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FDA 510(k)

LATEX SURGICAL GLOVE (NON STERILE)

K-Number: K883556 · 1989-02-03

ApplicantMakintech Corp.
Decision Date1989-02-03
Product CodeKGO
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

LATEX SURGICAL GLOVE (NON STERILE) is the device name listed in this FDA 510(k) record. The listed applicant is Makintech Corp.. It received FDA 510(k) clearance on 1989-02-03 under 510(k) number K883556. 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 LATEX SURGICAL GLOVE (NON STERILE)?

LATEX SURGICAL GLOVE (NON STERILE) is a medical device that received FDA 510(k) clearance on 1989-02-03. The listed applicant is Makintech Corp.. The 510(k) number is K883556.

When did LATEX SURGICAL GLOVE (NON STERILE) receive FDA 510(k) clearance?

LATEX SURGICAL GLOVE (NON STERILE) received FDA 510(k) clearance on 1989-02-03, under 510(k) number K883556.

Who is the listed applicant for LATEX SURGICAL GLOVE (NON STERILE)?

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

What is the FDA product code for LATEX SURGICAL GLOVE (NON STERILE)?

The FDA product code for LATEX SURGICAL GLOVE (NON STERILE) 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 Makintech 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.

K893176LATEX EXAMINATION 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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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