Cleared Traditional

Powder Free White, Black, and Purple Nitrile Examination Glove (K231439) - FDA 510(k) Clearance

Class I General Hospital device.

K231439 · S&S Glove Corporation · General Hospital
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Aug 2023
Decision
86d
Days
Class 1
Risk

K231439 is an FDA 510(k) clearance for the Powder Free White, Black, and Purple Nitrile Examination Glove. Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by S&S Glove Corporation (Ba Ria-Vung Tau, VN). The FDA issued a Cleared decision on August 11, 2023 after a review of 86 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 S&S Glove Corporation devices

Submission Details

510(k) Number K231439 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 17, 2023
Decision Date August 11, 2023
Days to Decision 86 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
43d faster than avg
Panel avg: 129d · This submission: 86d
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 K231439.
Nitrile Patient Examination Gloves, Powder Free, Pink Color
K222103 · Shandong Yinghng Medical Products Co., Ltd. · Aug 2023
Sterile Powder Free Nitrile Examination Gloves (Blue, Black &White Colors)
K230314 · New Era Medicare Sdn. Bhd. · Aug 2023
Basic Synguard Nitrile Exam Gloves, Powder Free, Blue Colored, Non-Sterile
K231408 · Shandong Intco Medical Products Co, Ltd. · Aug 2023
Sterile Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
K232039 · Grand Work Plastic Products Co., Ltd. · Aug 2023
Disposable Medical Examination Nitrile Gloves
K232008 · Raxwell Industrial, LLC · Aug 2023
Powder Free Nitrile Examination Glove (Grey) Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
K223713 · Better Care Plastic Technology Co., Ltd. · Aug 2023