FDA 510(k)

DISPOSABLE POWDERED NITRILE EXAM GLOVE, BLUE COLOR

K-Number: K001065 · 2000-05-23

Decision Date2000-05-23

Product CodeLZA

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

DISPOSABLE POWDERED NITRILE EXAM GLOVE, BLUE COLOR is the device name listed in this FDA 510(k) record. The listed applicant is Sheen More Ent. Co., Ltd.. It received FDA 510(k) clearance on 2000-05-23 under 510(k) number K001065. 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 DISPOSABLE POWDERED NITRILE EXAM GLOVE, BLUE COLOR?

DISPOSABLE POWDERED NITRILE EXAM GLOVE, BLUE COLOR is a medical device that received FDA 510(k) clearance on 2000-05-23. The listed applicant is Sheen More Ent. Co., Ltd.. The 510(k) number is K001065.

When did DISPOSABLE POWDERED NITRILE EXAM GLOVE, BLUE COLOR receive FDA 510(k) clearance?

DISPOSABLE POWDERED NITRILE EXAM GLOVE, BLUE COLOR received FDA 510(k) clearance on 2000-05-23, under 510(k) number K001065.

Who is the listed applicant for DISPOSABLE POWDERED NITRILE EXAM GLOVE, BLUE COLOR?

The FDA 510(k) record lists Sheen More Ent. Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DISPOSABLE POWDERED NITRILE EXAM GLOVE, BLUE COLOR?

The FDA product code for DISPOSABLE POWDERED NITRILE EXAM GLOVE, BLUE COLOR is LZA.

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Other records listing Sheen More Ent. Co., Ltd. as applicant

K013998POWDER-FREE LAVENDER/PURPLE NITRILE EXAM GLOVES K001637DISPOSABLE POWDER FREE NITRILE EXAM GLOVE, GREEN COLOR K001155DISPOSABLE POWDERED NITRILE EXAM GLOVE, WHITE COLOR K000226DISPOSABLE POWDER FREE NITRILE EXAM GLOVES, WHITE COLOR K992686DISPOSABLE POWDER FREE NITRILE EXAM GLOVE, BLUE COLOR

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.