Cleared Traditional

K071999 - POWDERED VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)

K071999 is an FDA 510(k) clearance for POWDERED VINYL PATIENT EXAMINATION GLOVES, manufactured by Tangshan Hongyun 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 290-day FDA review.

K071999 · Tangshan Hongyun Plastic Products Co., Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2008
Decision
290d
Days
Class 1
Risk

K071999 is an FDA 510(k) clearance for the POWDERED VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED). Classified as Vinyl Patient Examination Glove (product code LYZ), Class I - General Controls.

Submitted by Tangshan Hongyun Plastic Products Co., Ltd. (Huan Zhong, Roa; Beijing, CN). The FDA issued a Cleared decision on May 8, 2008 after a review of 290 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.

View all Tangshan Hongyun Plastic Products Co., Ltd. devices

FDA 510(k) Submission Details - K071999

510(k) Number K071999 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 23, 2007
Decision Date May 08, 2008
Days to Decision 290 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
161d slower than avg
Panel avg: 129d · This submission: 290d
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 640
Devices cleared under the same product code (LYZ) and FDA review panel - the closest regulatory comparables to K071999.
POWDERED VINYL PATIENT EXAMINATION GLOVES, (LIGHT YELLOW)
K081657 · Jiangsu Cureguard Glove Co., Ltd. · Aug 2008
DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES, WHITE COLOR
K081535 · Rich Mountain Medical Products, Inc. · Aug 2008
POWDER FREE VINYL PATIENT EXAMINATION GLOVES (LIGHT YELLOW)
K081655 · Jiangsu Cureguard Glove Co., Ltd. · Jul 2008
POWDERED VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
K072084 · Zibo Hongye Shangqin Plastic Rubbert Co, Ltd. · May 2008
POWDERED VINYL PATIENT EXAMINATION GLOVES
K073192 · Shijiazhuang Prosperous Plastic Co., Ltd. · May 2008
VINYL EXAMINATION GLOVE, POWDERED
K072223 · Pinnacle Co., Ltd. · Feb 2008