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FDA 510(k)

POWDER FREE NITRILE EXAMINATION GLOVES BLACK; BLUE, GRAPE SCENTED

K-Number: K091965 · 2009-11-24

ApplicantPlatinum Glove Industries Sdn. Bhd.
Decision Date2009-11-24
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

POWDER FREE NITRILE EXAMINATION GLOVES BLACK; BLUE, GRAPE SCENTED is the device name listed in this FDA 510(k) record. The listed applicant is Platinum Glove Industries Sdn. Bhd.. It received FDA 510(k) clearance on 2009-11-24 under 510(k) number K091965. 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 BLACK; BLUE, GRAPE SCENTED?

POWDER FREE NITRILE EXAMINATION GLOVES BLACK; BLUE, GRAPE SCENTED is a medical device that received FDA 510(k) clearance on 2009-11-24. The listed applicant is Platinum Glove Industries Sdn. Bhd.. The 510(k) number is K091965.

When did POWDER FREE NITRILE EXAMINATION GLOVES BLACK; BLUE, GRAPE SCENTED receive FDA 510(k) clearance?

POWDER FREE NITRILE EXAMINATION GLOVES BLACK; BLUE, GRAPE SCENTED received FDA 510(k) clearance on 2009-11-24, under 510(k) number K091965.

Who is the listed applicant for POWDER FREE NITRILE EXAMINATION GLOVES BLACK; BLUE, GRAPE SCENTED?

The FDA 510(k) record lists Platinum Glove Industries 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 BLACK; BLUE, GRAPE SCENTED?

The FDA product code for POWDER FREE NITRILE EXAMINATION GLOVES BLACK; BLUE, GRAPE SCENTED is LZA.

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Other records listing Platinum Glove Industries 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.

K182089Powder Free Blue Nitrile Examination Gloves - Tested for Use with Chemotherapy DrugsK080165SMART SAVERS POWDER FREE NITRILE EXAMINATION GLOVE (BLUE, WHITE, PINK AND GRAY)K051372POWDER FREE NITRILE EXAMINATION GLOVES WITH PEPPERMINT SCENTED (BLUE COLOR)K051317POLYMER COATED POWDER FREE NITRILE EXAMINATION GLOVES, BLUE, GREEN AND WHITE COLORK051318POWDER FREE NITRILE EXAMINATION GLOVES (WHITE, BLUE, AND PURPLE COLOR)

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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