Atlas FDA

N95 Particulate Respirator and Surgical Mask, Models TN01-11 and TN01-12

FDA 510(k) clearance K160271 · decided 2016-07-15

Clearance details

K-number
K160271
Device name
N95 Particulate Respirator and Surgical Mask, Models TN01-11 and TN01-12
Applicant
San-M Package Co., Ltd.
Decision
Substantially Equivalent
Date received
2016-02-02
Decision date
2016-07-15
Days to decision
164 days
Clearance type
Abbreviated
Product code
MSH
Device class
2
Regulation number
878.4040
Medical specialty
General, Plastic Surgery
Advisory committee
General, Plastic Surgery
Location
Shimada-City, JP
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
Halyard 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 Small (K233022)Owens & Minor (O&M) Halyard, Inc.2024-01-12
Master-Frank N95 Particulate Respirator (K172963)Master & Frank Enterprise Co., Ltd.2018-04-04
3M™ VFlex™ Health Care Particulate Respirator and Surgical Mask , Models 1804/1804S (K171116)3M Healthcare2017-08-10
Pasture F550S Surgical N95 Respirator, Pasture F550CS Surgical N95 Respirator, Pasture A520S Surgical N95 Respirator, Pasture A520CS Surgical N95 Respirator, Pasture E520S Surgical N95 Respirator, Pasture E520CS Surgical N95 Respirator (K141876)Pasture Pharma Pte, Ltd.2015-10-28
3M VFLEX HEALTH CARE PARTICULATE RESPIRATOR AND SURGICAL MASK (K121069)3M Company2013-02-11
BARRIER N95 PARTICULATE RESPIRATOR (K102923)Molnlycke Health Care2010-11-19
PRO GEAR N95 PARTICULATE FILTER RESPIRATOR & SURGICAL MASK, REGULAR SIZE MODEL RP CERIES (K102092)Prestige Ameritech2010-10-06
MOLDEX-METRIC HEALTH CARE N95 PARTICULATE RESPIRATOR AND SURGICAL MASK, MODEL 1712 (K102173)Moldex/Metric, Inc.2010-09-13
SAFE LIFE N95 RESPIRATOR AND SURGICAL MASK, MODELS B130 AND B150 (K100139)Safelife Corp.2010-05-04
N95 RESPIRATOR MASK, POSITIVE FACIAL LOCK WITH MAGIC ARCH, MODEL 695 (K092824)Alpha Protech, Inc.2009-10-21
DS N95 SURGICAL MASKS AND FLAT SURGICAL (K090131)Shanghai Dasheng Health Products2009-04-27
HANDAN N95 PARTICULATE RESPIRATORS AND SURGICAL MASK, MODELS HY8510 AND HY9810 (K080827)Handan Hengyong Protective & Clean Products Co., L2008-04-04

Recalls involving this device

No recalls on record reference this clearance.