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FDA 510(k)

MEDLINE PROHIBIT SERIES SURGICAL MASK WITH FLUID SHIELD

K-Number: K991559 · 1999-08-23

ApplicantMedline Industries, Inc.
Decision Date1999-08-23
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MEDLINE PROHIBIT SERIES SURGICAL MASK WITH FLUID SHIELD is the device name listed in this FDA 510(k) record. The listed applicant is Medline Industries, Inc.. It received FDA 510(k) clearance on 1999-08-23 under 510(k) number K991559. 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 MEDLINE PROHIBIT SERIES SURGICAL MASK WITH FLUID SHIELD?

MEDLINE PROHIBIT SERIES SURGICAL MASK WITH FLUID SHIELD is a medical device that received FDA 510(k) clearance on 1999-08-23. The listed applicant is Medline Industries, Inc.. The 510(k) number is K991559.

When did MEDLINE PROHIBIT SERIES SURGICAL MASK WITH FLUID SHIELD receive FDA 510(k) clearance?

MEDLINE PROHIBIT SERIES SURGICAL MASK WITH FLUID SHIELD received FDA 510(k) clearance on 1999-08-23, under 510(k) number K991559.

Who is the listed applicant for MEDLINE PROHIBIT SERIES SURGICAL MASK WITH FLUID SHIELD?

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

What is the FDA product code for MEDLINE PROHIBIT SERIES SURGICAL MASK WITH FLUID SHIELD?

The FDA product code for MEDLINE PROHIBIT SERIES SURGICAL MASK WITH FLUID SHIELD is FXX.

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Related Devices (Code: FXX)

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.

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

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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