Cleared Abbreviated

K121549 - NON-STERILE, POWDER-FREE NITRILE EXAMINATION GLOVE, BLUE

K121549 is an FDA 510(k) clearance for NON-STERILE, manufactured by Siam Sempermed Corp., Ltd.. The device is a Class 1 General Hospital device with product code LZA cleared through the Abbreviated 510(k) pathway after a 216-day FDA review.

K121549 · Siam Sempermed Corp., Ltd. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2012
Decision
216d
Days
Class 1
Risk

K121549 is an FDA 510(k) clearance for the NON-STERILE, POWDER-FREE NITRILE EXAMINATION GLOVE, BLUE. Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Siam Sempermed Corp., Ltd. (Clearwater, US). The FDA issued a Cleared decision on December 27, 2012 after a review of 216 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

FDA 510(k) Submission Details - K121549

510(k) Number K121549 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 25, 2012
Decision Date December 27, 2012
Days to Decision 216 days
Submission Type Abbreviated
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
87d slower than avg
Panel avg: 129d · This submission: 216d
Pathway characteristics
Standards-based clearance path.

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 K121549.
POWDER FREE BLUE NITRILE EXAMINATION GLOVE TESTED WITH CHEMOTHERAPY DRUGS
K121592 · Tekmedic (M) Sdn Bhd · Jan 2013
POWDER FREE NITRILE EXAMINATION GLOVES, BLUE AND BLACK
K123328 · Nitrilist Gloves Manufacturing Sdn Bhd · Jan 2013
POWDER FREE NITRILE EXAMINATION GLOVES (BLACK, WHITE, GREEN)
K122408 · Hongye Plastic Products Co., Ltd. · Jan 2013
POWDERED NITRILE EXAMINATION GLOVES, BLUE AND WHITE
K122874 · Nitrilist Gloves Manufacturing Sdn Bhd · Dec 2012
POWDER FREE NITRILE EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGS
K122999 · Top Glove Sdn. Bhd. · Nov 2012
POWDER FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE, WHITE AND GREEN COLORED. NON-STERILE, LOW DERMATITIS POTENTIAL
K120066 · Kossan Latex Industries(M)Sdn Bhd · Nov 2012
K121549 · NON-STERILE, POWDER-FREE NITRILE EXAMINATION GLOVE, BLUE
Download PDF FDA Summary Siam Sempermed Corp.,…