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FDA 510(k)

MEDI PLUS SURGEON'S GLOVES

K-Number: K945363 · 1995-03-07

ApplicantP.T. Saptindo Surgica
Decision Date1995-03-07
Product CodeKGO
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MEDI PLUS SURGEON'S GLOVES is the device name listed in this FDA 510(k) record. The listed applicant is P.T. Saptindo Surgica. It received FDA 510(k) clearance on 1995-03-07 under 510(k) number K945363. 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 MEDI PLUS SURGEON'S GLOVES?

MEDI PLUS SURGEON'S GLOVES is a medical device that received FDA 510(k) clearance on 1995-03-07. The listed applicant is P.T. Saptindo Surgica. The 510(k) number is K945363.

When did MEDI PLUS SURGEON'S GLOVES receive FDA 510(k) clearance?

MEDI PLUS SURGEON'S GLOVES received FDA 510(k) clearance on 1995-03-07, under 510(k) number K945363.

Who is the listed applicant for MEDI PLUS SURGEON'S GLOVES?

The FDA 510(k) record lists P.T. Saptindo Surgica as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MEDI PLUS SURGEON'S GLOVES?

The FDA product code for MEDI PLUS SURGEON'S GLOVES 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing P.T. Saptindo Surgica 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.

K031670STERILE POWDER FREE LATEX SURGICAL GLOVE WITH POLYMER COATINGK031669STERILE POWDER FREE SYNTHETIC SURGICAL GLOVE WITH POLYMER COATING

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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