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FDA 510(k)

SAFETEX/SUNTEX STERILE SURGICAL LATEX GLOVES

K-Number: K900296 · 1990-03-14

ApplicantP.T. Latexindo Prautama
Decision Date1990-03-14
Product CodeKGO
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SAFETEX/SUNTEX STERILE SURGICAL LATEX GLOVES is the device name listed in this FDA 510(k) record. The listed applicant is P.T. Latexindo Prautama. It received FDA 510(k) clearance on 1990-03-14 under 510(k) number K900296. 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 SAFETEX/SUNTEX STERILE SURGICAL LATEX GLOVES?

SAFETEX/SUNTEX STERILE SURGICAL LATEX GLOVES is a medical device that received FDA 510(k) clearance on 1990-03-14. The listed applicant is P.T. Latexindo Prautama. The 510(k) number is K900296.

When did SAFETEX/SUNTEX STERILE SURGICAL LATEX GLOVES receive FDA 510(k) clearance?

SAFETEX/SUNTEX STERILE SURGICAL LATEX GLOVES received FDA 510(k) clearance on 1990-03-14, under 510(k) number K900296.

Who is the listed applicant for SAFETEX/SUNTEX STERILE SURGICAL LATEX GLOVES?

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

What is the FDA product code for SAFETEX/SUNTEX STERILE SURGICAL LATEX GLOVES?

The FDA product code for SAFETEX/SUNTEX STERILE SURGICAL LATEX 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. Latexindo Prautama 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.

K910631SUNTEX STERILE EXAM GLOVESK892478SAFETEX & SUNTEX PATIENT 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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