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FDA 510(k)

TRIFLEX ORTHOPEDIC STERILE SURGEON'S GLOVE

K-Number: K902380 · 1990-06-18

Decision Date1990-06-18
Product CodeKGO
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

TRIFLEX ORTHOPEDIC STERILE SURGEON'S GLOVE is the device name listed in this FDA 510(k) record. The listed applicant is Baxter Healthcare Corp. It received FDA 510(k) clearance on 1990-06-18 under 510(k) number K902380. 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 TRIFLEX ORTHOPEDIC STERILE SURGEON'S GLOVE?

TRIFLEX ORTHOPEDIC STERILE SURGEON'S GLOVE is a medical device that received FDA 510(k) clearance on 1990-06-18. The listed applicant is Baxter Healthcare Corp. The 510(k) number is K902380.

When did TRIFLEX ORTHOPEDIC STERILE SURGEON'S GLOVE receive FDA 510(k) clearance?

TRIFLEX ORTHOPEDIC STERILE SURGEON'S GLOVE received FDA 510(k) clearance on 1990-06-18, under 510(k) number K902380.

Who is the listed applicant for TRIFLEX ORTHOPEDIC STERILE SURGEON'S GLOVE?

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

What is the FDA product code for TRIFLEX ORTHOPEDIC STERILE SURGEON'S GLOVE?

The FDA product code for TRIFLEX ORTHOPEDIC STERILE SURGEON'S GLOVE 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 Baxter Healthcare Corp 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.

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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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