Cleared Traditional

K063471 - SHIJIAZHUANG JUNFEI PLASTICS PRODUCTS CO., LTD. POWDER FREE (WHITE) VINYL PATIENT EXAMINATION GLOVES

K063471 is an FDA 510(k) clearance for SHIJIAZHUANG JUNFEI PLASTICS PRODUCTS CO., manufactured by Shijiazhuang Junfei 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 104-day FDA review.

K063471 · Shijiazhuang Junfei Plastic Products Co., Ltd. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2007
Decision
104d
Days
Class 1
Risk

K063471 is an FDA 510(k) clearance for the SHIJIAZHUANG JUNFEI PLASTICS PRODUCTS CO., LTD. POWDER FREE (WHITE) VINYL PAT.... Classified as Vinyl Patient Examination Glove (product code LYZ), Class I - General Controls.

Submitted by Shijiazhuang Junfei Plastic Products Co., Ltd. (Chino, US). The FDA issued a Cleared decision on February 28, 2007 after a review of 104 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 - K063471

510(k) Number K063471 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 16, 2006
Decision Date February 28, 2007
Days to Decision 104 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
25d faster than avg
Panel avg: 129d · This submission: 104d
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 K063471.
POWDERED (WHITE) VINYL PATIENT EXAMINATION
K070027 · Shijiazhuang Lianhe Shunda Plastic Products Co., L · Mar 2007
POWDER FREE VINYL PATIENT EXAMINATION GLOVE, YELLOW
K070188 · Hong DI Plastic Products Co., Ltd. · Mar 2007
POWDERED (YELLOW) VINYL PATIENT EXAMINATION GLOVES
K070026 · Shijiazhuang Lianhe Shunda Plastic Products Co., L · Mar 2007
POWDERED VINYL PATIENT EXAMINATION GLOVES
K070145 · Wuxi Shenzhou Plastic Products Co., Ltd. · Feb 2007
POWDERED VINYL PATIENT EXAMINATION GLOVES, YELLOW
K070042 · Super Safe Plastic Products Co., Ltd. · Feb 2007
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
K070149 · Wuxi Shenzhou Plastic Products Co., Ltd. · Feb 2007
K063471 · SHIJIAZHUANG JUNFEI PLASTICS PRODUCTS CO., LTD. POWDER FREE (WHITE) VINYL PATIENT EXAMINATION GLOVES
Download PDF FDA Summary Shijiazhuang Junfei P…