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FDA 510(k)

BARRIERPLUS PLATINUM POWDER-FREE SYNTHETIC POLYCHLOROPRENE SURGICAL GLOVES, MODELS 12544-125490

K-Number: K061038 · 2006-06-23

ApplicantBarriermed Glove Co.
Decision Date2006-06-23
Product CodeKGO
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

BARRIERPLUS PLATINUM POWDER-FREE SYNTHETIC POLYCHLOROPRENE SURGICAL GLOVES, MODELS 12544-125490 is the device name listed in this FDA 510(k) record. The listed applicant is Barriermed Glove Co.. It received FDA 510(k) clearance on 2006-06-23 under 510(k) number K061038. 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 BARRIERPLUS PLATINUM POWDER-FREE SYNTHETIC POLYCHLOROPRENE SURGICAL GLOVES, MODELS 12544-125490?

BARRIERPLUS PLATINUM POWDER-FREE SYNTHETIC POLYCHLOROPRENE SURGICAL GLOVES, MODELS 12544-125490 is a medical device that received FDA 510(k) clearance on 2006-06-23. The listed applicant is Barriermed Glove Co.. The 510(k) number is K061038.

When did BARRIERPLUS PLATINUM POWDER-FREE SYNTHETIC POLYCHLOROPRENE SURGICAL GLOVES, MODELS 12544-125490 receive FDA 510(k) clearance?

BARRIERPLUS PLATINUM POWDER-FREE SYNTHETIC POLYCHLOROPRENE SURGICAL GLOVES, MODELS 12544-125490 received FDA 510(k) clearance on 2006-06-23, under 510(k) number K061038.

Who is the listed applicant for BARRIERPLUS PLATINUM POWDER-FREE SYNTHETIC POLYCHLOROPRENE SURGICAL GLOVES, MODELS 12544-125490?

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

What is the FDA product code for BARRIERPLUS PLATINUM POWDER-FREE SYNTHETIC POLYCHLOROPRENE SURGICAL GLOVES, MODELS 12544-125490?

The FDA product code for BARRIERPLUS PLATINUM POWDER-FREE SYNTHETIC POLYCHLOROPRENE SURGICAL GLOVES, MODELS 12544-125490 is KGO.

Related Clinical Trials

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 Barriermed Glove Co. 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.

K053406BARRIERPLUS GOLD POWDER-FREE SYNTHETIC POLYISOPRENE SURGICAL GLOVESK052772BARRIERPLUS GOLD ORTHO POWDER-FREE SYNTHETIC POLYISOPRENE ORTHOPEDIC SURGICAL GLOVESK052892SYNTHALON PC PLUS POWDER-FREE POLYCHLOROPRENE EXAMINATION GLOVES, MODELS 1372-11 TO 1272-55K990710BARRIERPLUS SYNTHETIC POWDER-FREE SURGICAL GLOVES

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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