Cleared Traditional

K011613 - POWDER-FREE GREEN BARRIER-PRO SYNTHETIC BUTADIENE COPOLYMER EXAMINATION GLOVE

K011613 is an FDA 510(k) clearance for POWDER-FREE GREEN BARRIER-PRO SYNTHETIC..., manufactured by Shield Gloves Manufacturer (M) Sdn Bhd. The device is a Class 1 General Hospital device with product code LZA cleared through the Traditional 510(k) pathway after a 115-day FDA review.

K011613 · Shield Gloves Manufacturer (M) Sdn Bhd · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2001
Decision
115d
Days
Class 1
Risk

K011613 is an FDA 510(k) clearance for the POWDER-FREE GREEN BARRIER-PRO SYNTHETIC BUTADIENE COPOLYMER EXAMINATION GLOVE. Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Shield Gloves Manufacturer (M) Sdn Bhd (Sparks, US). The FDA issued a Cleared decision on September 17, 2001 after a review of 115 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.

FDA 510(k) Submission Details - K011613

510(k) Number K011613 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 25, 2001
Decision Date September 17, 2001
Days to Decision 115 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
14d faster than avg
Panel avg: 129d · This submission: 115d
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 1176
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K011613.
POWDER-FREE BUTADIENE COPOLYMER EXAM GLOVES WITH ALOE, VITAMINS E PH5.5
K011961 · Shen Wei (Usa), Inc. · Sep 2001
PRE-POWDERED NITRILE EXAMINATION GLOVES
K010232 · P.T. Healthcare Glovindo · Sep 2001
GREEN NITRILE POWDER-FREE MEDICAL EXMAINATION GLOVE
K012899 · Best Manufacturing Company · Sep 2001
SUNMAX BLUE NITRILE POWDER-FREE EXAMINATION GLOVE
K011765 · Sunmax Enterprise Shanghai Co. , Ltd. · Aug 2001
POWDER FREE NEOPRENE EXAMINATION GLOVES, NON STERILE
K012048 · Wrp Asia Pacific Sdn. Bhd. · Aug 2001
SUNMAX BLUE NITRILE POWDERED EXAMINATION GLOVES
K011717 · Sunmax Enterprise Shanghai Co. , Ltd. · Aug 2001
K011613 · POWDER-FREE GREEN BARRIER-PRO SYNTHETIC BUTADIENE COPOLYMER EXAMINATION GLOVE
Download PDF FDA Summary Shield Gloves Manufac…