Cleared Traditional

K113194 - POWDER FREE VINYL PATIENT EXAMINATION GLOVES, WHITE COLOR

K113194 is an FDA 510(k) clearance for POWDER FREE VINYL PATIENT EXAMINATION G..., manufactured by Suqian Ruijang Medical Supplies Co., Ltd.. The device is a Class 1 General Hospital device with product code LYZ cleared through the Traditional 510(k) pathway after a 196-day FDA review.

K113194 · Suqian Ruijang Medical Supplies Co., Ltd. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2012
Decision
196d
Days
Class 1
Risk

K113194 is an FDA 510(k) clearance for the POWDER FREE VINYL PATIENT EXAMINATION GLOVES, WHITE COLOR. Classified as Vinyl Patient Examination Glove (product code LYZ), Class I - General Controls.

Submitted by Suqian Ruijang Medical Supplies Co., Ltd. (Chu Xiaoan, CN). The FDA issued a Cleared decision on May 14, 2012 after a review of 196 days - an extended review 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: 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 - K113194

510(k) Number K113194 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 31, 2011
Decision Date May 14, 2012
Days to Decision 196 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
67d slower than avg
Panel avg: 129d · This submission: 196d
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 741
Devices cleared under the same product code (LYZ) and FDA review panel - the closest regulatory comparables to K113194.
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, NON-STERILE
K120230 · Shandong Taixiang Medical Products Co., Ltd. · Jul 2012
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
K120797 · Shandong Shouguang Kingliyuan Medical Apparatus & · Jul 2012
POWER FREE STRETCH VINYL PATIENT EXAMINATION GLOVES
K120584 · Wealth on (Jiangsu) Co., Ltd. · Jul 2012
DISPOSABLE POWER FREE VINYL EXAM GLOVE, PINK COLOR
K120798 · Canopus Medical Supply Co., Ltd. · May 2012
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, YELLOW COLOR
K112266 · Shandong Zhiyuan Medical Products Co., Ltd. · May 2012
POWDER FREE VINYL PATIENT EXAMINATION GLOVES
K113837 · Hebei Changsheng Plastic Products Co., Ltd. · Apr 2012
K113194 · POWDER FREE VINYL PATIENT EXAMINATION GLOVES, WHITE COLOR
Download PDF FDA Summary Suqian Ruijang Medica…