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FDA 510(k)

ANSELL E.P. EXTRA-PROTECTION EXAMINATION GLOVES

K-Number: K895781 · 1990-03-09

ApplicantAnsell Intl.
Decision Date1990-03-09
Product CodeLZC
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ANSELL E.P. EXTRA-PROTECTION EXAMINATION GLOVES is the device name listed in this FDA 510(k) record. The listed applicant is Ansell Intl.. It received FDA 510(k) clearance on 1990-03-09 under 510(k) number K895781. 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 ANSELL E.P. EXTRA-PROTECTION EXAMINATION GLOVES?

ANSELL E.P. EXTRA-PROTECTION EXAMINATION GLOVES is a medical device that received FDA 510(k) clearance on 1990-03-09. The listed applicant is Ansell Intl.. The 510(k) number is K895781.

When did ANSELL E.P. EXTRA-PROTECTION EXAMINATION GLOVES receive FDA 510(k) clearance?

ANSELL E.P. EXTRA-PROTECTION EXAMINATION GLOVES received FDA 510(k) clearance on 1990-03-09, under 510(k) number K895781.

Who is the listed applicant for ANSELL E.P. EXTRA-PROTECTION EXAMINATION GLOVES?

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

What is the FDA product code for ANSELL E.P. EXTRA-PROTECTION EXAMINATION GLOVES?

The FDA product code for ANSELL E.P. EXTRA-PROTECTION EXAMINATION GLOVES is LZC.

Related Clinical Trials

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.

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Other records listing Ansell Intl. 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.

K920745NUTEX GLOVESK904244SENSIDERMK904769SENSITOUCH

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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