Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Halyard Pink Underguard Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy Drugs

K-Number: K183132 · 2019-02-05

ApplicantO&M Halyard, Inc.
Decision Date2019-02-05
Product CodeLZC
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Halyard Pink Underguard Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy Drugs is a medical device manufactured by O&M Halyard, Inc.. It received FDA 510(k) clearance on 2019-02-05 under approval number K183132. The device is classified under product code LZC. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Halyard Pink Underguard Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy Drugs?

Halyard Pink Underguard Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy Drugs is a medical device that received FDA 510(k) clearance on 2019-02-05. It is manufactured by O&M Halyard, Inc.. The 510(k) number is K183132.

When was Halyard Pink Underguard Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy Drugs approved by the FDA?

Halyard Pink Underguard Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy Drugs received FDA 510(k) clearance on 2019-02-05, under approval number K183132.

What company makes Halyard Pink Underguard Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy Drugs?

Halyard Pink Underguard Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy Drugs is manufactured by O&M Halyard, Inc..

What is the FDA product code for Halyard Pink Underguard Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy Drugs?

The FDA product code for Halyard Pink Underguard Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy Drugs is LZC.

Related Clinical Trials

NCT06577454 Measuring the Effects of Neurostimulation on Risky and Ambiguous Decision-Making Capacity in People With and Without Substance Use Disorder SUSPENDED NCT07067138 A Synthetic Lethality-Focused Algorithm to Identify Therapeutic Options in Advanced Metastatic Breast Cancer (SYNTHESIS-Breast) SUSPENDED NCT04105374 Testing the Addition of an Anti-cancer Viral Gene Therapy, Toca 511/Toca FC, to the Usual Treatment (Temozolomide and Radiation Therapy) for Newly Diagnosed Glioblastoma WITHDRAWN NCT04034251 Intraperitoneal and Intravenous Paclitaxel Chemotherapy With Oral Capecitabine for Gastric Adenocarcinoma With Peritoneal Carcinomatosis TERMINATED NCT05989750 Air-polishing With Erythritol During Orthodontic Tretament RECRUITING NCT05286814 PDS01ADC in Combination With Hepatic Artery Infusion Pump (HAIP) and Systemic Therapy for Subjects With Metastatic Colorectal Cancer, Intrahepatic Cholangiocarcinoma, or Metastatic Adrenocortical Carcinoma RECRUITING

Other Devices by O&M Halyard, Inc.

K192362Aero Blue Performance Surgical Gowns K191230Halyard Sterling* Nitrile Powder-Free Exam Gloves, Halyard Sterling SG* Nitrile Sensi-Guard Powder-Free Exam Gloves K182851SkyBreeze Zero Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy Drugs K200843Halyard Pink Underguard Zero, Sterile Powder-Free Exam Gloves Tested with Chemotherapy Drugs K200522AERO CHROME* Breathable Performance Surgical Gowns K211063HALYARD Flexaprene Green Powder-Free Exam Glove

View all 23 devices →

Related Devices (Code: LZC)

K160709HALYARD* PURPLE NITRILE – XTRA* Powder-Free Exam GlovesHalyard Health K151390Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy DrugsMaxter Glove Manufacturing Sdn Bhd K152222NITRILE BLUE POWDER FREE EXAMINATION GLOVES tested for use with Chemotheraphy DrugsGmp Medicare Sdn Bhd (F25) K172642Orange Non Sterile Powder Free Nitrile Examination GlovesCentral Medicare Sdn Bhd K172525Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy DrugsCentral Medicare Sdn Bhd K162858NITRILECARE NITRILE EXAMINATION GLOVES POWDER FREE, BLUE, CHEMOTESTCareplus (M) Sdn Bhd

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑