Decision Date2011-12-01
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
NON-STERILE, POWDER-FREE NITRILE EXAMINATION GLOVES (ORIGINAL BLUE, COBALT BLUE) is the device name listed in this FDA 510(k) record. The listed applicant is Yty Industry (Manjung) Sdn Bhd. It received FDA 510(k) clearance on 2011-12-01 under 510(k) number K111248. 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 NON-STERILE, POWDER-FREE NITRILE EXAMINATION GLOVES (ORIGINAL BLUE, COBALT BLUE)?
NON-STERILE, POWDER-FREE NITRILE EXAMINATION GLOVES (ORIGINAL BLUE, COBALT BLUE) is a medical device that received FDA 510(k) clearance on 2011-12-01. The listed applicant is Yty Industry (Manjung) Sdn Bhd. The 510(k) number is K111248.
When did NON-STERILE, POWDER-FREE NITRILE EXAMINATION GLOVES (ORIGINAL BLUE, COBALT BLUE) receive FDA 510(k) clearance?
NON-STERILE, POWDER-FREE NITRILE EXAMINATION GLOVES (ORIGINAL BLUE, COBALT BLUE) received FDA 510(k) clearance on 2011-12-01, under 510(k) number K111248.
Who is the listed applicant for NON-STERILE, POWDER-FREE NITRILE EXAMINATION GLOVES (ORIGINAL BLUE, COBALT BLUE)?
The FDA 510(k) record lists Yty Industry (Manjung) Sdn Bhd as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for NON-STERILE, POWDER-FREE NITRILE EXAMINATION GLOVES (ORIGINAL BLUE, COBALT BLUE)?
The FDA product code for NON-STERILE, POWDER-FREE NITRILE EXAMINATION GLOVES (ORIGINAL BLUE, COBALT BLUE) is LZA.
Related Clinical Trials
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.
Other records listing Yty Industry (Manjung) 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.
K220644Non-sterile, Powder Free, ambidextrous, textured, beaded cuff, single use, Doffy® Nitrile Examination Glove, Tested for use with Chemotherapy DrugsK202536Non-sterile, Powder Free Nitrile Examination Aloe Vera Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs, And Non-Sterile, Powder Free Nitrile Examination Gloves, Tested for use with Chemotherapy Drugs and Fentanyl CitrateK200453NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVES, LOW DERMATITIS POTENTIAL, AND TESTED FOR USE WITH CHEMOTHERAPY DRUGS BLUE-ACK182383Non-Sterile, PF Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs-BlueK171104Non-Sterile, Powder Free Nitrile Examination Gloves, Tested for use with Chemotherapy Drugs (Blue, Cobalt Blue)K162095Non-Sterile, Powder Free Nitrile Examination Gloves, Tested for use with Chemotherapy Drugs (Original Blue, Cobalt Blue) View all 23 devices →
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.