FDA 510(k)

NITRILE PATIENT EXAMINATION GLOVES, POWDER-FREE, PURPLE

K-Number: K014285 · 2002-02-14

ApplicantFormosa Glove Industrial Co., Ltd.

Decision Date2002-02-14

Product CodeLZA

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

NITRILE PATIENT EXAMINATION GLOVES, POWDER-FREE, PURPLE is the device name listed in this FDA 510(k) record. The listed applicant is Formosa Glove Industrial Co., Ltd.. It received FDA 510(k) clearance on 2002-02-14 under 510(k) number K014285. 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 NITRILE PATIENT EXAMINATION GLOVES, POWDER-FREE, PURPLE?

NITRILE PATIENT EXAMINATION GLOVES, POWDER-FREE, PURPLE is a medical device that received FDA 510(k) clearance on 2002-02-14. The listed applicant is Formosa Glove Industrial Co., Ltd.. The 510(k) number is K014285.

When did NITRILE PATIENT EXAMINATION GLOVES, POWDER-FREE, PURPLE receive FDA 510(k) clearance?

NITRILE PATIENT EXAMINATION GLOVES, POWDER-FREE, PURPLE received FDA 510(k) clearance on 2002-02-14, under 510(k) number K014285.

Who is the listed applicant for NITRILE PATIENT EXAMINATION GLOVES, POWDER-FREE, PURPLE?

The FDA 510(k) record lists Formosa Glove Industrial Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NITRILE PATIENT EXAMINATION GLOVES, POWDER-FREE, PURPLE?

The FDA product code for NITRILE PATIENT EXAMINATION GLOVES, POWDER-FREE, PURPLE is LZA.

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Other records listing Formosa Glove Industrial Co., Ltd. as applicant

K014284NITRILE PATIENT EXAMINATION GLOVES, POWDER-FREE AND YELLOWISH WHITE K992588BLUE NITRILE PATIENT EXAMINATION GLOVES, POWDER-FREE

Related Devices (Code: LZA)

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 CitrateCardinalhealth K260794NON-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 Bhd K262014PUREZERO* 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.