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FDA 510(k)

MEDICAL RUBBER GLOVES-STERILE-SURGEONS

K-Number: K831632 · 1984-07-23

ApplicantTagum Rubber Industries, Ltd.
Decision Date1984-07-23
Product CodeKGO
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MEDICAL RUBBER GLOVES-STERILE-SURGEONS is the device name listed in this FDA 510(k) record. The listed applicant is Tagum Rubber Industries, Ltd.. It received FDA 510(k) clearance on 1984-07-23 under 510(k) number K831632. 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 MEDICAL RUBBER GLOVES-STERILE-SURGEONS?

MEDICAL RUBBER GLOVES-STERILE-SURGEONS is a medical device that received FDA 510(k) clearance on 1984-07-23. The listed applicant is Tagum Rubber Industries, Ltd.. The 510(k) number is K831632.

When did MEDICAL RUBBER GLOVES-STERILE-SURGEONS receive FDA 510(k) clearance?

MEDICAL RUBBER GLOVES-STERILE-SURGEONS received FDA 510(k) clearance on 1984-07-23, under 510(k) number K831632.

Who is the listed applicant for MEDICAL RUBBER GLOVES-STERILE-SURGEONS?

The FDA 510(k) record lists Tagum Rubber Industries, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MEDICAL RUBBER GLOVES-STERILE-SURGEONS?

The FDA product code for MEDICAL RUBBER GLOVES-STERILE-SURGEONS 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 Tagum Rubber Industries, Ltd. 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.

K892073TAGUM LATEX 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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