Cleared Traditional

Nitrile Medical Examination Gloves (K221108) - FDA 510(k) Clearance

Class I General Hospital device.

K221108 · Anhui Fulewei Electronic Technology Co.,Ltd · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2022
Decision
88d
Days
Class 1
Risk

K221108 is an FDA 510(k) clearance for the Nitrile Medical Examination Gloves. Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Anhui Fulewei Electronic Technology Co.,Ltd (Fuyang, CN). The FDA issued a Cleared decision on July 12, 2022 after a review of 88 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 Anhui Fulewei Electronic Technology Co.,Ltd devices

Submission Details

510(k) Number K221108 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 15, 2022
Decision Date July 12, 2022
Days to Decision 88 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
41d faster than avg
Panel avg: 129d · This submission: 88d
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 K221108.
Dual Color Blue/White Powder Free Nitrile Examination Glove with Chemotherapy Drug and Fentanyl Test Claim
K220943 · Eco Medi Glove Sdn. Bhd. · Jul 2022
Powder Free Nitrile Examination Gloves, (Cobalt Blue and Violet Blue), Powder Free Latex Examination Gloves
K221229 · Zibo Blue Sail Health Technology Co., Ltd. · Jul 2022
Nitrile Vinyl Blend Powder Free Examination Gloves (Black)
K213574 · Grand Work Plastic Products Co., Ltd. · Jul 2022
Disposable Medical Nitrile Examination Gloves - Non Sterile
K221454 · Guangzhou Kangling Biotechnology Co., Ltd. · Jul 2022
Powder Free Nitrile Examination Gloves (Blue)
K220284 · Kgm Gloves Sdn. Bhd. · Jul 2022
Sapphire Pro Powder-Free Royal Blue Nitrile Exam Gloves
K220825 · American Nitrile Operations, LLC · Jul 2022