Submission Details
| 510(k) Number | K211063 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | April 09, 2021 |
| Decision Date | November 19, 2021 |
| Days to Decision | 224 days |
| Submission Type | Abbreviated |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
Cleared
Abbreviated
HALYARD Flexaprene Green Powder-Free Exam Glove
Nov 2021
Decision
224d
Days
Class 1
Risk
About This 510(k) Submission
K211063 is an FDA 510(k) clearance for the HALYARD Flexaprene Green Powder-Free Exam Glove, a Polymer Patient Examination Glove (Class I — General Controls, product code LZA), submitted by O&M Halyard, Inc. (Alpharetta, US). The FDA issued a Cleared decision on November 19, 2021, 224 days after receiving the submission on April 9, 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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