Cleared Traditional

K110016 - POWDER FREE VINYL PATIENT EXAMINATION GLOVES, COLORED (YELLOW)

K110016 is an FDA 510(k) clearance for POWDER FREE VINYL PATIENT EXAMINATION G..., manufactured by Rongyao Plastic Produce Co., Ltd.. The device is a Class 1 General Hospital device with product code LYZ cleared through the Traditional 510(k) pathway after a 232-day FDA review.

K110016 · Rongyao Plastic Produce Co., Ltd. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2011
Decision
232d
Days
Class 1
Risk

K110016 is an FDA 510(k) clearance for the POWDER FREE VINYL PATIENT EXAMINATION GLOVES, COLORED (YELLOW). Classified as Vinyl Patient Examination Glove (product code LYZ), Class I - General Controls.

Submitted by Rongyao Plastic Produce Co., Ltd. (Hengshuicity, CN). The FDA issued a Cleared decision on August 23, 2011 after a review of 232 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 - K110016

510(k) Number K110016 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 03, 2011
Decision Date August 23, 2011
Days to Decision 232 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
103d slower than avg
Panel avg: 129d · This submission: 232d
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 K110016.
POWDER-FREE YELLOW SYNTHETIC VINYL PATIENT EXAMINATION GLOVES
K110945 · Zhaoyang Plastic Co., Ltd. · Sep 2011
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
K110944 · Wangda Plastic Co., Ltd. · Sep 2011
SHENGKUN CHEMICAL
K110621 · Zibo Shengkun Chemical Industrial 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
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
K111752 · Shandong Jianhong New Material Company · Jul 2011
POWDERED VINYL PATIENT EXAMINATION GLOVES, LIGHT YELLOW COLOR (NON-COLORED)
K110966 · Ppp Medical and Safety Products Company Limited · Jul 2011
K110016 · POWDER FREE VINYL PATIENT EXAMINATION GLOVES, COLORED (YELLOW)
Download PDF FDA Summary Rongyao Plastic Produ…