Cleared Traditional

K113837 - POWDER FREE VINYL PATIENT EXAMINATION GLOVES

K113837 is an FDA 510(k) clearance for POWDER FREE VINYL PATIENT EXAMINATION G..., manufactured by Hebei Changsheng Plastic 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 121-day FDA review.

K113837 · Hebei Changsheng Plastic Products Co., Ltd. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2012
Decision
121d
Days
Class 1
Risk

K113837 is an FDA 510(k) clearance for the POWDER FREE VINYL PATIENT EXAMINATION GLOVES. Classified as Vinyl Patient Examination Glove (product code LYZ), Class I - General Controls.

Submitted by Hebei Changsheng Plastic Products Co., Ltd. (Xingtai, Hebei Province, CN). The FDA issued a Cleared decision on April 27, 2012 after a review of 121 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 - K113837

510(k) Number K113837 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 28, 2011
Decision Date April 27, 2012
Days to Decision 121 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
8d faster than avg
Panel avg: 129d · This submission: 121d
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 K113837.
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, WHITE COLOR
K113194 · Suqian Ruijang Medical Supplies Co., Ltd. · May 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
DISPOSABLE POWDER FREE VINYL EXAM GLOVES
K120746 · Canopus Medical Supply Co., Ltd. · Apr 2012
DISPOSABLE POWDER FREE VINYL EXAM GLOVE, BLUE COLOR
K120190 · Rich Mountain Medical Products, Inc. · Apr 2012
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
K110536 · Zibo Tengyue Plastic Products Co., Ltd. · Mar 2012
K113837 · POWDER FREE VINYL PATIENT EXAMINATION GLOVES
Download PDF FDA Summary Hebei Changsheng Plas…