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FDA 510(k)

ESP RADIATION REDUCTION EXAMINATION GLOVES

K-Number: K891968 · 1989-05-22

ApplicantBoston Scientific Corp
Decision Date1989-05-22
Product CodeLZC
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ESP RADIATION REDUCTION EXAMINATION GLOVES is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific Corp. It received FDA 510(k) clearance on 1989-05-22 under 510(k) number K891968. 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 ESP RADIATION REDUCTION EXAMINATION GLOVES?

ESP RADIATION REDUCTION EXAMINATION GLOVES is a medical device that received FDA 510(k) clearance on 1989-05-22. The listed applicant is Boston Scientific Corp. The 510(k) number is K891968.

When did ESP RADIATION REDUCTION EXAMINATION GLOVES receive FDA 510(k) clearance?

ESP RADIATION REDUCTION EXAMINATION GLOVES received FDA 510(k) clearance on 1989-05-22, under 510(k) number K891968.

Who is the listed applicant for ESP RADIATION REDUCTION EXAMINATION GLOVES?

The FDA 510(k) record lists Boston Scientific Corp as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ESP RADIATION REDUCTION EXAMINATION GLOVES?

The FDA product code for ESP RADIATION REDUCTION EXAMINATION GLOVES is LZC.

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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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