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FDA 510(k)

SOLUTION FACE MASKS

K-Number: K031353 · 2003-06-19

ApplicantA Plus International, Inc.
Decision Date2003-06-19
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SOLUTION FACE MASKS is the device name listed in this FDA 510(k) record. The listed applicant is A Plus International, Inc.. It received FDA 510(k) clearance on 2003-06-19 under 510(k) number K031353. 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 SOLUTION FACE MASKS?

SOLUTION FACE MASKS is a medical device that received FDA 510(k) clearance on 2003-06-19. The listed applicant is A Plus International, Inc.. The 510(k) number is K031353.

When did SOLUTION FACE MASKS receive FDA 510(k) clearance?

SOLUTION FACE MASKS received FDA 510(k) clearance on 2003-06-19, under 510(k) number K031353.

Who is the listed applicant for SOLUTION FACE MASKS?

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

What is the FDA product code for SOLUTION FACE MASKS?

The FDA product code for SOLUTION FACE MASKS is FXX.

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Other records listing A Plus International, 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.

K213001Procedure Mask, Surgical MaskK102861SURGIPLUS SMS SURGICAL DRAPE (STERILE/NON-STERILE), SURGIPLUS SPP WITH PE LAMINATED SURGICAL DRAPE (STERILE/NON-STERILE)K093169SURGIPLUS STANDARD SURGICAL GOWN (STERILE) ( NON STERILE), REINFORCED SURGICAL GOWN (STERILE) (NON STERILE)K882281GOWN, ISOLATION, SURGICAL (FYC)K882284SURGEONS CAPK882283BOUFFANT CAP

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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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