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FDA 510(k)

WHITE PLUME SURGICAL GAUZE FACE MASK

K-Number: K870312 · 1987-02-24

ApplicantChina National Medicines & Health Prod. I/E Corp.
Decision Date1987-02-24
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

WHITE PLUME SURGICAL GAUZE FACE MASK is the device name listed in this FDA 510(k) record. The listed applicant is China National Medicines & Health Prod. I/E Corp.. It received FDA 510(k) clearance on 1987-02-24 under 510(k) number K870312. 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 WHITE PLUME SURGICAL GAUZE FACE MASK?

WHITE PLUME SURGICAL GAUZE FACE MASK is a medical device that received FDA 510(k) clearance on 1987-02-24. The listed applicant is China National Medicines & Health Prod. I/E Corp.. The 510(k) number is K870312.

When did WHITE PLUME SURGICAL GAUZE FACE MASK receive FDA 510(k) clearance?

WHITE PLUME SURGICAL GAUZE FACE MASK received FDA 510(k) clearance on 1987-02-24, under 510(k) number K870312.

Who is the listed applicant for WHITE PLUME SURGICAL GAUZE FACE MASK?

The FDA 510(k) record lists China National Medicines & Health Prod. I/E Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for WHITE PLUME SURGICAL GAUZE FACE MASK?

The FDA product code for WHITE PLUME SURGICAL GAUZE FACE MASK is FXX.

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Other records listing China National Medicines & Health Prod. I/E Corp. 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.

K902324TP AND DESIGN, CONDOMK893351LATEX EXAMINATION GLOVES (MFG. ANHUI BENGBU LATEX)K892916PATIENT EXAMINATION GLOVES (LATEX)K891365LATEX EXAMINATION GLOVES, NON-STERILEK870309WHITE PLUME ABSORBENT COTTON WOOLK870315WHITE PLUME ABSORBENT BANDAGE

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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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