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FDA 510(k)

AUKUFLEX(TM) RADIATION RESISTANT GLOVES

K-Number: K903142 · 1990-10-26

ApplicantAukland Mfg., Inc.
Decision Date1990-10-26
Product CodeLZC
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

AUKUFLEX(TM) RADIATION RESISTANT GLOVES is the device name listed in this FDA 510(k) record. The listed applicant is Aukland Mfg., Inc.. It received FDA 510(k) clearance on 1990-10-26 under 510(k) number K903142. 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 AUKUFLEX(TM) RADIATION RESISTANT GLOVES?

AUKUFLEX(TM) RADIATION RESISTANT GLOVES is a medical device that received FDA 510(k) clearance on 1990-10-26. The listed applicant is Aukland Mfg., Inc.. The 510(k) number is K903142.

When did AUKUFLEX(TM) RADIATION RESISTANT GLOVES receive FDA 510(k) clearance?

AUKUFLEX(TM) RADIATION RESISTANT GLOVES received FDA 510(k) clearance on 1990-10-26, under 510(k) number K903142.

Who is the listed applicant for AUKUFLEX(TM) RADIATION RESISTANT GLOVES?

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

What is the FDA product code for AUKUFLEX(TM) RADIATION RESISTANT GLOVES?

The FDA product code for AUKUFLEX(TM) RADIATION RESISTANT GLOVES is LZC.

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Other records listing Aukland Mfg., 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.

K893606PATIENT EXAMINATION GLOVES

Related Devices (Code: LZC)

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.

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

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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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