Cleared Traditional

K202078 - Biodegradable Thermoplastic Elastomer Examination (TPE) Glove

K202078 is an FDA 510(k) clearance for Biodegradable Thermoplastic Elastomer E..., manufactured by Shen Wei (Usa), Inc.. The device is a Class 1 General Hospital device with product code LZA cleared through the Traditional 510(k) pathway after a 221-day FDA review.

K202078 · Shen Wei (Usa), Inc. · General Hospital
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Mar 2021
Decision
221d
Days
Class 1
Risk

K202078 is an FDA 510(k) clearance for the Biodegradable Thermoplastic Elastomer Examination (TPE) Glove. 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 5, 2021 after a review of 221 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.

FDA 510(k) Submission Details - K202078

510(k) Number K202078 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 27, 2020
Decision Date March 05, 2021
Days to Decision 221 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
92d slower than avg
Panel avg: 129d · This submission: 221d
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 1181
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K202078.
Biodegradable Powder Free Nitrile Examination Glove, Green-White and Orange-White Colors with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Simulated Gastric Acid
K202082 · Shen Wei (Usa), Inc. · Mar 2021
Biodegradable Powder Free Nitrile Examination Glove, Low Dermatitis,Potential Claim, Blue, Green, Black, White, Orange, Black-White, Teal-Gray, White-Green, White-Orange, White-Blue, Blue-White, Green-White, Orange-White Colors
K202086 · Shen Wei (Usa), Inc. · Mar 2021
Biodegradable Powder Free Flock-Lined Nitrile Examination Glove, Black and Gray Colors
K202076 · Shen Wei (Usa), Inc. · Mar 2021
Powder free Nitrile Examination Gloves (Blue, Violet Blue, White, Cobalt Blue)
K202356 · Kanglongda Vietnam Protection Technology Company Limited · Mar 2021
Nitrile Examination Gloves (Blue, Violet Blue, White)
K202402 · Jiangsu Tianshuo Medical Products Co., Ltd. · Mar 2021
Nitrile Powder Free Examination Glove, Blue Tested for Use with 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim
K202003 · Gmp Medicare Sdn. Bhd. · Feb 2021
K202078 · Biodegradable Thermoplastic Elastomer Examination (TPE) Glove
Download PDF Shen Wei (Usa), Inc.