FDA 510(k)

PRIMAGARD 80, 120, 160 FLUID RESISTANT PROCEDURE/SURGICAL FACE MASKS

K-Number: K081633 · 2008-08-11

Decision Date2008-08-11

Product CodeFXX

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

PRIMAGARD 80, 120, 160 FLUID RESISTANT PROCEDURE/SURGICAL FACE MASKS is the device name listed in this FDA 510(k) record. The listed applicant is Primed Medical Products, Inc.. It received FDA 510(k) clearance on 2008-08-11 under 510(k) number K081633. The device is classified under product code FXX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PRIMAGARD 80, 120, 160 FLUID RESISTANT PROCEDURE/SURGICAL FACE MASKS?

PRIMAGARD 80, 120, 160 FLUID RESISTANT PROCEDURE/SURGICAL FACE MASKS is a medical device that received FDA 510(k) clearance on 2008-08-11. The listed applicant is Primed Medical Products, Inc.. The 510(k) number is K081633.

When did PRIMAGARD 80, 120, 160 FLUID RESISTANT PROCEDURE/SURGICAL FACE MASKS receive FDA 510(k) clearance?

PRIMAGARD 80, 120, 160 FLUID RESISTANT PROCEDURE/SURGICAL FACE MASKS received FDA 510(k) clearance on 2008-08-11, under 510(k) number K081633.

Who is the listed applicant for PRIMAGARD 80, 120, 160 FLUID RESISTANT PROCEDURE/SURGICAL FACE MASKS?

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

What is the FDA product code for PRIMAGARD 80, 120, 160 FLUID RESISTANT PROCEDURE/SURGICAL FACE MASKS?

The FDA product code for PRIMAGARD 80, 120, 160 FLUID RESISTANT PROCEDURE/SURGICAL FACE MASKS is FXX.

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Other records listing Primed Medical Products, Inc. as applicant

K262007PRIMED AAMI Level 3 Open Back Gowns K261811PRIMED Chemotherapy Drug Tested Gowns (PM4-99450: PRIMED Chemotherapy Drug Tested Isolation Gown, Purple, AAMI Level 2; PM4-99460: PRIMED Chemotherapy Drug Tested Isolation Gown, Blue, AAMI Level 3)K252964PRIMED Surgical and Procedure Masks 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)

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Related Devices (Code: FXX)

K251967HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops; HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops with WrapAround VisorO&M Halyard, Inc.K252534Surgical Face Mask (Ear mount)Zhejiang Hangkang Medical Equipment Co., Ltd.K253398Disposable Surgical Mask (Non-Sterile) (EFX3PLBLKMSK300)Efofex, Inc.K252830Disposable Surgical Face Mask (3P00B, C2900)Beatles Medical Supplies (Xiantao) Co., Ltd.K252650Disposable Medical Face MaskMakrite Industries, Inc.K243342KP Protective Face MaskKp Trading Co., Ltd.

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.