Decision Date2006-10-27
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
STERILE POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE COLORED is the device name listed in this FDA 510(k) record. The listed applicant is Wear Safe Malaysia Sdn. Bhd.. It received FDA 510(k) clearance on 2006-10-27 under 510(k) number K062778. 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 STERILE POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE COLORED?
STERILE POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE COLORED is a medical device that received FDA 510(k) clearance on 2006-10-27. The listed applicant is Wear Safe Malaysia Sdn. Bhd.. The 510(k) number is K062778.
When did STERILE POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE COLORED receive FDA 510(k) clearance?
STERILE POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE COLORED received FDA 510(k) clearance on 2006-10-27, under 510(k) number K062778.
Who is the listed applicant for STERILE POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE COLORED?
The FDA 510(k) record lists Wear Safe Malaysia Sdn. Bhd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for STERILE POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE COLORED?
The FDA product code for STERILE POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE COLORED 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 Wear Safe Malaysia 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.
K172420Sterile Powder Free Nitrile Surgical Glove, White Colored. Tested for Use with Chemotherapy Drugs, with Non-Pyrogenic Labeling ClaimK101799POWDER FREE LATEX EXAMINATION GLOVES BLUE (COLORED), NON-STERILE, WITH PROTEIN LABELING CLAIM OF 50UG PER DM2 OF GLOVEK093500POWDER FREE NITRILE EXAMINATION GLOVES, WHITE (NON-COLORED) OR BLUE (COLORED), NON-STERILEK092492POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVES, NON-STERILE, WITH PROTEIN LABELING CLAIM OF 50 MICROGRAMS PER DM2 OK090066POWDER FREE POLYMER COATED LATEX SURGICAL GLOVES, STERILE, WITH PROTEIN LABELING CLAIM OF 50 MICROGRAMS PER DM2 OF GLOVEK090327POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVES, STERILE, WITH PROTEIN LABELING CLAIM OF 50 UG PER DM2 OF GLOVE View all 14 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.