Submission Details
| 510(k) Number | K183132 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 13, 2018 |
| Decision Date | February 05, 2019 |
| Days to Decision | 84 days |
| Submission Type | Abbreviated |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
Cleared
Abbreviated
Halyard Pink Underguard Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy Drugs
Feb 2019
Decision
84d
Days
Class 1
Risk
About This 510(k) Submission
K183132 is an FDA 510(k) clearance for the Halyard Pink Underguard Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy Drugs, a Medical Glove, Specialty (Class I — General Controls, product code LZC), submitted by O&M Halyard, Inc. (Alpharetta, US). The FDA issued a Cleared decision on February 5, 2019, 84 days after receiving the submission on November 13, 2018. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6250.
Device Classification
| Product Code | LZC — Medical Glove, Specialty |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 880.6250 |
| Definition | A Disposable Medical Glove (examination Or Surgeon?s) Is A Device That May Or May Not Bear A Trace Amount Of Residual Powder And Is Intended To Be Worn On The Hand Or Finger(s) For Medical Purposes To Prevent Contamination. In Addition, These Gloves May Have Specialty Claims Such As Chemotherapy, Etc. |
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