Cleared Traditional

K213141 - Biodegradable Powder Free Nitrile Examination Glove, Blue and Green colors, Low Dermatitis Potential, Tested for use with Chemotherapy drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl Citrate-Simulated Gastric Acid Solution

K213141 is an FDA 510(k) clearance for Biodegradable Powder Free Nitrile Exami..., 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 243-day FDA review.

K213141 · Shen Wei (Usa), Inc. · General Hospital
Download Printable Device Report (PDF)
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May 2022
Decision
243d
Days
Class 1
Risk

K213141 is an FDA 510(k) clearance for the Biodegradable Powder Free Nitrile Examination Glove, Blue and Green colors, L.... 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 May 28, 2022 after a review of 243 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 - K213141

510(k) Number K213141 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 2021
Decision Date May 28, 2022
Days to Decision 243 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
114d slower than avg
Panel avg: 129d · This submission: 243d
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 1013
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K213141.
Disposable Nitrile Powder-Free Examination Gloves (Tested for Use with Chemotherapy Drugs)
K220488 · Anhui Zhong Lian Latex Gloves Manufacturing Co., Ltd. · Jun 2022
Disposable Powder Free Polyethylene Examination Gloves
K212699 · Mastermax Plastic (Huizhou), Ltd. · May 2022
Blue Nitrile Examination Gloves Powder Free
K212584 · Amazing Rubber Products Pvt, Ltd. · May 2022
Powder-Free Nitrile Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl (White, Blue, Black, Orange and Green Color)
K220609 · Encompass Industries Sdn. Bhd. · May 2022
PP Care Nitrile Examination Gloves
K212629 · Eg Group Product and Services Co., Ltd. · May 2022
Sterile Nitrile Powder Free Examination Gloves Tested For Use With Chemotherapy Drugs And Fentanyl Citrate (Blue)
K220249 · Grand Work Plastic Products Co., Ltd. · May 2022