Cleared Traditional

K100339 - POWDER-FREE VINYL PATIENT EXAMINATION GLOVES

K100339 is an FDA 510(k) clearance for POWDER-FREE VINYL PATIENT EXAMINATION G..., manufactured by Tangshan Changrong Glove Co., Ltd.. The device is a Class 1 General Hospital device with product code LYZ cleared through the Traditional 510(k) pathway after a 45-day FDA review.

K100339 · Tangshan Changrong Glove Co., Ltd. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2010
Decision
45d
Days
Class 1
Risk

K100339 is an FDA 510(k) clearance for the POWDER-FREE VINYL PATIENT EXAMINATION GLOVES. Classified as Vinyl Patient Examination Glove (product code LYZ), Class I - General Controls.

Submitted by Tangshan Changrong Glove Co., Ltd. (Beijing, CN). The FDA issued a Cleared decision on March 22, 2010 after a review of 45 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.

FDA 510(k) Submission Details - K100339

510(k) Number K100339 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 05, 2010
Decision Date March 22, 2010
Days to Decision 45 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
84d faster than avg
Panel avg: 129d · This submission: 45d
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 750
Devices cleared under the same product code (LYZ) and FDA review panel - the closest regulatory comparables to K100339.
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
K100324 · Tangshan Hengtong Plastic Products Co. · Mar 2010
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
K100337 · Tangshan Qixin Glove Co., Ltd. · Mar 2010
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K100326 · Tangshan Hongda Plastci Products Co, Ltd. · Mar 2010
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, COLORED (YELLOW)
K100058 · Tangshan Zhongpu Plastic Products Co., Ltd. · Mar 2010
RUBBER-LIKE POWDER FREE VINYL PATIENT EXAMINATION GLOVES, WHITE COLOR
K093576 · Jiangsu Cureguard Glove Co., Ltd. · Mar 2010
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, COLORED (YELLOW)
K100074 · Tangshan Jiteng Plastic Products Co., Ltd. · Feb 2010
K100339 · POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
Download PDF FDA Summary Tangshan Changrong Gl…