FDA 510(k)

NITRILE COPOLYMER PATIENT EXAMINATION GLOVES

K-Number: K962518 · 1996-12-19

Decision Date1996-12-19

Product CodeLZA

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

NITRILE COPOLYMER PATIENT EXAMINATION GLOVES is the device name listed in this FDA 510(k) record. The listed applicant is P.T. Irama Dinamika Latex. It received FDA 510(k) clearance on 1996-12-19 under 510(k) number K962518. 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 NITRILE COPOLYMER PATIENT EXAMINATION GLOVES?

NITRILE COPOLYMER PATIENT EXAMINATION GLOVES is a medical device that received FDA 510(k) clearance on 1996-12-19. The listed applicant is P.T. Irama Dinamika Latex. The 510(k) number is K962518.

When did NITRILE COPOLYMER PATIENT EXAMINATION GLOVES receive FDA 510(k) clearance?

NITRILE COPOLYMER PATIENT EXAMINATION GLOVES received FDA 510(k) clearance on 1996-12-19, under 510(k) number K962518.

Who is the listed applicant for NITRILE COPOLYMER PATIENT EXAMINATION GLOVES?

The FDA 510(k) record lists P.T. Irama Dinamika Latex as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NITRILE COPOLYMER PATIENT EXAMINATION GLOVES?

The FDA product code for NITRILE COPOLYMER PATIENT EXAMINATION GLOVES is LZA.

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Other records listing P.T. Irama Dinamika Latex as applicant

K984449NATURAL RUBBER PRE-POWDERED COLORED & FLAVORED PATIENT EXAMINATION GLOVES WITH PROTEIN LABELLING CLAIM K981064POWDERFREE COLORED AND FLAVORED CHLOROPRENE PATIENT EXAMINATION GLOVES K980848HYPOALLERGENIC LATEX PATIENT EXAM GLOVES-PREPOWDERED K972306POWDERFREE COLORED AND FLAVORED NITRILE COPOLYMER PATIENT EXAMINATION GLOVES-MEDICAL DEVICE K965155LATEX EXAM GLOVES K963771CHLOROPRENE EXAM GLOVES

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Related Devices (Code: LZA)

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 CitrateCardinalhealth K260794NON-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 Bhd K262014PUREZERO* MARIN* Nitrile Powder-Free Exam Gloves; PUREZERO* MARIN-XTRA* Nitrile Powder-Free Exam GlovesO&M Halyard, Inc.

Official Source

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