Submission Details
| 510(k) Number | K211390 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | May 05, 2021 |
| Decision Date | August 28, 2021 |
| Days to Decision | 115 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
Cleared
Traditional
Nitrile Blue Powder-free Examination Glove
Aug 2021
Decision
115d
Days
Class 1
Risk
About This 510(k) Submission
K211390 is an FDA 510(k) clearance for the Nitrile Blue Powder-free Examination Glove, a Polymer Patient Examination Glove (Class I — General Controls, product code LZA), submitted by Cardinal Health200, LLC (Waukegan, US). The FDA issued a Cleared decision on August 28, 2021, 115 days after receiving the submission on May 5, 2021. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6250.
Device Classification
| Product Code | LZA — Polymer Patient Examination Glove |
| Device Class | Class I — 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. |
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