Cleared Traditional

K121157 - POWDER-FREE VIVYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)

K121157 is an FDA 510(k) clearance for POWDER-FREE VIVYL PATIENT EXAMINATION G..., manufactured by Shijazhuang Jiuyuan Plastic Co., Ltd.. The device is a Class 1 General Hospital device with product code LYZ cleared through the Traditional 510(k) pathway after a 108-day FDA review.

K121157 · Shijazhuang Jiuyuan Plastic Co., Ltd. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2012
Decision
108d
Days
Class 1
Risk

K121157 is an FDA 510(k) clearance for the POWDER-FREE VIVYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED). Classified as Vinyl Patient Examination Glove (product code LYZ), Class I - General Controls.

Submitted by Shijazhuang Jiuyuan Plastic Co., Ltd. (Beijing, CN). The FDA issued a Cleared decision on August 2, 2012 after a review of 108 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 - K121157

510(k) Number K121157 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 16, 2012
Decision Date August 02, 2012
Days to Decision 108 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
21d faster than avg
Panel avg: 129d · This submission: 108d
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 K121157.
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
K122266 · Shandong Junfeng Industries Co., Ltd. · Sep 2012
POWER-FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR(NON-COLORED)
K120968 · Tangshan Zhonghong Pulin Plastic Co.,Ltd · Sep 2012
POWDER FREE VINYL PATIENT EXAMINATION GLOVE
K112741 · Lifestyle Safty Products (Hui Zhou) Co., Ltd. · Sep 2012
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
K121157 · POWDER-FREE VIVYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
Download PDF FDA Summary Shijazhuang Jiuyuan P…