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FDA 510(k)

TACTYLON TM SURGICAL GLOVE

K-Number: K902831 · 1990-07-10

ApplicantTactyl Technologies, Inc.
Decision Date1990-07-10
Product CodeKGO
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

TACTYLON TM SURGICAL GLOVE is the device name listed in this FDA 510(k) record. The listed applicant is Tactyl Technologies, Inc.. It received FDA 510(k) clearance on 1990-07-10 under 510(k) number K902831. 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 TACTYLON TM SURGICAL GLOVE?

TACTYLON TM SURGICAL GLOVE is a medical device that received FDA 510(k) clearance on 1990-07-10. The listed applicant is Tactyl Technologies, Inc.. The 510(k) number is K902831.

When did TACTYLON TM SURGICAL GLOVE receive FDA 510(k) clearance?

TACTYLON TM SURGICAL GLOVE received FDA 510(k) clearance on 1990-07-10, under 510(k) number K902831.

Who is the listed applicant for TACTYLON TM SURGICAL GLOVE?

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

What is the FDA product code for TACTYLON TM SURGICAL GLOVE?

The FDA product code for TACTYLON TM SURGICAL GLOVE is KGO.

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Other records listing Tactyl 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.

K955464TACTYLON POWDER FREE EXAMINATION GLOVEK955419POWDER FREE TACTYLON SURGEONS GLOVEK953583LUBRICATED CONDOMK950185TACTYLON(TM) POWDER FREE SURGEONS GLOVEK911431TACTYLON(TM) CONDOMK905109PATIENT EXAMINATION GLOVE/HYPOALLERGENIC

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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.

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