Cleared Traditional

Powder Free Nitrile Examination Gloves (Blue, White and Black), Tested For Use With Chemotherapy Drugs and Fentanyl (K222815) - FDA 510(k) Clearance

Class I General Hospital device.

K222815 · Zibo Lanhua Medical Packaging Material Co., Ltd. · General Hospital
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Dec 2022
Decision
76d
Days
Class 1
Risk

K222815 is an FDA 510(k) clearance for the Powder Free Nitrile Examination Gloves (Blue, White and Black), Tested For Us.... Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Zibo Lanhua Medical Packaging Material Co., Ltd. (Zibo, CN). The FDA issued a Cleared decision on December 4, 2022 after a review of 76 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 Zibo Lanhua Medical Packaging Material Co., Ltd. devices

Submission Details

510(k) Number K222815 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 19, 2022
Decision Date December 04, 2022
Days to Decision 76 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
53d faster than avg
Panel avg: 129d · This submission: 76d
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 K222815.
Disposable Nitrile Examination Glove (Tested for use with Chemotherapy Drug)
K222733 · Inner Mongolia Boming Medical Supplies Co., Ltd. · Dec 2022
Jr Medic Blue Nitrile Examination Gloves Powder Free tested for use with Chemotherapy drugs and Fentanyl Citrate
K221626 · Jr Engineering & Medical Technologies (M) Sdn. Bhd. · Dec 2022
Disposable Nitrile Examination Glove
K223281 · Anhui Kindguard Medical Supplies Technology Co., Ltd. · Dec 2022
Disposable Nitrile Examination Gloves
K223004 · Jiangxi Handspro Products Solutions Co., Ltd. · Dec 2022
White Nitrile Powder Free Patient Examination Glove, Non Sterile
K222713 · Safeskin Retailing (Hk) Limited · Dec 2022
Black Nitrile Powder Free Patient Examination Glove, Non Sterile
K222715 · Safeskin Retailing (Hk) Limited · Dec 2022