Cleared Traditional

K211457 - Powder Free Nitrile Examination Gloves ...

K211457 is an FDA 510(k) clearance for Powder Free Nitrile Examination Gloves ..., manufactured by Ammex Corporation. The device is a Class 1 General Hospital device with product code LZA cleared through the Traditional 510(k) pathway after a 221-day FDA review.

K211457 · Ammex Corporation · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2021
Decision
221d
Days
Class 1
Risk

K211457 is an FDA 510(k) clearance for the Powder Free Nitrile Examination Gloves (Blue, Black, Indigo). Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Ammex Corporation (Kent, US). The FDA issued a Cleared decision on December 18, 2021 after a review of 221 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 Ammex Corporation devices

FDA 510(k) Submission Details - K211457

510(k) Number K211457 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 11, 2021
Decision Date December 18, 2021
Days to Decision 221 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
92d slower than avg
Panel avg: 129d · This submission: 221d
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 682
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K211457.
Blue Non Sterile Powder Free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs, with Gastric Acid and Fentanyl Permeation Resistance Claims.
K211022 · Central Medicare Sdn Bhd · Dec 2021
Glovmaster Nitrile Examination Glove Powder Free
K212914 · Glovmaster Sdn. Bhd. · Dec 2021
Powder Free Nitrile Examination Gloves, Non-sterile,Tested For Use with Chemotherapy Drugs and Opioid Fentanyl Citrate (Blue)
K212613 · Koon Seng Sdn Bhd · Dec 2021
USA Gloves Nitrile Powder Free Exam Gloves
K211624 · Usa Gloves · Dec 2021
Nitrile Patient Examination Gloves (Tested for Use with Chemotherapy Drugs)
K213048 · Huayuan Medical Technology(Shangqiu) Co., Ltd. · Dec 2021
Nitrile Patient Examination Gloves (Tested for Use with Chemotherapy Drugs)
K213051 · Yunnan Huazhiyuan Medical Technology Co., Ltd. · Dec 2021