FDA 510(k)

NITRILE EXAMINATION GLOVE, POWDER FREE (BLUE, BLACK OR WHITE)

K-Number: K121368 · 2012-08-10

Decision Date2012-08-10

Product CodeLZA

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

NITRILE EXAMINATION GLOVE, POWDER FREE (BLUE, BLACK OR WHITE) is the device name listed in this FDA 510(k) record. The listed applicant is Matang Mfg. Sdn. Bhd.. It received FDA 510(k) clearance on 2012-08-10 under 510(k) number K121368. 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 EXAMINATION GLOVE, POWDER FREE (BLUE, BLACK OR WHITE)?

NITRILE EXAMINATION GLOVE, POWDER FREE (BLUE, BLACK OR WHITE) is a medical device that received FDA 510(k) clearance on 2012-08-10. The listed applicant is Matang Mfg. Sdn. Bhd.. The 510(k) number is K121368.

When did NITRILE EXAMINATION GLOVE, POWDER FREE (BLUE, BLACK OR WHITE) receive FDA 510(k) clearance?

NITRILE EXAMINATION GLOVE, POWDER FREE (BLUE, BLACK OR WHITE) received FDA 510(k) clearance on 2012-08-10, under 510(k) number K121368.

Who is the listed applicant for NITRILE EXAMINATION GLOVE, POWDER FREE (BLUE, BLACK OR WHITE)?

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

What is the FDA product code for NITRILE EXAMINATION GLOVE, POWDER FREE (BLUE, BLACK OR WHITE)?

The FDA product code for NITRILE EXAMINATION GLOVE, POWDER FREE (BLUE, BLACK OR WHITE) is LZA.

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Other records listing Matang Mfg. Sdn. Bhd. as applicant

K122131POWDER FREE NITRILE EXAMINATION GLOVE-BLUE (CHEMOTHERAPY)K072614MATANG BLACK, POWDER FREE AND POLYMER COATED LATEX EXAMINATION GLOVE K032549MATANG POWDER-FREE POLYCHLOROPRENE PATIENT EXAMINATION GLOVES K012558POWDER FREE LATEX PATIENT EXAMINATION GLOVES WITH ALOE VERA AND PROTEIN CONTENT LABELING CLAIM OF 50 MICROGRAMS OR LESS K000985MATANG POWDERED LATEX PATIENT EXAMINATION GLOVE WITH PROTEIN LABELING CLAIM (50 MICROGRAM OR LESS K982877MATANG POWDER-FREE LOW PROTEIN LATEX PATIENT EXAMINATION GLOVE

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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.