Cleared Traditional

K053521 - PRE-POWDERED STERILE VINYL GLOVE, CLEAR

K053521 is an FDA 510(k) clearance for PRE-POWDERED STERILE VINYL GLOVE, manufactured by Shijiazhuang Hongxiang Plastics 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 100-day FDA review.

K053521 · Shijiazhuang Hongxiang Plastics Products Co; , Ltd. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2006
Decision
100d
Days
Class 1
Risk

K053521 is an FDA 510(k) clearance for the PRE-POWDERED STERILE VINYL GLOVE, CLEAR. Classified as Vinyl Patient Examination Glove (product code LYZ), Class I - General Controls.

Submitted by Shijiazhuang Hongxiang Plastics Products Co; , Ltd. (Chino, US). The FDA issued a Cleared decision on March 29, 2006 after a review of 100 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 - K053521

510(k) Number K053521 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 19, 2005
Decision Date March 29, 2006
Days to Decision 100 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
29d faster than avg
Panel avg: 129d · This submission: 100d
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 K053521.
POWDERED VINYL PATIENT EXAMINATION GLOVES
K060886 · Wei Fang Jiuzhou Gloves Co., Ltd. · May 2006
SYNTHETIC VINYL PATIENT EXAMINATION GLOVE-POWERED
K060784 · Ever Light Plastic Products Co., Ltd. · May 2006
SYNTHETIC VINYL PATIENT EXAMINATION GLOVE-POWDER FREE
K060778 · Ever Light Plastic Products Co., Ltd. · Apr 2006
POWDER FREE STERILE VINYL GLOVE (CLEAR AND YELLOW)
K053523 · Shijiazhuang Hongxiang Plastics Products Co; , Ltd. · Feb 2006
POWDERED VINYL PATIENT EXAMINATION GLOVES, WHITE (NON-COLORED)
K052729 · Shijiazhuang Brilliant Ocean Plastic Co., Ltd. · Jan 2006
POWDER FREE VINYL EXAMINATION GLOVE
K052985 · Tg Medical (China) Incorporation · Jan 2006
K053521 · PRE-POWDERED STERILE VINYL GLOVE, CLEAR
Download PDF FDA Summary Shijiazhuang Hongxian…