Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

TECNOL FLUID SHIELD SURGICAL MASK W/EYEGUARD

K-Number: K880757 · 1988-03-11

ApplicantTecnol New Jersey Wound Care, Inc.
Decision Date1988-03-11
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

TECNOL FLUID SHIELD SURGICAL MASK W/EYEGUARD is the device name listed in this FDA 510(k) record. The listed applicant is Tecnol New Jersey Wound Care, Inc.. It received FDA 510(k) clearance on 1988-03-11 under 510(k) number K880757. 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 TECNOL FLUID SHIELD SURGICAL MASK W/EYEGUARD?

TECNOL FLUID SHIELD SURGICAL MASK W/EYEGUARD is a medical device that received FDA 510(k) clearance on 1988-03-11. The listed applicant is Tecnol New Jersey Wound Care, Inc.. The 510(k) number is K880757.

When did TECNOL FLUID SHIELD SURGICAL MASK W/EYEGUARD receive FDA 510(k) clearance?

TECNOL FLUID SHIELD SURGICAL MASK W/EYEGUARD received FDA 510(k) clearance on 1988-03-11, under 510(k) number K880757.

Who is the listed applicant for TECNOL FLUID SHIELD SURGICAL MASK W/EYEGUARD?

The FDA 510(k) record lists Tecnol New Jersey Wound Care, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TECNOL FLUID SHIELD SURGICAL MASK W/EYEGUARD?

The FDA product code for TECNOL FLUID SHIELD SURGICAL MASK W/EYEGUARD is FXX.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Tecnol New Jersey Wound Care, 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.

K913043MODIFICATION TECNOL FLUIDSHIELD SURGICAL MASKSK911891FLUIDSHIELD(TM) CONE CLASSIC(TM) II SURGICAL MASKK911907FLUIDSHIELD CONE CLASSIC II SURG MASK W/SPLASH VISK896193TECNOL LAZER(TM) SURGICAL MASKK894205TECNOL SILK STRIPK893702TECNOL GAITERS PRODUCT NUMBER 47725-010

View all 35 devices →

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.

↑