Cleared Traditional

K072400 - NON-STERILE, POWDER-FREE, BLACK NITRILE EXAMINATION GLOVES

K072400 is an FDA 510(k) clearance for NON-STERILE, manufactured by Sgmp Co., Ltd.. The device is a Class 1 General Hospital device with product code LZA cleared through the Traditional 510(k) pathway after a 213-day FDA review.

K072400 · Sgmp Co., Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2008
Decision
213d
Days
Class 1
Risk

K072400 is an FDA 510(k) clearance for the NON-STERILE, POWDER-FREE, BLACK NITRILE EXAMINATION GLOVES. Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Sgmp Co., Ltd. (Sparks, US). The FDA issued a Cleared decision on March 27, 2008 after a review of 213 days - an extended review 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: 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 Sgmp Co., Ltd. devices

FDA 510(k) Submission Details - K072400

510(k) Number K072400 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 27, 2007
Decision Date March 27, 2008
Days to Decision 213 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 slower than avg
Panel avg: 129d · This submission: 213d
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 1056
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K072400.
POWDER FREE NITRILE EXAMINATION GLOVE, ORANGE
K080937 · Gx Corporation Sdn Bhd · May 2008
SMART SAVERS POWDER FREE NITRILE EXAMINATION GLOVE (BLUE, WHITE, PINK AND GRAY)
K080165 · Platinum Glove Industries Sdn. Bhd. · May 2008
NON STERILE, POWDER FREE NITRILE EXAMINATION GLOVE, BLUE, POLYMER COATING WITH CHEMOTHERAPY CLAIM
K080520 · Siam Sempermed Corp., Ltd. · Apr 2008
VFLEX POWDER FREE NITRILE EXAMINATION GLOVE (BLUE, WHITE, PINK, AND GRAY COLOR)
K080066 · Gx Corporation Sdn Bhd · Mar 2008
CHLORINATED POWDER FREE NITRILE LATEX EXAMINATION GLOVES
K071740 · Medtexx Manufacturing Sdn. Bhd. · Oct 2007
POWDER FREE NITRILE EXAMINATION GLOVES, MAGENTA AND WHITE COLOR COATED WITH ALLOGEL
K071170 · Smart Glove Corp. Sdn Bhd · Sep 2007