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FDA 510(k)

POLYMER COATED POWDER FREE NITRILE EXAMINATION GLOVES (BLUE,WHITE,VIOLET, PINK,GREEN)

K-Number: K050530 · 2005-03-16

ApplicantSpi Gloves Sdn. Bhd.
Decision Date2005-03-16
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

POLYMER COATED POWDER FREE NITRILE EXAMINATION GLOVES (BLUE,WHITE,VIOLET, PINK,GREEN) is the device name listed in this FDA 510(k) record. The listed applicant is Spi Gloves Sdn. Bhd.. It received FDA 510(k) clearance on 2005-03-16 under 510(k) number K050530. 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 POLYMER COATED POWDER FREE NITRILE EXAMINATION GLOVES (BLUE,WHITE,VIOLET, PINK,GREEN)?

POLYMER COATED POWDER FREE NITRILE EXAMINATION GLOVES (BLUE,WHITE,VIOLET, PINK,GREEN) is a medical device that received FDA 510(k) clearance on 2005-03-16. The listed applicant is Spi Gloves Sdn. Bhd.. The 510(k) number is K050530.

When did POLYMER COATED POWDER FREE NITRILE EXAMINATION GLOVES (BLUE,WHITE,VIOLET, PINK,GREEN) receive FDA 510(k) clearance?

POLYMER COATED POWDER FREE NITRILE EXAMINATION GLOVES (BLUE,WHITE,VIOLET, PINK,GREEN) received FDA 510(k) clearance on 2005-03-16, under 510(k) number K050530.

Who is the listed applicant for POLYMER COATED POWDER FREE NITRILE EXAMINATION GLOVES (BLUE,WHITE,VIOLET, PINK,GREEN)?

The FDA 510(k) record lists Spi Gloves Sdn. Bhd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for POLYMER COATED POWDER FREE NITRILE EXAMINATION GLOVES (BLUE,WHITE,VIOLET, PINK,GREEN)?

The FDA product code for POLYMER COATED POWDER FREE NITRILE EXAMINATION GLOVES (BLUE,WHITE,VIOLET, PINK,GREEN) is LZA.

Related Clinical Trials

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Other records listing Spi Gloves 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.

K050526POLYMER COATED ONLINE CHLORINATED POWDER FREE EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (CONTAINS 50 MICROGRAMS ORK050528POWDER FREE NITRILE EXAMINATION GLOVES (BLUE,WHITE,VIOLET,PINK,GREEN,BLACK)K050532CHLORINATED POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (CONTAINS 50 MICROGRAMS OR LESS OF TOTAL WAK050527POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (CONTAINS 200 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLK050531POWDERED NITRILE EXAMINATION GLOVES (BLUE,WHITE)K050529POLYMER COATED POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (CONTAINS 50 MICROGRAMS OR LESS OF TOTER

View all 7 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.

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