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FDA 510(k)

POWDER FREE NITRILE EXAMINATION GLOVE WITH TESTED FOR USE WITH CHEMOTHERAPY DRUGS LABELING CLAIM (BLUE)

K-Number: K050598 · 2005-04-07

ApplicantSmart Glove Corp. Sdn Bhd
Decision Date2005-04-07
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

POWDER FREE NITRILE EXAMINATION GLOVE WITH TESTED FOR USE WITH CHEMOTHERAPY DRUGS LABELING CLAIM (BLUE) is the device name listed in this FDA 510(k) record. The listed applicant is Smart Glove Corp. Sdn Bhd. It received FDA 510(k) clearance on 2005-04-07 under 510(k) number K050598. 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 GLOVE WITH TESTED FOR USE WITH CHEMOTHERAPY DRUGS LABELING CLAIM (BLUE)?

POWDER FREE NITRILE EXAMINATION GLOVE WITH TESTED FOR USE WITH CHEMOTHERAPY DRUGS LABELING CLAIM (BLUE) is a medical device that received FDA 510(k) clearance on 2005-04-07. The listed applicant is Smart Glove Corp. Sdn Bhd. The 510(k) number is K050598.

When did POWDER FREE NITRILE EXAMINATION GLOVE WITH TESTED FOR USE WITH CHEMOTHERAPY DRUGS LABELING CLAIM (BLUE) receive FDA 510(k) clearance?

POWDER FREE NITRILE EXAMINATION GLOVE WITH TESTED FOR USE WITH CHEMOTHERAPY DRUGS LABELING CLAIM (BLUE) received FDA 510(k) clearance on 2005-04-07, under 510(k) number K050598.

Who is the listed applicant for POWDER FREE NITRILE EXAMINATION GLOVE WITH TESTED FOR USE WITH CHEMOTHERAPY DRUGS LABELING CLAIM (BLUE)?

The FDA 510(k) record lists Smart Glove Corp. 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 GLOVE WITH TESTED FOR USE WITH CHEMOTHERAPY DRUGS LABELING CLAIM (BLUE)?

The FDA product code for POWDER FREE NITRILE EXAMINATION GLOVE WITH TESTED FOR USE WITH CHEMOTHERAPY DRUGS LABELING CLAIM (BLUE) is LZA.

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Other records listing Smart Glove Corp. 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.

K091147POWDER FREE NITRILE EXAMINATION GLOVE (BLUE)K082370POWDER FREE NITRILE EXAMINATION GLOVE (BLUE)K081466STERILE, POWDER FREE NITRILE EXAMINATION GLOVES, BLUEK071170POWDER FREE NITRILE EXAMINATION GLOVES, MAGENTA AND WHITE COLOR COATED WITH ALLOGELK063627POWDER FREE NITRILE EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGS (BLUE)K061724POWDER FREE NITRILE EXAMINATION GLOVE, GRAPE SCENTED (BLUE AND WHITE)

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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.

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