Cleared Traditional

K202080 - Biodegradable Powder Free Nitroprene Examination Glove, Low Dermatitis Potential Claim, Teal-Black Color

K202080 is an FDA 510(k) clearance for Biodegradable Powder Free Nitroprene Ex..., 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 240-day FDA review.

K202080 · Shen Wei (Usa), Inc. · General Hospital
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Mar 2021
Decision
240d
Days
Class 1
Risk

K202080 is an FDA 510(k) clearance for the Biodegradable Powder Free Nitroprene Examination Glove, Low Dermatitis Potent.... 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 24, 2021 after a review of 240 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

FDA 510(k) Submission Details - K202080

510(k) Number K202080 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 27, 2020
Decision Date March 24, 2021
Days to Decision 240 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
111d slower than avg
Panel avg: 129d · This submission: 240d
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 1020
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K202080.
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 Nitrile Examination Glove, Blue-White Color with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs
K202083 · 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
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