Cleared Traditional

K090336 - SUNMAX ENTERPRISE SHANGHAI CO. POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVE TESTED WITH CHEMOTHERAPY DRUGS

K090336 is an FDA 510(k) clearance for SUNMAX ENTERPRISE SHANGHAI CO. POWDER F..., manufactured by Sunmax Enterprise Shanghai Co. , Ltd.. The device is a Class 1 General Hospital device with product code LZA cleared through the Traditional 510(k) pathway after a 141-day FDA review.

K090336 · Sunmax Enterprise Shanghai Co. , Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2009
Decision
141d
Days
Class 1
Risk

K090336 is an FDA 510(k) clearance for the SUNMAX ENTERPRISE SHANGHAI CO. POWDER FREE BLUE NITRILE PATIENT EXAMINATION G.... Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Sunmax Enterprise Shanghai Co. , Ltd. (Great Neck, US). The FDA issued a Cleared decision on July 1, 2009 after a review of 141 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.

View all Sunmax Enterprise Shanghai Co. , Ltd. devices

FDA 510(k) Submission Details - K090336

510(k) Number K090336 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 10, 2009
Decision Date July 01, 2009
Days to Decision 141 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
12d slower than avg
Panel avg: 129d · This submission: 141d
Pathway characteristics
Predicate-based equivalence.

LZA Device Classification - Class 1, General Controls

Product Code LZA Polymer Patient Examination Glove
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6250
Definition A Nitrile (or Polymer) Patient Examination Glove Is A Disposable Device Made Of Nitrile Rubber Or Synthetic Polymers 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 - LZA Polymer Patient Examination Glove

All 778
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K090336.
NITRILE POWDER FRE EXAMINATION GLOVES (BLUE) TESTED FOR USE WITH CHEMOTHREAPY DRUGS
K091652 · Hartalega Sdn Bhd · Sep 2009
POWDER FREE NITRILE EXAMINATION GLOVE (BLUE)
K091147 · Smart Glove Corp. Sdn Bhd · Jul 2009
POWDER- FREE NITRILE EXAMINATION GLOVES, BLACK COLOR
K090194 · Shen Wei (Usa), Inc. · Jul 2009
POWDER FREE NITRILE EXAMINATION GLOVES (PINK, GREEN, ORANGE,WHITE).
K090412 · Gx Corporation Sdn Bhd · Jun 2009
POWDER FREE NITRILE EXAMINATION GLOVE, GREEN TEA SCENTED, GREEN
K091151 · Gx Corporation Sdn Bhd · Jun 2009
NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVE, BLUE COLOR, POLYMER COATED, TESTED WITH CHEMOTHERAPY DRUGS
K082957 · Siam Sempermed Corp., Ltd. · May 2009