Cleared Traditional

K093798 - POWDER FREE VINYL PATIENT EXAMINATION GLOVE

K093798 is an FDA 510(k) clearance for POWDER FREE VINYL PATIENT EXAMINATION GLOVE, manufactured by Supermax 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 75-day FDA review.

K093798 · Supermax 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 2010
Decision
75d
Days
Class 1
Risk

K093798 is an FDA 510(k) clearance for the POWDER FREE VINYL PATIENT EXAMINATION GLOVE. Classified as Vinyl Patient Examination Glove (product code LYZ), Class I - General Controls.

Submitted by Supermax Plastic Products Co., Ltd. (Chino, US). The FDA issued a Cleared decision on February 23, 2010 after a review of 75 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 - K093798

510(k) Number K093798 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 10, 2009
Decision Date February 23, 2010
Days to Decision 75 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
54d faster than avg
Panel avg: 129d · This submission: 75d
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 716
Devices cleared under the same product code (LYZ) and FDA review panel - the closest regulatory comparables to K093798.
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, COLORED (YELLOW)
K100074 · Tangshan Jiteng Plastic Products Co., Ltd. · Feb 2010
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, COLORED (WHITE)
K100075 · Tangshan Jiteng Plastic Products Co., Ltd. · Feb 2010
POWDER FREE VINYL PATIENT EXAMINATION GLOVES (YELLOW, WHITE)
K093797 · Supermax Plastic Products Co., Ltd. · Feb 2010
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, LIGHT YELLO COLOR
K093727 · Zibo Bolin Gloves Co., Ltd. · Feb 2010
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
K093439 · Tangshan Pufa Plastic Products Co., Ltd. · Dec 2009
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
K092966 · Jin Zhou Chang Hao Plastic Products Co., Ltd. · Dec 2009