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FDA 510(k)

SEMPERMED SURGEONS' GLOVES - SUPREME

K-Number: K981096 · 1998-10-29

ApplicantSemperit Technische Produkte Gesellshaft
Decision Date1998-10-29
Product CodeKGO
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SEMPERMED SURGEONS' GLOVES - SUPREME is the device name listed in this FDA 510(k) record. The listed applicant is Semperit Technische Produkte Gesellshaft. It received FDA 510(k) clearance on 1998-10-29 under 510(k) number K981096. 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 SEMPERMED SURGEONS' GLOVES - SUPREME?

SEMPERMED SURGEONS' GLOVES - SUPREME is a medical device that received FDA 510(k) clearance on 1998-10-29. The listed applicant is Semperit Technische Produkte Gesellshaft. The 510(k) number is K981096.

When did SEMPERMED SURGEONS' GLOVES - SUPREME receive FDA 510(k) clearance?

SEMPERMED SURGEONS' GLOVES - SUPREME received FDA 510(k) clearance on 1998-10-29, under 510(k) number K981096.

Who is the listed applicant for SEMPERMED SURGEONS' GLOVES - SUPREME?

The FDA 510(k) record lists Semperit Technische Produkte Gesellshaft as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SEMPERMED SURGEONS' GLOVES - SUPREME?

The FDA product code for SEMPERMED SURGEONS' GLOVES - SUPREME is KGO.

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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.

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Other records listing Semperit Technische Produkte Gesellshaft 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.

K013560SEMPERMED SUPREME, SIZES 5.5, 6, 6.5, 7, 7.5, 8, 8.5, AND 9K012819SEMPERMED DERMA PLUS, SIZES 5.5,6,6.5,7,7.5,8,8.5,9

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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