Submission Details
| 510(k) Number | K200843 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 31, 2020 |
| Decision Date | September 22, 2020 |
| Days to Decision | 175 days |
| Submission Type | Abbreviated |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
Cleared
Abbreviated
Halyard Pink Underguard Zero, Sterile Powder-Free Exam Gloves Tested with Chemotherapy Drugs
Sep 2020
Decision
175d
Days
Class 1
Risk
About This 510(k) Submission
K200843 is an FDA 510(k) clearance for the Halyard Pink Underguard Zero, Sterile Powder-Free Exam Gloves Tested with Chemotherapy Drugs, a Polymer Patient Examination Glove (Class I — General Controls, product code LZA), submitted by O&M Halyard, Inc. (Mechanicsville, US). The FDA issued a Cleared decision on September 22, 2020, 175 days after receiving the submission on March 31, 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. |
Manufacturer
Similar Devices — LZA Polymer Patient Examination Glove
All 1167
K253160 · Basic Medical Technology, Inc.
· Jan 2026
K252549 · Kossan International Sdn Bhd
· Jan 2026
K251141 · Mercator Medical (Thailand), Ltd.
· Nov 2025
K250861 · Hartalega NGC Sdn. Bhd.
· Oct 2025
K252075 · Program Insite, LLC
· Oct 2025
K251716 · Basic Medical Technology, Inc.
· Aug 2025
More from O&M Halyard, Inc.
View all
K252941
· FXX · Dec 2025
K243604
· LZA · Aug 2025
K243172
· LZA · Jun 2025
K242558
· LZA · Dec 2024
K241909
· LZA · Sep 2024