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FDA 510(k)

SURGIFIT STERILE SURGICAL GLOVES

K-Number: K913215 · 1991-09-23

ApplicantHevealactics Intl. Sdn Bhd
Decision Date1991-09-23
Product CodeKGO
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SURGIFIT STERILE SURGICAL GLOVES is the device name listed in this FDA 510(k) record. The listed applicant is Hevealactics Intl. Sdn Bhd. It received FDA 510(k) clearance on 1991-09-23 under 510(k) number K913215. 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 SURGIFIT STERILE SURGICAL GLOVES?

SURGIFIT STERILE SURGICAL GLOVES is a medical device that received FDA 510(k) clearance on 1991-09-23. The listed applicant is Hevealactics Intl. Sdn Bhd. The 510(k) number is K913215.

When did SURGIFIT STERILE SURGICAL GLOVES receive FDA 510(k) clearance?

SURGIFIT STERILE SURGICAL GLOVES received FDA 510(k) clearance on 1991-09-23, under 510(k) number K913215.

Who is the listed applicant for SURGIFIT STERILE SURGICAL GLOVES?

The FDA 510(k) record lists Hevealactics Intl. Sdn Bhd as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SURGIFIT STERILE SURGICAL GLOVES?

The FDA product code for SURGIFIT STERILE SURGICAL 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 Hevealactics Intl. Sdn Bhd 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.

K912405LATEX PROPHYLACTIC (CONDOM)

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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