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FDA 510(k)

STERILE POWDER FREE SYNTHETIC SURGICAL GLOVE WITH POLYMER COATING

K-Number: K031669 · 2003-09-23

ApplicantP.T. Saptindo Surgica
Decision Date2003-09-23
Product CodeKGO
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

STERILE POWDER FREE SYNTHETIC SURGICAL GLOVE WITH POLYMER COATING 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 2003-09-23 under 510(k) number K031669. 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 SYNTHETIC SURGICAL GLOVE WITH POLYMER COATING?

STERILE POWDER FREE SYNTHETIC SURGICAL GLOVE WITH POLYMER COATING is a medical device that received FDA 510(k) clearance on 2003-09-23. The listed applicant is P.T. Saptindo Surgica. The 510(k) number is K031669.

When did STERILE POWDER FREE SYNTHETIC SURGICAL GLOVE WITH POLYMER COATING receive FDA 510(k) clearance?

STERILE POWDER FREE SYNTHETIC SURGICAL GLOVE WITH POLYMER COATING received FDA 510(k) clearance on 2003-09-23, under 510(k) number K031669.

Who is the listed applicant for STERILE POWDER FREE SYNTHETIC SURGICAL GLOVE WITH POLYMER COATING?

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 STERILE POWDER FREE SYNTHETIC SURGICAL GLOVE WITH POLYMER COATING?

The FDA product code for STERILE POWDER FREE SYNTHETIC SURGICAL GLOVE WITH POLYMER COATING 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 COATINGK945363MEDI PLUS SURGEON'S 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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