Cleared Traditional

K113193 - PATIENT EXAMINATION GLOVE

K113193 is an FDA 510(k) clearance for PATIENT EXAMINATION GLOVE, 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 46-day FDA review.

K113193 · 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
Dec 2011
Decision
46d
Days
Class 1
Risk

K113193 is an FDA 510(k) clearance for the PATIENT EXAMINATION GLOVE. 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 December 16, 2011 after a review of 46 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 - K113193

510(k) Number K113193 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 31, 2011
Decision Date December 16, 2011
Days to Decision 46 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
83d faster than avg
Panel avg: 129d · This submission: 46d
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 K113193.
DISPOSABLE POWDER FREE VINYL EXAM GLOVE, YELLOW COLOR
K113710 · Full Synergy Medical Products, Inc. · Feb 2012
DISPOSABLE POWDER FREE VINYL EXAM GLOVE, BLUE COLOR
K113722 · Full Synergy Medical Products, Inc. · Feb 2012
SAME/VARIOUS DISTRIBUTORS/WE MAY PRIVATE LABEL
K112743 · Clean Medical Manfacturing Co;Ltd · Dec 2011
SYNTHETIC VINYL EXAMINATION GLOVES, POWDER FREE (AND MULTIPLE LABELS)
K112610 · Inpro Technology Device Factory · Dec 2011
POWER FREE VINYL PATIENT EXAMINATION GLOVES, YELLOW COLOR
K113191 · Suqian Ruijang Medical Supplies Co., Ltd. · Nov 2011
POWDERED VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
K113195 · Suqian Ruijang Medical Supplies Co., Ltd. · Nov 2011
K113193 · PATIENT EXAMINATION GLOVE
Download PDF FDA Summary Suqian Ruijang Medica…