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FDA 510(k)

DISPOSABLE POWDER FREE NITRILE EXAM GLOVE, GREEN COLOR

K-Number: K001637 · 2000-06-23

ApplicantSheen More Ent. Co., Ltd.
Decision Date2000-06-23
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

DISPOSABLE POWDER FREE NITRILE EXAM GLOVE, GREEN 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 2000-06-23 under 510(k) number K001637. 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 POWDER FREE NITRILE EXAM GLOVE, GREEN COLOR?

DISPOSABLE POWDER FREE NITRILE EXAM GLOVE, GREEN COLOR is a medical device that received FDA 510(k) clearance on 2000-06-23. The listed applicant is Sheen More Ent. Co., Ltd.. The 510(k) number is K001637.

When did DISPOSABLE POWDER FREE NITRILE EXAM GLOVE, GREEN COLOR receive FDA 510(k) clearance?

DISPOSABLE POWDER FREE NITRILE EXAM GLOVE, GREEN COLOR received FDA 510(k) clearance on 2000-06-23, under 510(k) number K001637.

Who is the listed applicant for DISPOSABLE POWDER FREE NITRILE EXAM GLOVE, GREEN 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 POWDER FREE NITRILE EXAM GLOVE, GREEN COLOR?

The FDA product code for DISPOSABLE POWDER FREE NITRILE EXAM GLOVE, GREEN COLOR is LZA.

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Other records listing Sheen More Ent. Co., 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.

K013998POWDER-FREE LAVENDER/PURPLE NITRILE EXAM GLOVESK001065DISPOSABLE POWDERED NITRILE EXAM GLOVE, BLUE COLORK001155DISPOSABLE POWDERED NITRILE EXAM GLOVE, WHITE COLORK000226DISPOSABLE POWDER FREE NITRILE EXAM GLOVES, WHITE COLORK992686DISPOSABLE POWDER FREE NITRILE EXAM GLOVE, BLUE 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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