FDA 510(k)

NITRILE PRE-POWDERED EXAMINATION GLOVES

K-Number: K974907 · 1998-03-13

Decision Date1998-03-13

Product CodeLZA

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

NITRILE PRE-POWDERED EXAMINATION GLOVES is the device name listed in this FDA 510(k) record. The listed applicant is Smart Glove Corp. Sdn Bhd. It received FDA 510(k) clearance on 1998-03-13 under 510(k) number K974907. 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 PRE-POWDERED EXAMINATION GLOVES?

NITRILE PRE-POWDERED EXAMINATION GLOVES is a medical device that received FDA 510(k) clearance on 1998-03-13. The listed applicant is Smart Glove Corp. Sdn Bhd. The 510(k) number is K974907.

When did NITRILE PRE-POWDERED EXAMINATION GLOVES receive FDA 510(k) clearance?

NITRILE PRE-POWDERED EXAMINATION GLOVES received FDA 510(k) clearance on 1998-03-13, under 510(k) number K974907.

Who is the listed applicant for NITRILE PRE-POWDERED EXAMINATION GLOVES?

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

What is the FDA product code for NITRILE PRE-POWDERED EXAMINATION GLOVES?

The FDA product code for NITRILE PRE-POWDERED EXAMINATION GLOVES is LZA.

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Other records listing Smart Glove Corp. Sdn Bhd as applicant

K091147POWDER FREE NITRILE EXAMINATION GLOVE (BLUE)K082370POWDER FREE NITRILE EXAMINATION GLOVE (BLUE)K081466STERILE, POWDER FREE NITRILE EXAMINATION GLOVES, BLUE K071170POWDER FREE NITRILE EXAMINATION GLOVES, MAGENTA AND WHITE COLOR COATED WITH ALLOGEL K063627POWDER FREE NITRILE EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGS (BLUE)K061724POWDER FREE NITRILE EXAMINATION GLOVE, GRAPE SCENTED (BLUE AND WHITE)

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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.