Cleared Traditional

Nitrile Two Toned Blue/Green, Powder-Free, Non-sterile, Ambidextrous, Beaded Cuff, Medical Grade Exam Gloves, Tested for Use with the Opioids Fentanyl citrate, Heroin, and both Opioids in simulated Gastric Acid (Vomit) (K220371) - FDA 510(k) Clearance

Class I General Hospital device.

K220371 · Summit Glove, Inc. · General Hospital
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Nov 2022
Decision
266d
Days
Class 1
Risk

K220371 is an FDA 510(k) clearance for the Nitrile Two Toned Blue/Green, Powder-Free, Non-sterile, Ambidextrous, Beaded .... Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Summit Glove, Inc. (Minerva, US). The FDA issued a Cleared decision on November 2, 2022 after a review of 266 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 Summit Glove, Inc. devices

Submission Details

510(k) Number K220371 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 09, 2022
Decision Date November 02, 2022
Days to Decision 266 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
137d slower than avg
Panel avg: 129d · This submission: 266d
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 Consultant

Truscott Medsci Associates, LLC
Wava Truscott

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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 K220371.
Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Blue)
K222225 · Hartalega NGC Sdn. Bhd. · Nov 2022
SafeSource Direct Blue Powder-Free Nitrile Exam Gloves
K222898 · Safesource Direct, LLC · Nov 2022
Brightway Brand, Nitrile Examination Gloves, Powder Free (Blue) Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
K211816 · Brightway Holdings Sdn. Bhd. · Nov 2022
Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
K223320 · Lingshi Hongruida Health Protection Technology Co., Ltd. · Nov 2022
Medical Examination Gloves (Nitrile) (XS, S, M, L, XL)
K222498 · Humanwell Healthcare Group Medical Supplies Co., Ltd. · Oct 2022
Nitrile Examination Gloves Powder Free (Tested for use with Chemotherapy Drugs)
K223235 · Pt. Sintong Unigolden Glove · Oct 2022