Cleared Traditional

K202083 - Biodegradable Powder Free Nitrile Exami...

K202083 is the FDA 510(k) clearance for Biodegradable Powder Free Nitrile Exami... 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 241-day FDA review.

K202083 · Shen Wei (Usa), Inc. · General Hospital
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Mar 2021
Decision
241d
Days
Class 1
Risk

K202083 is an FDA 510(k) clearance for the Biodegradable Powder Free Nitrile Examination Glove, Blue-White Color with Lo.... 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 March 25, 2021 after a review of 241 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 Shen Wei (Usa), Inc. devices

Submission Details

510(k) Number K202083 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 27, 2020
Decision Date March 25, 2021
Days to Decision 241 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
112d slower than avg
Panel avg: 129d · This submission: 241d
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 K202083.
Nitrile Examination Gloves
K210106 · Zhenjiang Huayang Latex Products Co., Ltd. · Apr 2021
Blue Nitrile Exam Glove, Powder Free
K210057 · Real Star Medical Technology Co., Ltd. · Mar 2021
Blue Nitrile Exam Glove, Powder Free
K210058 · Great Harvest Trading Co., Ltd. · Mar 2021
Biodegradable Powder Free Nitroprene Examination Glove, Low Dermatitis Potential Claim, Teal-Black Color
K202080 · Shen Wei (Usa), Inc. · Mar 2021
Biodegradable DriTek Powder Free Nitrile Examination Glove, Low Dermatitis Potential Claim, Blue
K202081 · Shen Wei (Usa), Inc. · Mar 2021
Patient Examination Gloves
K203593 · Guangdong Kingfa Sci. & Tech.Co., Ltd. · Mar 2021