Cleared Traditional

K070852 - VINYL CO-POLYMER POWDER FREE EXAMINATION GLOVES, BLUE COLOR

K070852 is an FDA 510(k) clearance for VINYL CO-POLYMER POWDER FREE EXAMINATIO..., manufactured by Shijiazhang Hongxiang 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 107-day FDA review.

K070852 · Shijiazhang Hongxiang Plastic Products Co., Ltd. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2007
Decision
107d
Days
Class 1
Risk

K070852 is an FDA 510(k) clearance for the VINYL CO-POLYMER POWDER FREE EXAMINATION GLOVES, BLUE COLOR. Classified as Vinyl Patient Examination Glove (product code LYZ), Class I - General Controls.

Submitted by Shijiazhang Hongxiang Plastic Products Co., Ltd. (Chino, US). The FDA issued a Cleared decision on July 13, 2007 after a review of 107 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 - K070852

510(k) Number K070852 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 28, 2007
Decision Date July 13, 2007
Days to Decision 107 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
22d faster than avg
Panel avg: 129d · This submission: 107d
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 K070852.
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
K072001 · Tangshan Hongyun Plastic Products Co., Ltd. · Aug 2007
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
K071685 · Langfang Huilong Plastic Product Co., Ltd. · Aug 2007
DISPOSABLE POWDER FREE VINYL EXAM GLOVE, YELLOW COLOR
K071123 · Xuzhou Full Sun Medical Products , Ltd. · Jul 2007
POWDER-FREE VINYL EXAMINATION GLOVES
K071022 · Glormed Colombia S.A. · Jul 2007
PRIME PROTECTION POWDERED VINYL EXAMINATION GLOVES
K070519 · Zhang Jia Gang Huayuan Plastic Co. , Ltd. · Apr 2007
POWDERED FREE (WHITE) VINYL PATIENT EXAMINATION GLOVES
K070041 · Shijiazhuang Lianhe Shunda Plastic Products Co., L · Mar 2007
K070852 · VINYL CO-POLYMER POWDER FREE EXAMINATION GLOVES, BLUE COLOR
Download PDF FDA Summary Shijiazhang Hongxiang…