for SYNTHETIC (BLUE) VINYL PATIENT EXAMINAT..., manufactured by Shijiazhuang Hongxiang Plastics Products Co; , Ltd.. The device is a Class 1 General Hospital device with product code LYZ cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K042247 · Shijiazhuang Hongxiang Plastics Products Co; , Ltd. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2004
Decision
14d
Days
Class 1
Risk

K042247 is an FDA 510(k) clearance for the SYNTHETIC (BLUE) VINYL PATIENT EXAMINATION GLOVES - POWDER FREE. Classified as Vinyl Patient Examination Glove (product code LYZ), Class I - General Controls.

Submitted by Shijiazhuang Hongxiang Plastics Products Co; , Ltd. (Brea, US). The FDA issued a Cleared decision on September 2, 2004 after a review of 14 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 - K042247

510(k) Number K042247 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 19, 2004
Decision Date September 02, 2004
Days to Decision 14 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
115d faster than avg
Panel avg: 129d · This submission: 14d
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 K042247.
POWDER-FREE VINYL PATIENT EXAMINTION GLOVES
K042119 · Shijiazhuang Manful Light Industrial Products Co., · Nov 2004
POWDER-FREE NON-STERILE VINYL EXAMINATION GLOVES
K042214 · Shandong Perfect Plastic Co., Ltd. · Sep 2004
PRE-POWDERED NON-STERILE VINYL EXAMINATION GLOVES
K042213 · Shandong Perfect Plastic Co., Ltd. · Sep 2004
PRE-POWDERED VINYL EXAM GLOVES
K041379 · Shijiazhuang Wally Plastics Co., Ltd. · Aug 2004
POWDER-FREE BLUE VINYL EXAM GLOVES
K041945 · Glormed Intl., Inc. · Aug 2004
OPUE-E DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WITH VITAMIN COMPLEX, NOPAL AND LANOLIN
K040108 · Est International Corporation · Aug 2004
K042247 · SYNTHETIC (BLUE) VINYL PATIENT EXAMINATION GLOVES - POWDER FREE
Download PDF FDA Summary Shijiazhuang Hongxian…