Cleared Traditional

Nitrile Powder Free Blue Patient Examination Gloves Non-Sterile, Tested For Use With Chemotherapy Drugs (K214110) - FDA 510(k) Clearance

Class I General Hospital device.

K214110 · Mah Sing Healthcare Sdn. Bhd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2022
Decision
52d
Days
Class 1
Risk

K214110 is an FDA 510(k) clearance for the Nitrile Powder Free Blue Patient Examination Gloves Non-Sterile, Tested For U.... Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Mah Sing Healthcare Sdn. Bhd. (Kuala Lumpur, MY). The FDA issued a Cleared decision on February 19, 2022 after a review of 52 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Mah Sing Healthcare Sdn. Bhd. devices

Submission Details

510(k) Number K214110 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 29, 2021
Decision Date February 19, 2022
Days to Decision 52 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
77d faster than avg
Panel avg: 129d · This submission: 52d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 489
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K214110.
EONS Nitrile Examination Gloves Powder Free
K213286 · Eons Gloves (Thailand) Co., Ltd. · Feb 2022
Medical nitrile examination gloves (Model: SH001)
K213600 · Jiangxi Sanhao Medical Instruments Co.,Ltd · Feb 2022
Disposable Medical Nitrile Examination Gloves
K213912 · Jiangsu Maolin Medical Technology Co., Ltd. · Feb 2022
Powder Free Nitrile Examination Gloves, Blue,Test For Use With Chemotherapy Drugs
K213306 · Zibo Sinocare Plastic Products Co., Ltd. · Feb 2022
Powder Free Nitrile Examination Gloves (Blue, Purple-Blue), Tested for Use with Chemotherapy Drugs
K213440 · Luliang Hongruida Health Protection Technology Co., Ltd. · Feb 2022
Nitrile Examination Gloves (Model: ZMG1351)
K213688 · Wuhan Zonsen Medical Products Co., Ltd. · Feb 2022