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

FDA 510(k)

PURE ADVANTAGE NITRILE HYPOALLERGENIC PATIENT EXAMINATION GLOVES

K-Number: K954574 · 1995-12-21

ApplicantTillotson Healthcare Corp.
Decision Date1995-12-21
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

PURE ADVANTAGE NITRILE HYPOALLERGENIC PATIENT EXAMINATION GLOVES is the device name listed in this FDA 510(k) record. The listed applicant is Tillotson Healthcare Corp.. It received FDA 510(k) clearance on 1995-12-21 under 510(k) number K954574. The device is classified under product code LZA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PURE ADVANTAGE NITRILE HYPOALLERGENIC PATIENT EXAMINATION GLOVES?

PURE ADVANTAGE NITRILE HYPOALLERGENIC PATIENT EXAMINATION GLOVES is a medical device that received FDA 510(k) clearance on 1995-12-21. The listed applicant is Tillotson Healthcare Corp.. The 510(k) number is K954574.

When did PURE ADVANTAGE NITRILE HYPOALLERGENIC PATIENT EXAMINATION GLOVES receive FDA 510(k) clearance?

PURE ADVANTAGE NITRILE HYPOALLERGENIC PATIENT EXAMINATION GLOVES received FDA 510(k) clearance on 1995-12-21, under 510(k) number K954574.

Who is the listed applicant for PURE ADVANTAGE NITRILE HYPOALLERGENIC PATIENT EXAMINATION GLOVES?

The FDA 510(k) record lists Tillotson Healthcare Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PURE ADVANTAGE NITRILE HYPOALLERGENIC PATIENT EXAMINATION GLOVES?

The FDA product code for PURE ADVANTAGE NITRILE HYPOALLERGENIC PATIENT EXAMINATION GLOVES is LZA.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Tillotson Healthcare Corp. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K021007ULTRA PRESERVE WITH ALOE VERA (GREEN) NATURAL RUBBER LATEX EXAMINATION GLOVE MADE FROM ALLOTEX AN ENZYME TREATED NATURALK013324HPI SENSI GRIP STERILE POWDERED LATEX SURGICAL GLOVE,WITH LABELED PROTEIN CONTENT AND MADE FROM ALLOTEX AN ENZYME TREATK013016TRUE ADVANTAGE NON-STERILE POWDER FREE PURPLE NITRILE EXAMINATION GLOVEK013286CYMUNVERA POWDER FREE GREEN NATURAL RUBBER LATEX PATIENT EXAMINATION GLOVE LINED WITH ALOE VERAK011497CYMUN-NBR POWDER FREE BLUE NITRILE EXAMINATION GLOVEK002718ULTRA CARE 2 LATEX EXAMINATION GLOVES MADE FROM ALLOTEX (ENZYME TREATED) NATURAL RUBBER LATEX WITH A PROTEIN CONTENT LAB

View all 20 devices →

Related Devices (Code: LZA)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261793Powder-free Nitrile Examination Gloves Tested for Use With Chemotherapy Drugs and Fentanyl Citrate (Blue and Black Color)Maxter Healthcare, Inc.K262542Biodegradable Nitrile Powder Free Examination Glove, Green; Biodegradable Nitrile Powder Free Examination Glove, Violet Blue Tested for Use With 32 Chemotherapy Drugs, Fentanyl & Gastric Acid Permeation Resistance ClaimTop Glove Sdn. Bhd.K260312Nitrile Powder Free Examination Glove, Blue Tested for Use with 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim; Nitrile Powder Free Examination Glove, Violet Blue Tested for Use with 32 Chemotherapy Drugs, Xylazine, Fentanyl & Gastric AcidGmp Medicare Sdn. Bhd.K261749Cardinal Health Nitrile Blue Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl CitrateCardinalhealthK260794NON-STERILE POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, WITH LICORICE ROOT EXTRACT AND UREA, TESTED FOR USE WITH CHEMOTHERAPY DRUGS, FENTANYL CITRATE, XYLAZINE HCl, AND GASTRIC ACID. OCEAN COLORKossan International Sdn BhdK262014PUREZERO* MARIN* Nitrile Powder-Free Exam Gloves; PUREZERO* MARIN-XTRA* Nitrile Powder-Free Exam GlovesO&M Halyard, Inc.

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.

↑