Cleared Traditional

K172678 - THERMOPLASTIC ELASTOMER EXAMINATION (TPE) GLOVE

K172678 is an FDA 510(k) clearance for THERMOPLASTIC ELASTOMER EXAMINATION (TP..., 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 80-day FDA review.

K172678 · Shen Wei (Usa), Inc. · General Hospital
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Nov 2017
Decision
80d
Days
Class 1
Risk

K172678 is an FDA 510(k) clearance for the 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 November 24, 2017 after a review of 80 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

FDA 510(k) Submission Details - K172678

510(k) Number K172678 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 05, 2017
Decision Date November 24, 2017
Days to Decision 80 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
49d faster than avg
Panel avg: 129d · This submission: 80d
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 1019
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K172678.
U-MED Powder Free Polyethylene Examination Gloves,Blue Color
K173228 · Jiangsu U-Med Rubber & Plastic Products Co., Ltd. · Feb 2018
Micro Touch Denta Glove Nitrile Hydrasoft Patient Examination Gloves
K171737 · Ansell Healthcare Products, LLC · Dec 2017
Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Pink)
K173137 · Hartalega Sdn Bhd · Dec 2017
Powder Free Pink Polychloroprene Copolymer Examination Gloves, Powder Free Black Polychloroprene Copolymer Examination Gloves
K171743 · Smart Glove Corporation Sdn. Bhd. · Nov 2017
Powder Free Nitrile Patient Examination Glove, Blue Colored, Non Sterile, Tested for Use with Chemotherapy Drugs
K171873 · Zhonghong Pulin Medical Products Co., Ltd. · Nov 2017
Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs (Blue)
K172442 · Hartalega NGC Sdn. Bhd. · Nov 2017