FDA 510(k)

OMNI PRO LATEX SURGICAL GLOVE, POWDERED

K-Number: K982613 · 1998-09-02

Decision Date1998-09-02

Product CodeKGO

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

OMNI PRO LATEX SURGICAL GLOVE, POWDERED is the device name listed in this FDA 510(k) record. The listed applicant is Omnigrace (Thailand) , Ltd.. It received FDA 510(k) clearance on 1998-09-02 under 510(k) number K982613. 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 OMNI PRO LATEX SURGICAL GLOVE, POWDERED?

OMNI PRO LATEX SURGICAL GLOVE, POWDERED is a medical device that received FDA 510(k) clearance on 1998-09-02. The listed applicant is Omnigrace (Thailand) , Ltd.. The 510(k) number is K982613.

When did OMNI PRO LATEX SURGICAL GLOVE, POWDERED receive FDA 510(k) clearance?

OMNI PRO LATEX SURGICAL GLOVE, POWDERED received FDA 510(k) clearance on 1998-09-02, under 510(k) number K982613.

Who is the listed applicant for OMNI PRO LATEX SURGICAL GLOVE, POWDERED?

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

What is the FDA product code for OMNI PRO LATEX SURGICAL GLOVE, POWDERED?

The FDA product code for OMNI PRO LATEX SURGICAL GLOVE, POWDERED is KGO.

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Other records listing Omnigrace (Thailand) , Ltd. as applicant

K012402OMNI GRACE LATEX EXAMINATION GLOVE, POWDER FREE, POLYMER COATED WITH PROTEIN CLAIM K002922OMNI GRACE LATEX EXAMINATION GLOVE, POWDERED, WITH PROTEIN CLAIM (200 MICROGRAMS OR LESS)K993479OMNI GRACE LATEX EXAMINATION GLOVE, POWDERED, WITH PROTEIN CLAIM (100 MICROGRAMS OR LESS)K990696OMNI FLEX NITRILE EXAMINATION GLOVE, POWDER-FREE,WHITE K990698OMNI TOUCH NITRILE EXAMINATION GLOVE, POWDERED PURPLE K990701OMNI FLEX NITRILE EXAMINATION GLOVE, POWDER-FREE, PURPLE

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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.