Cleared Traditional

Nitrile Patient Examination Gloves Blue Tested For Use With Chemotherapy Drugs, Nitrile Patient Examination Gloves Blue Violet Tested For Use With Chemotherapy Drugs (K211220) - FDA 510(k) Clearance

Class I General Hospital device.

K211220 · Guangdong Kingfa Sci. & Tech.Co., Ltd. · General Hospital
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Jul 2021
Decision
90d
Days
Class 1
Risk

K211220 is an FDA 510(k) clearance for the Nitrile Patient Examination Gloves Blue Tested For Use With Chemotherapy Drug.... Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Guangdong Kingfa Sci. & Tech.Co., Ltd. (Qingyuan, CN). The FDA issued a Cleared decision on July 22, 2021 after a review of 90 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.

View all Guangdong Kingfa Sci. & Tech.Co., Ltd. devices

Submission Details

510(k) Number K211220 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 23, 2021
Decision Date July 22, 2021
Days to Decision 90 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
39d faster than avg
Panel avg: 129d · This submission: 90d
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 K211220.
Blue Nitrile Exam Gloves
K211341 · Jiangxi Surefine Medical Co., Ltd. · Jul 2021
Powder Free Nitrile Examination Gloves with Aloe Vera, Orange and Orange-White Colors
K211455 · Shen Wei (Usa), Inc. · Jul 2021
Nitrile Patient Examination Gloves
K211012 · Huayuan Medical Technology(Shangqiu) Co., Ltd. · Jul 2021
Nitrile Patient Examination Glove
K210686 · Yunnan Huazhiyuan Medical Technology Co., Ltd. · Jul 2021
Disposable Nitrile Medical Examination Glove
K210684 · Jiangsu Cureguard Glove Co., Ltd. · Jul 2021
Edma Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs)
K211547 · Edma Group, LLC · Jul 2021