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FDA 510(k)

TRIFLEX(R) POWDER FREE STERILE SURGEON'S GLOVE

K-Number: K913207 · 1991-09-11

ApplicantBaxter Healthcare Corp
Decision Date1991-09-11
Product CodeKGO
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

TRIFLEX(R) POWDER FREE STERILE SURGEON'S GLOVE is the device name listed in this FDA 510(k) record. The listed applicant is Baxter Healthcare Corp. It received FDA 510(k) clearance on 1991-09-11 under 510(k) number K913207. 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 TRIFLEX(R) POWDER FREE STERILE SURGEON'S GLOVE?

TRIFLEX(R) POWDER FREE STERILE SURGEON'S GLOVE is a medical device that received FDA 510(k) clearance on 1991-09-11. The listed applicant is Baxter Healthcare Corp. The 510(k) number is K913207.

When did TRIFLEX(R) POWDER FREE STERILE SURGEON'S GLOVE receive FDA 510(k) clearance?

TRIFLEX(R) POWDER FREE STERILE SURGEON'S GLOVE received FDA 510(k) clearance on 1991-09-11, under 510(k) number K913207.

Who is the listed applicant for TRIFLEX(R) POWDER FREE STERILE SURGEON'S GLOVE?

The FDA 510(k) record lists Baxter Healthcare Corp as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TRIFLEX(R) POWDER FREE STERILE SURGEON'S GLOVE?

The FDA product code for TRIFLEX(R) POWDER FREE STERILE SURGEON'S GLOVE is KGO.

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Other records listing Baxter Healthcare Corp as applicant

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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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