Cleared Traditional

K211003 - SHOWA Blue Nitrile Powder Free Medical ...

K211003 is an FDA 510(k) clearance for SHOWA Blue Nitrile Powder Free Medical ..., manufactured by Showa Best Glove, Inc.. The device is a Class 1 General Hospital device with product code LZA cleared through the Traditional 510(k) pathway after a 292-day FDA review.

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

FDA 510(k) Submission Details - K211003

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.

LZA Device Classification - Class 1, General Controls

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 684
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