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)

BARRIER N95 PARTICULATE RESPIRATOR

K-Number: K102923 · 2010-11-19

ApplicantMolnlycke Health Care
Decision Date2010-11-19
Product CodeMSH
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

BARRIER N95 PARTICULATE RESPIRATOR is the device name listed in this FDA 510(k) record. The listed applicant is Molnlycke Health Care. It received FDA 510(k) clearance on 2010-11-19 under 510(k) number K102923. The device is classified under product code MSH. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BARRIER N95 PARTICULATE RESPIRATOR?

BARRIER N95 PARTICULATE RESPIRATOR is a medical device that received FDA 510(k) clearance on 2010-11-19. The listed applicant is Molnlycke Health Care. The 510(k) number is K102923.

When did BARRIER N95 PARTICULATE RESPIRATOR receive FDA 510(k) clearance?

BARRIER N95 PARTICULATE RESPIRATOR received FDA 510(k) clearance on 2010-11-19, under 510(k) number K102923.

Who is the listed applicant for BARRIER N95 PARTICULATE RESPIRATOR?

The FDA 510(k) record lists Molnlycke Health Care as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BARRIER N95 PARTICULATE RESPIRATOR?

The FDA product code for BARRIER N95 PARTICULATE RESPIRATOR is MSH.

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 Molnlycke Health Care 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.

K123892MEPILEX TRANSFER AGK122132AVANCE FOAM DRESSING KIT INCL. TRANSPARENT FILM, TRANSFER PAD (SMALL, MEDIUM, LARGE) AVANCE TRANSPARENT FILM AVANCE FOAMK100029MEPILEX BORDER AG DRESSINGK061554MEPILEX AG ABSORBENT SILICONE-COATED DRESSINGK050786BARRIER SURGICAL GOWNSK031131KLINIDRAPE SURGICAL DRAPES

View all 7 devices →

Related Devices (Code: MSH)

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.

K233022Halyard Fluidshield 3 N95 Particulate Filter Respirator and Surgical Mask with So Soft Lining, Orange, Regular and Small, Halyard Fluidshield 3 N95 Particulate Filter Respirator and Surgical Mask with Safety Seal and So Soft Lining, Orange, Regular and Small, Halyard Fluidshield 2 N95 Particulate Filter Respirator and Surgical Mask with So Soft Lining, White, Regular and SmallOwens & Minor (O&M) Halyard, Inc.K172963Master-Frank N95 Particulate RespiratorMaster & Frank Enterprise Co., Ltd.K1711163M™ VFlex™ Health Care Particulate Respirator and Surgical Mask , Models 1804/1804S3M HealthcareK160271N95 Particulate Respirator and Surgical Mask, Models TN01-11 and TN01-12San-M Package Co., Ltd.K1210693M VFLEX HEALTH CARE PARTICULATE RESPIRATOR AND SURGICAL MASK3M CompanyK102092PRO GEAR N95 PARTICULATE FILTER RESPIRATOR & SURGICAL MASK, REGULAR SIZE MODEL RP CERIESPrestige Ameritech

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.

↑