FDA 510(k)

SMART GLOVE STERILE NITRILE EXAM GLOVE

K-Number: K012853 · 2001-11-16

Decision Date2001-11-16

Product CodeLZA

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

SMART GLOVE STERILE NITRILE EXAM GLOVE 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 2001-11-16 under 510(k) number K012853. 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 SMART GLOVE STERILE NITRILE EXAM GLOVE?

SMART GLOVE STERILE NITRILE EXAM GLOVE is a medical device that received FDA 510(k) clearance on 2001-11-16. The listed applicant is Smart Glove Corp. Sdn Bhd. The 510(k) number is K012853.

When did SMART GLOVE STERILE NITRILE EXAM GLOVE receive FDA 510(k) clearance?

SMART GLOVE STERILE NITRILE EXAM GLOVE received FDA 510(k) clearance on 2001-11-16, under 510(k) number K012853.

Who is the listed applicant for SMART GLOVE STERILE NITRILE EXAM GLOVE?

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 SMART GLOVE STERILE NITRILE EXAM GLOVE?

The FDA product code for SMART GLOVE STERILE NITRILE EXAM GLOVE 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.