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FDA 510(k)

PROTEKT GLOVES

K-Number: K910920 · 1991-05-15

ApplicantIntermedics Orthopedics
Decision Date1991-05-15
Product CodeFYE
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PROTEKT GLOVES is the device name listed in this FDA 510(k) record. The listed applicant is Intermedics Orthopedics. It received FDA 510(k) clearance on 1991-05-15 under 510(k) number K910920. The device is classified under product code FYE. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PROTEKT GLOVES?

PROTEKT GLOVES is a medical device that received FDA 510(k) clearance on 1991-05-15. The listed applicant is Intermedics Orthopedics. The 510(k) number is K910920.

When did PROTEKT GLOVES receive FDA 510(k) clearance?

PROTEKT GLOVES received FDA 510(k) clearance on 1991-05-15, under 510(k) number K910920.

Who is the listed applicant for PROTEKT GLOVES?

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

What is the FDA product code for PROTEKT GLOVES?

The FDA product code for PROTEKT GLOVES is FYE.

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Other records listing Intermedics Orthopedics as applicant

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Related Devices (Code: FYE)

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.

K932731BARRIER* EXTRA PROTECTION PLUS SURGICAL GOWNJohnson & Johnson Medical, Inc.K912790SURGICAL GOWNUnicor Federal Dept. of JusticeK910941LIFELINER SURGICAL GLOVEDepuy-RaynhamK895667STERILE SURGICAL GOWNClinitech, Inc.K895235VARIOUS DISPOSABLE SURGICAL GARMENTSProtect Corp. of Indiana, Inc.K894760CLOTHINGUARDBarrier Concepts, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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