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FDA 510(k)

DERMASSIST FLUID RESISTANT SURGICAL MASK WITH WRAPAROUND VISOR

K-Number: K021546 · 2003-03-05

ApplicantCreative Contract (M) Sdn Bhd
Decision Date2003-03-05
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DERMASSIST FLUID RESISTANT SURGICAL MASK WITH WRAPAROUND VISOR is the device name listed in this FDA 510(k) record. The listed applicant is Creative Contract (M) Sdn Bhd. It received FDA 510(k) clearance on 2003-03-05 under 510(k) number K021546. 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 DERMASSIST FLUID RESISTANT SURGICAL MASK WITH WRAPAROUND VISOR?

DERMASSIST FLUID RESISTANT SURGICAL MASK WITH WRAPAROUND VISOR is a medical device that received FDA 510(k) clearance on 2003-03-05. The listed applicant is Creative Contract (M) Sdn Bhd. The 510(k) number is K021546.

When did DERMASSIST FLUID RESISTANT SURGICAL MASK WITH WRAPAROUND VISOR receive FDA 510(k) clearance?

DERMASSIST FLUID RESISTANT SURGICAL MASK WITH WRAPAROUND VISOR received FDA 510(k) clearance on 2003-03-05, under 510(k) number K021546.

Who is the listed applicant for DERMASSIST FLUID RESISTANT SURGICAL MASK WITH WRAPAROUND VISOR?

The FDA 510(k) record lists Creative Contract (M) Sdn Bhd as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DERMASSIST FLUID RESISTANT SURGICAL MASK WITH WRAPAROUND VISOR?

The FDA product code for DERMASSIST FLUID RESISTANT SURGICAL MASK WITH WRAPAROUND VISOR 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 Creative Contract (M) Sdn Bhd 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.

K021533DERMASSIST PROCEDURE MASK/SURGICAL MASKS (GREEN, BLUE, YELLOW, PINK, WHITE)K021539DERMASSIST FLUID RESISTANT SURGICAL MASK (ORANGE) AND PROCEDURE MASK WITH TIE-ON AND WITH EARLOOPS

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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