FDA 510(k)

ELASTYREN HYPOALLERGENIC SURGICAL GLOVES

K-Number: K954535 · 1995-12-11

Decision Date1995-12-11

Product CodeKGO

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

ELASTYREN HYPOALLERGENIC SURGICAL GLOVES 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 1995-12-11 under 510(k) number K954535. 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 ELASTYREN HYPOALLERGENIC SURGICAL GLOVES?

ELASTYREN HYPOALLERGENIC SURGICAL GLOVES is a medical device that received FDA 510(k) clearance on 1995-12-11. The listed applicant is Eci Medical Technologies, Inc.. The 510(k) number is K954535.

When did ELASTYREN HYPOALLERGENIC SURGICAL GLOVES receive FDA 510(k) clearance?

ELASTYREN HYPOALLERGENIC SURGICAL GLOVES received FDA 510(k) clearance on 1995-12-11, under 510(k) number K954535.

Who is the listed applicant for ELASTYREN HYPOALLERGENIC SURGICAL GLOVES?

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 ELASTYREN HYPOALLERGENIC SURGICAL GLOVES?

The FDA product code for ELASTYREN HYPOALLERGENIC SURGICAL GLOVES is KGO.

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Other records listing Eci Medical Technologies, Inc. as applicant

K021598ELASTYLITE SYNTHETIC POWDERED SURGICAL GLOVE K020918ELASTYFREE SYNTHETIC POWDER-FREE SURGICAL GLOVE K984337ELASTYLON POWDER-FREE SURGICAL GLOVE K971471ELASTYREN POWDER-FREE SURGICAL GLOVE K970015ELASTYREN POWDER-FREE PATIENT EXAMINATION GLOVES K954533ELASTYREN HYPOALLERGENIC PATIENT EXAMINATION GLOVES

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Related Devices (Code: KGO)

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 Limited K250313Sterile Powder Free Synthetic Rubber Surgeon’s Gloves, Green Color, Tested For Use With Chemotherapy Drugs and Gastric AcidHarps Europe Manufacturing GmbH K240790Polyisoprene 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.