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FDA 510(k)

BARRIER* EXTRA PROTECTION PLUS SURGICAL GOWN

K-Number: K932731 · 1994-04-11

ApplicantJohnson & Johnson Medical, Inc.
Decision Date1994-04-11
Product CodeFYE
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

BARRIER* EXTRA PROTECTION PLUS SURGICAL GOWN is the device name listed in this FDA 510(k) record. The listed applicant is Johnson & Johnson Medical, Inc.. It received FDA 510(k) clearance on 1994-04-11 under 510(k) number K932731. 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 BARRIER* EXTRA PROTECTION PLUS SURGICAL GOWN?

BARRIER* EXTRA PROTECTION PLUS SURGICAL GOWN is a medical device that received FDA 510(k) clearance on 1994-04-11. The listed applicant is Johnson & Johnson Medical, Inc.. The 510(k) number is K932731.

When did BARRIER* EXTRA PROTECTION PLUS SURGICAL GOWN receive FDA 510(k) clearance?

BARRIER* EXTRA PROTECTION PLUS SURGICAL GOWN received FDA 510(k) clearance on 1994-04-11, under 510(k) number K932731.

Who is the listed applicant for BARRIER* EXTRA PROTECTION PLUS SURGICAL GOWN?

The FDA 510(k) record lists Johnson & Johnson Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BARRIER* EXTRA PROTECTION PLUS SURGICAL GOWN?

The FDA product code for BARRIER* EXTRA PROTECTION PLUS SURGICAL GOWN is FYE.

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Other records listing Johnson & Johnson Medical, Inc. 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.

K001690PROTECTIV SAFETY BLOOD COLLECTION NEEDLEK982641ADVANCED NIBP MODULEK983362NU-GEL * WOUND DRESSINGK982597FIBRCOL PLUS COLLAGEN WOUND DRESSING WITH ALGINATEK974080CRITIKON SOFT BLOOD PRESSURE CUFFK980493I.V. CATHETER SYSTEM

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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.

K912790SURGICAL GOWNUnicor Federal Dept. of JusticeK910920PROTEKT GLOVESIntermedics OrthopedicsK910941LIFELINER 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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