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FDA 510(k)

STERILE POWDER FREE NITRILE SURGEONS GLOVES (NATURAL, BLUE AND GREEN)

K-Number: K981947 · 1999-03-03

ApplicantBoston Medical Corp.
Decision Date1999-03-03
Product CodeKGO
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

STERILE POWDER FREE NITRILE SURGEONS GLOVES (NATURAL, BLUE AND GREEN) is the device name listed in this FDA 510(k) record. The listed applicant is Boston Medical Corp.. It received FDA 510(k) clearance on 1999-03-03 under 510(k) number K981947. 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 STERILE POWDER FREE NITRILE SURGEONS GLOVES (NATURAL, BLUE AND GREEN)?

STERILE POWDER FREE NITRILE SURGEONS GLOVES (NATURAL, BLUE AND GREEN) is a medical device that received FDA 510(k) clearance on 1999-03-03. The listed applicant is Boston Medical Corp.. The 510(k) number is K981947.

When did STERILE POWDER FREE NITRILE SURGEONS GLOVES (NATURAL, BLUE AND GREEN) receive FDA 510(k) clearance?

STERILE POWDER FREE NITRILE SURGEONS GLOVES (NATURAL, BLUE AND GREEN) received FDA 510(k) clearance on 1999-03-03, under 510(k) number K981947.

Who is the listed applicant for STERILE POWDER FREE NITRILE SURGEONS GLOVES (NATURAL, BLUE AND GREEN)?

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

What is the FDA product code for STERILE POWDER FREE NITRILE SURGEONS GLOVES (NATURAL, BLUE AND GREEN)?

The FDA product code for STERILE POWDER FREE NITRILE SURGEONS GLOVES (NATURAL, BLUE AND GREEN) is KGO.

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Other records listing Boston Medical Corp. 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.

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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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