Cleared Traditional

K211455 - Powder Free Nitrile Examination Gloves ...

K211455 is the FDA 510(k) clearance for Powder Free Nitrile Examination Gloves ... by Shen Wei (Usa), Inc.. It is a Class 1 General Hospital device (product code LZA) cleared through the Traditional 510(k) pathway after a 79-day FDA review.

K211455 · Shen Wei (Usa), Inc. · General Hospital
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Jul 2021
Decision
79d
Days
Class 1
Risk

K211455 is an FDA 510(k) clearance for the Powder Free Nitrile Examination Gloves with Aloe Vera, Orange and Orange-Whit.... Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Shen Wei (Usa), Inc. (Union City, US). The FDA issued a Cleared decision on July 28, 2021 after a review of 79 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 Shen Wei (Usa), Inc. devices

Submission Details

510(k) Number K211455 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 10, 2021
Decision Date July 28, 2021
Days to Decision 79 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
50d faster than avg
Panel avg: 129d · This submission: 79d
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 583
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K211455.
Disposable Nitrile Examination Gloves
K211264 · Shenzhen Shiqiao Science and Technology Co., Ltd. · Jul 2021
Disposable Nitrile Medical Examination Glove
K211131 · Siyang Threeguard Medical Supplies Co., Ltd. · Jul 2021
Blue Nitrile Exam Gloves
K211341 · Jiangxi Surefine Medical Co., Ltd. · Jul 2021
Nitrile Patient Examination Gloves
K211012 · Huayuan Medical Technology(Shangqiu) Co., Ltd. · Jul 2021
Nitrile Patient Examination Gloves Blue Tested For Use With Chemotherapy Drugs, Nitrile Patient Examination Gloves Blue Violet Tested For Use With Chemotherapy Drugs
K211220 · Guangdong Kingfa Sci. & Tech.Co., Ltd. · Jul 2021
Nitrile Patient Examination Glove
K210686 · Yunnan Huazhiyuan Medical Technology Co., Ltd. · Jul 2021