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FDA 510(k)

NEUTRALON SURGICAL GLOVES

K-Number: K861441 · 1986-05-30

ApplicantSurgikos, Inc.
Decision Date1986-05-30
Product CodeKGO
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

NEUTRALON SURGICAL GLOVES is the device name listed in this FDA 510(k) record. The listed applicant is Surgikos, Inc.. It received FDA 510(k) clearance on 1986-05-30 under 510(k) number K861441. 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 NEUTRALON SURGICAL GLOVES?

NEUTRALON SURGICAL GLOVES is a medical device that received FDA 510(k) clearance on 1986-05-30. The listed applicant is Surgikos, Inc.. The 510(k) number is K861441.

When did NEUTRALON SURGICAL GLOVES receive FDA 510(k) clearance?

NEUTRALON SURGICAL GLOVES received FDA 510(k) clearance on 1986-05-30, under 510(k) number K861441.

Who is the listed applicant for NEUTRALON SURGICAL GLOVES?

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

What is the FDA product code for NEUTRALON SURGICAL GLOVES?

The FDA product code for NEUTRALON SURGICAL GLOVES is KGO.

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Other records listing Surgikos, 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.

K875107HEALTH CARE EYE PROTECTIONK874653STERILE SURGICAL SCRUB BRUSHK852870BARRIER SURGICAL GOWNK822535CIDEX*DIALYZER DISINFECTING SOLUTIONK820543BARRIER ANTIMICROBIAL INCISE DRAPEK820542SURGIKOS INCISE DRAPE

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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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