FDA 510(k)

PRO GEAR N95 PARTICULATE FILTER RESPIRATOR & SURGICAL MASK, REGULAR SIZE MODEL RP CERIES

K-Number: K102092 · 2010-10-06

Decision Date2010-10-06

Product CodeMSH

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

PRO GEAR N95 PARTICULATE FILTER RESPIRATOR & SURGICAL MASK, REGULAR SIZE MODEL RP CERIES is the device name listed in this FDA 510(k) record. The listed applicant is Prestige Ameritech. It received FDA 510(k) clearance on 2010-10-06 under 510(k) number K102092. 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 PRO GEAR N95 PARTICULATE FILTER RESPIRATOR & SURGICAL MASK, REGULAR SIZE MODEL RP CERIES?

PRO GEAR N95 PARTICULATE FILTER RESPIRATOR & SURGICAL MASK, REGULAR SIZE MODEL RP CERIES is a medical device that received FDA 510(k) clearance on 2010-10-06. The listed applicant is Prestige Ameritech. The 510(k) number is K102092.

When did PRO GEAR N95 PARTICULATE FILTER RESPIRATOR & SURGICAL MASK, REGULAR SIZE MODEL RP CERIES receive FDA 510(k) clearance?

PRO GEAR N95 PARTICULATE FILTER RESPIRATOR & SURGICAL MASK, REGULAR SIZE MODEL RP CERIES received FDA 510(k) clearance on 2010-10-06, under 510(k) number K102092.

Who is the listed applicant for PRO GEAR N95 PARTICULATE FILTER RESPIRATOR & SURGICAL MASK, REGULAR SIZE MODEL RP CERIES?

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

What is the FDA product code for PRO GEAR N95 PARTICULATE FILTER RESPIRATOR & SURGICAL MASK, REGULAR SIZE MODEL RP CERIES?

The FDA product code for PRO GEAR N95 PARTICULATE FILTER RESPIRATOR & SURGICAL MASK, REGULAR SIZE MODEL RP CERIES is MSH.

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Other records listing Prestige Ameritech as applicant

K231741ProGear® Surgical Mask with Oxafence®, Model AV82030 K171162Surgical Earloop Face Mask with Bottom Gap Shield and Surgical Tie-On Face Mask with Bottom Gap Shield K160100Prestige Ameritech Pediatric/Child’s Face mask K061716PRESTIGE AMERITECH FACE MASK

Related Devices (Code: MSH)

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 Healthcare K160271N95 Particulate Respirator and Surgical Mask, Models TN01-11 and TN01-12San-M Package Co., Ltd.K1210693M VFLEX HEALTH CARE PARTICULATE RESPIRATOR AND SURGICAL MASK3M Company K102923BARRIER N95 PARTICULATE RESPIRATORMolnlycke Health Care

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.