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FDA 510(k)

AMMEL STERILE SURGEON'S GLOVES

K-Number: K894501 · 1989-08-10

ApplicantMauricio Menconi
Decision Date1989-08-10
Product CodeKGO
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

AMMEL STERILE SURGEON'S GLOVES is the device name listed in this FDA 510(k) record. The listed applicant is Mauricio Menconi. It received FDA 510(k) clearance on 1989-08-10 under 510(k) number K894501. The device is classified under product code KGO. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMMEL STERILE SURGEON'S GLOVES?

AMMEL STERILE SURGEON'S GLOVES is a medical device that received FDA 510(k) clearance on 1989-08-10. The listed applicant is Mauricio Menconi. The 510(k) number is K894501.

When did AMMEL STERILE SURGEON'S GLOVES receive FDA 510(k) clearance?

AMMEL STERILE SURGEON'S GLOVES received FDA 510(k) clearance on 1989-08-10, under 510(k) number K894501.

Who is the listed applicant for AMMEL STERILE SURGEON'S GLOVES?

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

What is the FDA product code for AMMEL STERILE SURGEON'S GLOVES?

The FDA product code for AMMEL STERILE SURGEON'S GLOVES is KGO.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Mauricio Menconi 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.

K894502AMMEL PATIENT EXAMINATION GLOVES

Related Devices (Code: KGO)

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.

K260558Latex Powder Free Surgical Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Latex Powder Free Surgical Gloves with Colloidal Oatmeal Tested for Use with Chemotherapy Drugs and Fentanyl CitrateHartalega NGC Sdn. Bhd.K253060Sterile Latex Powder Free Surgical GlovesProtect Gloves Company LimitedK250313Sterile Powder Free Synthetic Rubber Surgeon’s Gloves, Green Color, Tested For Use With Chemotherapy Drugs and Gastric AcidHarps Europe Manufacturing GmbHK240790Polyisoprene Surgical glovesSuzhou Colour-Way New Material Co., Ltd.K232079Natural Rubber Latex Surgical Glove, Powder Free, Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl (Green); Natural Rubber Latex (Strip&Coat)/(Strip&Pack) Surgical Glove, Powder Free, Sterile, Tested for Use with Chemotherapy Drugs and FentanylWrp Asia Pacific Sdn. Bhd.K232444Sterile Powder Free Latex Surgical Gloves, Tested for Use with Chemotherapy DrugsGrand Work Plastic Products 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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