Cleared Abbreviated

Halyard Sterling* Nitrile Powder-Free Exam Gloves, Halyard Sterling SG* Nitrile Sensi-Guard Powder-Free Exam Gloves

K191230 · O&M Halyard, Inc. · General Hospital
Nov 2019
Decision
184d
Days
Class 1
Risk

About This 510(k) Submission

K191230 is an FDA 510(k) clearance for the Halyard Sterling* Nitrile Powder-Free Exam Gloves, Halyard Sterling SG* Nitrile Sensi-Guard Powder-Free Exam Gloves, a Medical Glove, Specialty (Class I — General Controls, product code LZC), submitted by O&M Halyard, Inc. (Mechanicsville, US). The FDA issued a Cleared decision on November 8, 2019, 184 days after receiving the submission on May 8, 2019. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6250.

Submission Details

510(k) Number K191230 FDA.gov
FDA Decision Cleared SESE
Date Received May 08, 2019
Decision Date November 08, 2019
Days to Decision 184 days
Submission Type Abbreviated
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code LZC — Medical Glove, Specialty
Device Class Class I — General Controls
CFR Regulation 21 CFR 880.6250
Definition A Disposable Medical Glove (examination Or Surgeon?s) Is A Device That May Or May Not Bear A Trace Amount Of Residual Powder And Is Intended To Be Worn On The Hand Or Finger(s) For Medical Purposes To Prevent Contamination. In Addition, These Gloves May Have Specialty Claims Such As Chemotherapy, Etc.

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