Submission Details
| 510(k) Number | K200150 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | January 22, 2020 |
| Decision Date | October 26, 2020 |
| Days to Decision | 278 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
Cleared
Traditional
Medline Powder-Free Orange Nitrile Patient Examination Glove (Tested for use with Fentanyl)
Oct 2020
Decision
278d
Days
Class 1
Risk
About This 510(k) Submission
K200150 is an FDA 510(k) clearance for the Medline Powder-Free Orange Nitrile Patient Examination Glove (Tested for use with Fentanyl), a Polymer Patient Examination Glove (Class I — General Controls, product code LZA), submitted by Medline Industries, Inc. (Northfield, US). The FDA issued a Cleared decision on October 26, 2020, 278 days after receiving the submission on January 22, 2020. 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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