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FDA 510(k)

OMNI FLEX NITRILE EXAMINATION GLOVE, POWDER-FREE, PURPLE

K-Number: K990701 · 1999-05-05

ApplicantOmnigrace (Thailand) , Ltd.
Decision Date1999-05-05
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

OMNI FLEX NITRILE EXAMINATION GLOVE, POWDER-FREE, PURPLE is the device name listed in this FDA 510(k) record. The listed applicant is Omnigrace (Thailand) , Ltd.. It received FDA 510(k) clearance on 1999-05-05 under 510(k) number K990701. 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 OMNI FLEX NITRILE EXAMINATION GLOVE, POWDER-FREE, PURPLE?

OMNI FLEX NITRILE EXAMINATION GLOVE, POWDER-FREE, PURPLE is a medical device that received FDA 510(k) clearance on 1999-05-05. The listed applicant is Omnigrace (Thailand) , Ltd.. The 510(k) number is K990701.

When did OMNI FLEX NITRILE EXAMINATION GLOVE, POWDER-FREE, PURPLE receive FDA 510(k) clearance?

OMNI FLEX NITRILE EXAMINATION GLOVE, POWDER-FREE, PURPLE received FDA 510(k) clearance on 1999-05-05, under 510(k) number K990701.

Who is the listed applicant for OMNI FLEX NITRILE EXAMINATION GLOVE, POWDER-FREE, PURPLE?

The FDA 510(k) record lists Omnigrace (Thailand) , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OMNI FLEX NITRILE EXAMINATION GLOVE, POWDER-FREE, PURPLE?

The FDA product code for OMNI FLEX NITRILE EXAMINATION GLOVE, POWDER-FREE, PURPLE is LZA.

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Other records listing Omnigrace (Thailand) , Ltd. 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.

K012402OMNI GRACE LATEX EXAMINATION GLOVE, POWDER FREE, POLYMER COATED WITH PROTEIN CLAIMK002922OMNI GRACE LATEX EXAMINATION GLOVE, POWDERED, WITH PROTEIN CLAIM (200 MICROGRAMS OR LESS)K993479OMNI GRACE LATEX EXAMINATION GLOVE, POWDERED, WITH PROTEIN CLAIM (100 MICROGRAMS OR LESS)K990698OMNI TOUCH NITRILE EXAMINATION GLOVE, POWDERED PURPLEK990696OMNI FLEX NITRILE EXAMINATION GLOVE, POWDER-FREE,WHITEK990702OMNI GRACE LATEX EXAMINATION GLOVE, POWDER-FREE, POLYMER COATED WITH PROTEIN CLAIM

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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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