Cleared Traditional

K042120 - POWDERED VINYL PATIENT EXAMINATION GLOVES

K042120 is an FDA 510(k) clearance for POWDERED VINYL PATIENT EXAMINATION GLOVES, manufactured by Shijiazhuang Manful Light Industrial Products Co.,. The device is a Class 1 General Hospital device with product code LYZ cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K042120 · Shijiazhuang Manful Light Industrial Products Co., · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2004
Decision
90d
Days
Class 1
Risk

K042120 is an FDA 510(k) clearance for the POWDERED VINYL PATIENT EXAMINATION GLOVES. Classified as Vinyl Patient Examination Glove (product code LYZ), Class I - General Controls.

Submitted by Shijiazhuang Manful Light Industrial Products Co., (Chaoyang; Beijing, CN). The FDA issued a Cleared decision on November 4, 2004 after a review of 90 days - within the typical 510(k) review window.

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 - K042120

510(k) Number K042120 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 06, 2004
Decision Date November 04, 2004
Days to Decision 90 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
39d faster than avg
Panel avg: 129d · This submission: 90d
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 798
Devices cleared under the same product code (LYZ) and FDA review panel - the closest regulatory comparables to K042120.
POWDERED VINYL PATIENT EXAMINATION GLOVES, WHITE (NON-COLORED)
K043477 · Shijiazhuang Winful Plastic Co., Ltd. · Jan 2005
POWDER FREE CLEAR SYNTHETIC VINYL EXAMINATION GLOVES, SMALL, MEDIUM, LARGE, X-LARGE
K043159 · Shijaizhuang Brilliant Ocean Plastic Co., Ltd. · Dec 2004
POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES
K042830 · Grand Work Plastic Products Co., Ltd. · Nov 2004
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
K042120 · POWDERED VINYL PATIENT EXAMINATION GLOVES
Download PDF FDA Summary Shijiazhuang Manful L…