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FDA 510(k)

FLUORO-SHIELD RADIATION REDUCTION GLOVES

K-Number: K920620 · 1993-06-22

ApplicantAcufex Microsurgical, Inc.
Decision Date1993-06-22
Product CodeLZC
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

FLUORO-SHIELD RADIATION REDUCTION GLOVES is the device name listed in this FDA 510(k) record. The listed applicant is Acufex Microsurgical, Inc.. It received FDA 510(k) clearance on 1993-06-22 under 510(k) number K920620. The device is classified under product code LZC. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FLUORO-SHIELD RADIATION REDUCTION GLOVES?

FLUORO-SHIELD RADIATION REDUCTION GLOVES is a medical device that received FDA 510(k) clearance on 1993-06-22. The listed applicant is Acufex Microsurgical, Inc.. The 510(k) number is K920620.

When did FLUORO-SHIELD RADIATION REDUCTION GLOVES receive FDA 510(k) clearance?

FLUORO-SHIELD RADIATION REDUCTION GLOVES received FDA 510(k) clearance on 1993-06-22, under 510(k) number K920620.

Who is the listed applicant for FLUORO-SHIELD RADIATION REDUCTION GLOVES?

The FDA 510(k) record lists Acufex Microsurgical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FLUORO-SHIELD RADIATION REDUCTION GLOVES?

The FDA product code for FLUORO-SHIELD RADIATION REDUCTION GLOVES is LZC.

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Other records listing Acufex Microsurgical, Inc. 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.

K961555ACUFEX TAG BIOABSORBABLE ANCHORSK961853PROLINE FAST PASS ARTHOSCOPIC NEEDLE PASSERK954246ACUFEX ENDOFIX ABSORBABLE INTERFERENCE SCREWK952535ACUFEX ENDOBUTTON TAPEK953276ACUFEX TAG DELIVERY SYSTEMK953459ACUFEX TAG ANCHOR

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Related Devices (Code: LZC)

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K252313Cardinal Health Nitrile Examination Gloves Extended CuffCardinalhealthK243959Powder Free Nitrile Examination Gloves (Violet, Black, Green), Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Select Other DrugsLingshi Hongruida Health Protection Technology Co., Ltd.K221157JR MedicJr Engineering & Medical Technologies (M) Sdn. Bhd.K222449Nitrile Powder Free Examination Gloves, Tested For Use With Chemotherapy Drugs And Fentanyl Citrate (Dark Blue)Better Care Plastic Technology Co., Ltd.K220545Powder Free Nitrile Examination Gloves, Blue, Tested for use with Chemotherapy DrugsHl Rubber Industries Sdn BhdK220491Disposable Medical Nitrile Examination Gloves -Tested for Use with Chemotherapy DrugsHainan Asther Medical Equipment Co., Ltd.

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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