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FDA 510(k)

ORIENT, LATEX SURGICAL GLOVES, STERILE

K-Number: K884882 · 1989-05-24

ApplicantRosa Intl.
Decision Date1989-05-24
Product CodeKGO
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ORIENT, LATEX SURGICAL GLOVES, STERILE is the device name listed in this FDA 510(k) record. The listed applicant is Rosa Intl.. It received FDA 510(k) clearance on 1989-05-24 under 510(k) number K884882. 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 ORIENT, LATEX SURGICAL GLOVES, STERILE?

ORIENT, LATEX SURGICAL GLOVES, STERILE is a medical device that received FDA 510(k) clearance on 1989-05-24. The listed applicant is Rosa Intl.. The 510(k) number is K884882.

When did ORIENT, LATEX SURGICAL GLOVES, STERILE receive FDA 510(k) clearance?

ORIENT, LATEX SURGICAL GLOVES, STERILE received FDA 510(k) clearance on 1989-05-24, under 510(k) number K884882.

Who is the listed applicant for ORIENT, LATEX SURGICAL GLOVES, STERILE?

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

What is the FDA product code for ORIENT, LATEX SURGICAL GLOVES, STERILE?

The FDA product code for ORIENT, LATEX SURGICAL GLOVES, STERILE 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 Rosa Intl. 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.

K895558ORIENT, 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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