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FDA 510(k)

PRIMAGARD Isolation Gown (AAMI PB70 Level 3)

K-Number: K160361 · 2016-11-04

ApplicantPrimed Medical Products, Inc.
Decision Date2016-11-04
Product CodeFYC
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PRIMAGARD Isolation Gown (AAMI PB70 Level 3) is a medical device manufactured by Primed Medical Products, Inc.. It received FDA 510(k) clearance on 2016-11-04 under approval number K160361. The device is classified under product code FYC. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PRIMAGARD Isolation Gown (AAMI PB70 Level 3)?

PRIMAGARD Isolation Gown (AAMI PB70 Level 3) is a medical device that received FDA 510(k) clearance on 2016-11-04. It is manufactured by Primed Medical Products, Inc.. The 510(k) number is K160361.

When was PRIMAGARD Isolation Gown (AAMI PB70 Level 3) approved by the FDA?

PRIMAGARD Isolation Gown (AAMI PB70 Level 3) received FDA 510(k) clearance on 2016-11-04, under approval number K160361.

What company makes PRIMAGARD Isolation Gown (AAMI PB70 Level 3)?

PRIMAGARD Isolation Gown (AAMI PB70 Level 3) is manufactured by Primed Medical Products, Inc..

What is the FDA product code for PRIMAGARD Isolation Gown (AAMI PB70 Level 3)?

The FDA product code for PRIMAGARD Isolation Gown (AAMI PB70 Level 3) is FYC.

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Other Devices by Primed Medical Products, Inc.

K213427PRIMED Pediatric Facemask K242208PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600) K240286PRIMED Surgical Masks and PRIMED Procedure Masks K233777PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600) K252964PRIMED Surgical and Procedure Masks

Related Devices (Code: FYC)

K160339Cardinal Health Isolation GownCardinal Health200, LLC K160471Medline Non-Surgical Isolation Gown-Medline Industries, Inc. K171535SURGICAL ISOLATION GOWNJingzhou Haixin Green Cross Medical Products Co., Ltd. K190306AMD Ritmed AssureWear VersaGownAmd Medicom, Inc. K212633Disposable Isolation Gown -Level 3, Large, Blue, Disposable Isolation Gown - Level 3, X-Large, BlueString King Lacrosse, LLC K211538Protect X Level 3 Isolation GownAzac Group

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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