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)

LABELING CHANGE TO SURGICAL FACE MASK

K-Number: K881910 · 1988-05-18

ApplicantLouis M. Gerson Co., Inc.
Decision Date1988-05-18
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

LABELING CHANGE TO SURGICAL FACE MASK is the device name listed in this FDA 510(k) record. The listed applicant is Louis M. Gerson Co., Inc.. It received FDA 510(k) clearance on 1988-05-18 under 510(k) number K881910. 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 LABELING CHANGE TO SURGICAL FACE MASK?

LABELING CHANGE TO SURGICAL FACE MASK is a medical device that received FDA 510(k) clearance on 1988-05-18. The listed applicant is Louis M. Gerson Co., Inc.. The 510(k) number is K881910.

When did LABELING CHANGE TO SURGICAL FACE MASK receive FDA 510(k) clearance?

LABELING CHANGE TO SURGICAL FACE MASK received FDA 510(k) clearance on 1988-05-18, under 510(k) number K881910.

Who is the listed applicant for LABELING CHANGE TO SURGICAL FACE MASK?

The FDA 510(k) record lists Louis M. Gerson Co., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LABELING CHANGE TO SURGICAL FACE MASK?

The FDA product code for LABELING CHANGE TO SURGICAL FACE MASK 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 Louis M. Gerson Co., 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.

K061375RESPIRATOR N95 PARTICULATE RESPIRATOR, MODEL 1730K050193GERSON 2130/31 TYPE N95 NIOSH CERTIFIED SURGICAL RESPIRATORK960778ISOLAIR APR TYPE N95K925185ISOLAIR 2 FLUID RESIST SURG/PROCE/CONE/EARLOOP MASK931288ISOLAIR 2 FULL FACE SPLASH GUARDK922507GERSON ISOLAIR APR PARTICULATE SURGICAL MASK

View all 8 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.

↑