FDA 510(k)

MATANG POWDER-FREE POLYCHLOROPRENE PATIENT EXAMINATION GLOVES

K-Number: K032549 · 2003-09-08

Decision Date2003-09-08

Product CodeLZA

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

MATANG POWDER-FREE POLYCHLOROPRENE PATIENT EXAMINATION GLOVES 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 2003-09-08 under 510(k) number K032549. 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 MATANG POWDER-FREE POLYCHLOROPRENE PATIENT EXAMINATION GLOVES?

MATANG POWDER-FREE POLYCHLOROPRENE PATIENT EXAMINATION GLOVES is a medical device that received FDA 510(k) clearance on 2003-09-08. The listed applicant is Matang Mfg. Sdn. Bhd.. The 510(k) number is K032549.

When did MATANG POWDER-FREE POLYCHLOROPRENE PATIENT EXAMINATION GLOVES receive FDA 510(k) clearance?

MATANG POWDER-FREE POLYCHLOROPRENE PATIENT EXAMINATION GLOVES received FDA 510(k) clearance on 2003-09-08, under 510(k) number K032549.

Who is the listed applicant for MATANG POWDER-FREE POLYCHLOROPRENE PATIENT EXAMINATION GLOVES?

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 MATANG POWDER-FREE POLYCHLOROPRENE PATIENT EXAMINATION GLOVES?

The FDA product code for MATANG POWDER-FREE POLYCHLOROPRENE PATIENT EXAMINATION GLOVES is LZA.

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

K122131POWDER FREE NITRILE EXAMINATION GLOVE-BLUE (CHEMOTHERAPY)K121368NITRILE EXAMINATION GLOVE, POWDER FREE (BLUE, BLACK OR WHITE)K072614MATANG BLACK, POWDER FREE AND POLYMER COATED LATEX EXAMINATION GLOVE 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.