Cleared Traditional

SHOWA(R) Blue Nitrile Powder Free Medical Examination Glove (K211003) - FDA 510(k) Clearance

Class I General Hospital device.

K211003 · Showa Best Glove, Inc. · General Hospital
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Jan 2022
Decision
292d
Days
Class 1
Risk

K211003 is an FDA 510(k) clearance for the SHOWA(R) Blue Nitrile Powder Free Medical Examination Glove. Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Showa Best Glove, Inc. (Menlo, US). The FDA issued a Cleared decision on January 19, 2022 after a review of 292 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 Showa Best Glove, Inc. devices

Submission Details

510(k) Number K211003 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 02, 2021
Decision Date January 19, 2022
Days to Decision 292 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
163d slower than avg
Panel avg: 129d · This submission: 292d
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 K211003.
Powder Free Nitrile Patient Examination Gloves, Blue Color
K211864 · Siyang Jaysun Medtech Co., Ltd. · Jan 2022
Nitrile Examination Gloves
K213044 · Jiangsu Huayuan Medical Technology Co., Ltd. · Jan 2022
Goody Gloves, Wincare, TBG Gloves
K213075 · Thai Rubber Gloves Co., Ltd. · Jan 2022
Powder free Nitrile Examination Glove-(Test for use with Chemotherapy Drugs)
K213227 · Uweport, LLC · Jan 2022
Disposable Nitrile Powder Free Examination Gloves (Non-sterile)
K211360 · Pt. Universal Gloves · Jan 2022
Stronghold Group Nitrile Examination Glove, Powder Free
K213859 · Stronghold Group, LLC · Jan 2022