Cleared Traditional

K211073 - Disposable Nitrile Examination Gloves

K211073 is an FDA 510(k) clearance for Disposable Nitrile Examination Gloves, manufactured by Foshan Kangkang Biotechnology Co., Ltd.. The device is a Class 1 General Hospital device with product code LZA cleared through the Traditional 510(k) pathway after a 162-day FDA review.

K211073 · Foshan Kangkang Biotechnology Co., Ltd. · General Hospital
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Sep 2021
Decision
162d
Days
Class 1
Risk

K211073 is an FDA 510(k) clearance for the Disposable Nitrile Examination Gloves. Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Foshan Kangkang Biotechnology Co., Ltd. (Foshan City, CN). The FDA issued a Cleared decision on September 21, 2021 after a review of 162 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 Foshan Kangkang Biotechnology Co., Ltd. devices

FDA 510(k) Submission Details - K211073

510(k) Number K211073 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 12, 2021
Decision Date September 21, 2021
Days to Decision 162 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
33d slower than avg
Panel avg: 129d · This submission: 162d
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 687
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K211073.
ZinRom Nitrile examination gloves
K211719 · Changzhou Xingrong Medical Technology Co., Ltd. · Oct 2021
Nitrile Powder Free Examination Gloves,Tested For Use With Chemotherapy Drugs
K212036 · Jiangsu Yanfang Medical Technology Co., Ltd. · Oct 2021
Disposable Nitrile Gloves
K211781 · Jiangsu Jinke Protective Equipment Co., Ltd. · Sep 2021
Blue Nitrile Examination Glove Powder Free
K211479 · Aspen Glove Sdn. Bhd. · Sep 2021
Disposable Nitrile Gloves
K212009 · Jiangsu Shenglijie Safety Products Co., Ltd. · Sep 2021
Nitrile Examination Gloves Powder Free (Blue)
K210868 · Great Eco Glove Sdn. Bhd. · Sep 2021