Decision Date2011-08-19
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
POWDER FREE NITRILE EXAMINATION GLOVES WHITE COLORED NON-STERILE is the device name listed in this FDA 510(k) record. The listed applicant is Central Medicare Sdn Bhd. It received FDA 510(k) clearance on 2011-08-19 under 510(k) number K103734. 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 POWDER FREE NITRILE EXAMINATION GLOVES WHITE COLORED NON-STERILE?
POWDER FREE NITRILE EXAMINATION GLOVES WHITE COLORED NON-STERILE is a medical device that received FDA 510(k) clearance on 2011-08-19. The listed applicant is Central Medicare Sdn Bhd. The 510(k) number is K103734.
When did POWDER FREE NITRILE EXAMINATION GLOVES WHITE COLORED NON-STERILE receive FDA 510(k) clearance?
POWDER FREE NITRILE EXAMINATION GLOVES WHITE COLORED NON-STERILE received FDA 510(k) clearance on 2011-08-19, under 510(k) number K103734.
Who is the listed applicant for POWDER FREE NITRILE EXAMINATION GLOVES WHITE COLORED NON-STERILE?
The FDA 510(k) record lists Central Medicare Sdn Bhd as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for POWDER FREE NITRILE EXAMINATION GLOVES WHITE COLORED NON-STERILE?
The FDA product code for POWDER FREE NITRILE EXAMINATION GLOVES WHITE COLORED NON-STERILE is LZA.
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Other records listing Central Medicare Sdn Bhd as applicant
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
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Related Devices (Code: LZA)
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
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 CitrateCardinalhealthK260794NON-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 BhdK262014PUREZERO* MARIN* Nitrile Powder-Free Exam Gloves; PUREZERO* MARIN-XTRA* Nitrile Powder-Free Exam GlovesO&M Halyard, Inc.
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.