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FDA 510(k)

Polyisoprene Powder Free, Black Colour Surgical Gloves

K-Number: K192933 · 2021-01-13

ApplicantEmerson & Co. Srl
Decision Date2021-01-13
Product CodeKGO
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Polyisoprene Powder Free, Black Colour Surgical Gloves is the device name listed in this FDA 510(k) record. The listed applicant is Emerson & Co. Srl. It received FDA 510(k) clearance on 2021-01-13 under 510(k) number K192933. 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 Polyisoprene Powder Free, Black Colour Surgical Gloves?

Polyisoprene Powder Free, Black Colour Surgical Gloves is a medical device that received FDA 510(k) clearance on 2021-01-13. The listed applicant is Emerson & Co. Srl. The 510(k) number is K192933.

When did Polyisoprene Powder Free, Black Colour Surgical Gloves receive FDA 510(k) clearance?

Polyisoprene Powder Free, Black Colour Surgical Gloves received FDA 510(k) clearance on 2021-01-13, under 510(k) number K192933.

Who is the listed applicant for Polyisoprene Powder Free, Black Colour Surgical Gloves?

The FDA 510(k) record lists Emerson & Co. Srl as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Polyisoprene Powder Free, Black Colour Surgical Gloves?

The FDA product code for Polyisoprene Powder Free, Black Colour Surgical Gloves is KGO.

Other records listing Emerson & Co. Srl 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.

K151228PROGUARD Polyisoprene Powder Free, Black Colour Surgical Gloves, Model 1: .22mm Model 2: .30mm

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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