Halyard Pink Underguard Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy Drugs— 510(k) K183132
Substantially EquivalentO&M Halyard, Inc.
FDA 510(k) clearance K183132 for Halyard Pink Underguard Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy Drugs, Substantially Equivalent on 2019-02-05. Applicant: O&M Halyard, Inc.. Device class: 1.
Clearance details
- Applicant
- O&M Halyard, Inc.
- Product code
- Code LZC
- Device class
- Class 1
- Regulation
- 21 CFR 880.6250
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Location
- Alpharetta, GA, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.