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FDA 510(k)

GLOVEL GX

K-Number: K963020 · 1996-11-27

ApplicantKenwell International , Ltd.
Decision Date1996-11-27
Product CodeKGO
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

GLOVEL GX is the device name listed in this FDA 510(k) record. The listed applicant is Kenwell International , Ltd.. It received FDA 510(k) clearance on 1996-11-27 under 510(k) number K963020. 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 GLOVEL GX?

GLOVEL GX is a medical device that received FDA 510(k) clearance on 1996-11-27. The listed applicant is Kenwell International , Ltd.. The 510(k) number is K963020.

When did GLOVEL GX receive FDA 510(k) clearance?

GLOVEL GX received FDA 510(k) clearance on 1996-11-27, under 510(k) number K963020.

Who is the listed applicant for GLOVEL GX?

The FDA 510(k) record lists Kenwell International , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GLOVEL GX?

The FDA product code for GLOVEL GX 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 Kenwell International , Ltd. 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.

K980412COLOURED POWDWR-FREE SURGICAL GLOVESK980803STERILE POWDER-FREE LATEX EXAMINATION GLOVESK911134SURGICAL GLOVESK900811LATEX 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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