Cleared Traditional

K011961 - POWDER-FREE BUTADIENE COPOLYMER EXAM GLOVES WITH ALOE, VITAMINS E PH5.5

K011961 is an FDA 510(k) clearance for POWDER-FREE BUTADIENE COPOLYMER EXAM GL..., manufactured by Shen Wei (Usa), Inc.. The device is a Class 1 General Hospital device with product code LZA cleared through the Traditional 510(k) pathway after a 96-day FDA review.

K011961 · Shen Wei (Usa), Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2001
Decision
96d
Days
Class 1
Risk

K011961 is an FDA 510(k) clearance for the POWDER-FREE BUTADIENE COPOLYMER EXAM GLOVES WITH ALOE, VITAMINS E PH5.5. Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Shen Wei (Usa), Inc. (Union City, US). The FDA issued a Cleared decision on September 26, 2001 after a review of 96 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 Shen Wei (Usa), Inc. devices

FDA 510(k) Submission Details - K011961

510(k) Number K011961 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 22, 2001
Decision Date September 26, 2001
Days to Decision 96 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
33d faster than avg
Panel avg: 129d · This submission: 96d
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 1019
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K011961.
NON-STERILE POWDER FREE GREEN BARRIER-PRO SYNTHETIC BUTADIENE COPOLYMER EXAMINATION GLOVE, COLOR: BLUE
K020317 · Sgmp Co., Ltd. · Feb 2002
SMART GLOVE STERILE NITRILE EXAM GLOVE
K012853 · Smart Glove Corp. Sdn Bhd · Nov 2001
TRUE ADVANTAGE NON-STERILE POWDER FREE PURPLE NITRILE EXAMINATION GLOVE
K013016 · Tillotson Healthcare Corp. · Oct 2001
POWDER-FREE GREEN BARRIER-PRO SYNTHETIC BUTADIENE COPOLYMER EXAMINATION GLOVE
K011613 · Shield Gloves Manufacturer (M) Sdn Bhd · Sep 2001
POWDER FREE NEOPRENE EXAMINATION GLOVES, NON STERILE
K012048 · Wrp Asia Pacific Sdn. Bhd. · Aug 2001
CYMUN-NBR POWDER FREE BLUE NITRILE EXAMINATION GLOVE
K011497 · Tillotson Healthcare Corp. · Jul 2001