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FDA 510(k)

ESTEEM STERILE POLYISOPRENE SURGICAL GLOVES WITH COATING

K-Number: K031301 · 2003-10-15

Decision Date2003-10-15
Product CodeKGO
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ESTEEM STERILE POLYISOPRENE SURGICAL GLOVES WITH COATING is the device name listed in this FDA 510(k) record. The listed applicant is Cardinalhealth. It received FDA 510(k) clearance on 2003-10-15 under 510(k) number K031301. 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 ESTEEM STERILE POLYISOPRENE SURGICAL GLOVES WITH COATING?

ESTEEM STERILE POLYISOPRENE SURGICAL GLOVES WITH COATING is a medical device that received FDA 510(k) clearance on 2003-10-15. The listed applicant is Cardinalhealth. The 510(k) number is K031301.

When did ESTEEM STERILE POLYISOPRENE SURGICAL GLOVES WITH COATING receive FDA 510(k) clearance?

ESTEEM STERILE POLYISOPRENE SURGICAL GLOVES WITH COATING received FDA 510(k) clearance on 2003-10-15, under 510(k) number K031301.

Who is the listed applicant for ESTEEM STERILE POLYISOPRENE SURGICAL GLOVES WITH COATING?

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

What is the FDA product code for ESTEEM STERILE POLYISOPRENE SURGICAL GLOVES WITH COATING?

The FDA product code for ESTEEM STERILE POLYISOPRENE SURGICAL GLOVES WITH 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.

Other records listing Cardinalhealth 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.

View all 28 devices →

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.

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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