Cleared Traditional

K100734 - POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)

K100734 is an FDA 510(k) clearance for POWDER FREE VINYL PATIENT EXAMINATION G..., manufactured by Huanfu Plastic Products Limited. The device is a Class 1 General Hospital device with product code LYZ cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K100734 · Huanfu Plastic Products Limited · General Hospital
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Optimized for regulatory review, auditing and printing
May 2010
Decision
64d
Days
Class 1
Risk

K100734 is an FDA 510(k) clearance for the POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED). Classified as Vinyl Patient Examination Glove (product code LYZ), Class I - General Controls.

Submitted by Huanfu Plastic Products Limited (Beijing, CN). The FDA issued a Cleared decision on May 18, 2010 after a review of 64 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Huanfu Plastic Products Limited devices

FDA 510(k) Submission Details - K100734

510(k) Number K100734 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 15, 2010
Decision Date May 18, 2010
Days to Decision 64 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
65d faster than avg
Panel avg: 129d · This submission: 64d
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 143
Devices cleared under the same product code (LYZ) and FDA review panel - the closest regulatory comparables to K100734.
Vinyl Co-Polymer Powder Free Examination Gloves
K142409 · Grand Work Plastic Products Co., Ltd. · Dec 2014
GRAND WORK PLASTIC PRODUCTS CO., LTD. POWDER FREE VINYL PATIENT EXAMINATION GLOVES
K102089 · Grand Work Plastic Products Co., Ltd. · Oct 2010
POWDER FREE VINYL PATIENT EXAMINATION GLOVES
K102094 · Grand Work Plastic Products Co., Ltd. · Oct 2010
VINYL CO-POLYMER POWDER FREE EXAMINATION GLOVES, BLUE COLOR
K061562 · Grand Work Plastic Products Co., Ltd. · Jul 2006
ESTEEM STRETCHY VINYL GLOVE WITH COATING
K052568 · Cardinalhealth · Nov 2005
POWDER-FREE SYNTHETIC VINYL EXAM GLOVES WITH VITAMIN E COATING
K051683 · Shen Wei (Usa), Inc. · Aug 2005