Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

ELASTYLON POWDER-FREE SURGICAL GLOVE

K-Number: K984337 · 1999-04-09

ApplicantEci Medical Technologies, Inc.
Decision Date1999-04-09
Product CodeKGO
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ELASTYLON POWDER-FREE SURGICAL GLOVE is the device name listed in this FDA 510(k) record. The listed applicant is Eci Medical Technologies, Inc.. It received FDA 510(k) clearance on 1999-04-09 under 510(k) number K984337. 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 ELASTYLON POWDER-FREE SURGICAL GLOVE?

ELASTYLON POWDER-FREE SURGICAL GLOVE is a medical device that received FDA 510(k) clearance on 1999-04-09. The listed applicant is Eci Medical Technologies, Inc.. The 510(k) number is K984337.

When did ELASTYLON POWDER-FREE SURGICAL GLOVE receive FDA 510(k) clearance?

ELASTYLON POWDER-FREE SURGICAL GLOVE received FDA 510(k) clearance on 1999-04-09, under 510(k) number K984337.

Who is the listed applicant for ELASTYLON POWDER-FREE SURGICAL GLOVE?

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

What is the FDA product code for ELASTYLON POWDER-FREE SURGICAL GLOVE?

The FDA product code for ELASTYLON POWDER-FREE SURGICAL GLOVE 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 Eci Medical Technologies, 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.

K021598ELASTYLITE SYNTHETIC POWDERED SURGICAL GLOVEK020918ELASTYFREE SYNTHETIC POWDER-FREE SURGICAL GLOVEK971471ELASTYREN POWDER-FREE SURGICAL GLOVEK970015ELASTYREN POWDER-FREE PATIENT EXAMINATION GLOVESK954533ELASTYREN HYPOALLERGENIC PATIENT EXAMINATION GLOVESK954535ELASTYREN HYPOALLERGENIC SURGICAL GLOVES

View all 9 devices →

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

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑