FDA 510(k)

MASTER GUARD NITRILE BLUE POWDER FREE EXAMINATION GLOVES

K-Number: K071208 · 2007-07-30

Decision Date2007-07-30

Product CodeLZA

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

MASTER GUARD NITRILE BLUE POWDER FREE EXAMINATION GLOVES is the device name listed in this FDA 510(k) record. The listed applicant is High Momentum Sdn Bhd. It received FDA 510(k) clearance on 2007-07-30 under 510(k) number K071208. 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 MASTER GUARD NITRILE BLUE POWDER FREE EXAMINATION GLOVES?

MASTER GUARD NITRILE BLUE POWDER FREE EXAMINATION GLOVES is a medical device that received FDA 510(k) clearance on 2007-07-30. The listed applicant is High Momentum Sdn Bhd. The 510(k) number is K071208.

When did MASTER GUARD NITRILE BLUE POWDER FREE EXAMINATION GLOVES receive FDA 510(k) clearance?

MASTER GUARD NITRILE BLUE POWDER FREE EXAMINATION GLOVES received FDA 510(k) clearance on 2007-07-30, under 510(k) number K071208.

Who is the listed applicant for MASTER GUARD NITRILE BLUE POWDER FREE EXAMINATION GLOVES?

The FDA 510(k) record lists High Momentum Sdn Bhd as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MASTER GUARD NITRILE BLUE POWDER FREE EXAMINATION GLOVES?

The FDA product code for MASTER GUARD NITRILE BLUE POWDER FREE EXAMINATION GLOVES is LZA.

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Other records listing High Momentum Sdn Bhd as applicant

K071207MASTER GUARD NITRILE BLUE POWDERED EXAMINATION GLOVES K071209MASTER GUARD LATEX POWDER FREE EXAMINATION GLOVES K060858LATEX POWDERED EXAMINATION GLOVE

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.