Cleared Traditional

K111752 - POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)

K111752 is an FDA 510(k) clearance for POWDER FREE VINYL PATIENT EXAMINATION G..., manufactured by Shandong Jianhong New Material Company. The device is a Class 1 General Hospital device with product code LYZ cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K111752 · Shandong Jianhong New Material Company · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2011
Decision
35d
Days
Class 1
Risk

K111752 is an FDA 510(k) clearance for the POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED). Classified as Vinyl Patient Examination Glove (product code LYZ), Class I - General Controls.

Submitted by Shandong Jianhong New Material Company (Huan Zhong Rd, Beijing, CN). The FDA issued a Cleared decision on July 27, 2011 after a review of 35 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 - K111752

510(k) Number K111752 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 22, 2011
Decision Date July 27, 2011
Days to Decision 35 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
94d faster than avg
Panel avg: 129d · This submission: 35d
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 749
Devices cleared under the same product code (LYZ) and FDA review panel - the closest regulatory comparables to K111752.
SHENGKUN CHEMICAL
K110621 · Zibo Shengkun Chemical Industrial Co., Ltd. · Aug 2011
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, COLORED (YELLOW)
K110016 · Rongyao Plastic Produce Co., Ltd. · Aug 2011
SYNTHETIC EXAM GLOVE POWDER FREE COATED WITH ALLOGEL (GREEN/ BLUE / WHITE / MAGENTA / CLEAR - NON COLORED)
K103619 · Shandong Blue Sail Innovation Co., Ltd. · Aug 2011
POWDERED VINYL PATIENT EXAMINATION GLOVES, LIGHT YELLOW COLOR (NON-COLORED)
K110966 · Ppp Medical and Safety Products Company Limited · Jul 2011
POWDERED VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
K110970 · Ppp Medical and Safety Products Company Limited · Jul 2011
POWDER-FREE NON-STERILE VINYL EXAMINATION GLOVE
K111598 · Lpl (Hui Zhou) Glove Co., Ltd. · Jul 2011
K111752 · POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
Download PDF FDA Summary Shandong Jianhong New…