Submission Details
| 510(k) Number | K190080 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | January 16, 2019 |
| Decision Date | June 27, 2019 |
| Days to Decision | 162 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
Cleared
Traditional
Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim (Black)
Jun 2019
Decision
162d
Days
Class 1
Risk
About This 510(k) Submission
K190080 is an FDA 510(k) clearance for the Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim (Black), a Polymer Patient Examination Glove (Class I — General Controls, product code LZA), submitted by Comfort Rubber Gloves Industries Sdn. Bhd. (Matang, MY). The FDA issued a Cleared decision on June 27, 2019, 162 days after receiving the submission on January 16, 2019. 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 Comfort Rubber Gloves...
View all
K250069
· LYY · Apr 2025
K240269
· LZA · Oct 2024
K241528
· LZA · Aug 2024
K192954
· LZA · Jun 2020
K200181
· LZA · Apr 2020