Product Code: FYA


Products Classified as FYA

2815Gown, SurgicalSurgical Apparel.

Total Product Life Cycle (TPLC) Devices

2815Gown, SurgicalSurgical Apparel.

FDA Consensus Standards

Gown, Surgical [32348]21 CFR §878.4040 🔎
Gown, Surgical [36974]21 CFR §878.4040 🔎
Gown, Surgical [32435]21 CFR §878.4040 🔎
Gown, Surgical [30973]21 CFR §878.4040 🔎
Gown, Surgical [31764]21 CFR §878.4040 🔎

Pre-market Notifications for FYA

K221977Disposable Surgical Gown (G4003)Xiantao Topmed Nonwoven Protective Products Co., Ltd.
K221637Surgical Gown (Sterile); Surgical Gown (Non-sterile)Allmed Medical (Hubei) Protective Products Co., Ltd
K221139Bodygard SFS Surgical Gown Level 4Feliks Plastik Laminasyon Ve Ambalaj Malzemeleri
K220665Surgical Gown, Blue, Sterile; Surgical Gown, Blue, Non-SterileExcellent Medical Technology Group Co., Ltd.
K220333Medline Orbis LVL 3 Surgical GownMedline Industries, LP.
K220092YADU Surgical GownsHeNan YADU Industrial Co., Ltd.
K214108Medline Orbis Chemo Surgical GownMedline Industries LP
K213703Surgical GownWujiang Tutaike Textiles & Finishing Co., Ltd.
K213177Plus Medical Cover GownFoshan Nanhai Plus Medical CO LTD
K212861Surgical Gown, Reinforced Surgical GownWuhan Zonsen Medical Products Co.,Ltd
K212812Surgical GownXianning Marveldas Protective Articles CO.,Ltd.
K212718Surgical GownsXiantao Dingcheng Non-Woven Product Co., Ltd
K211509Surgical GownHubei Wanli Protective Products Co. Ltd
K211422Level 2 Standard Surgical Gown, Level 3 Standard Surgical Gown, Level 3 Reinforced Surgical GownJiangsu Medplus Non-woven Manufacturer Co., Ltd.
K211399Sterile & Non-Sterile Level 3 Surgical Gown, Sterile & Non-Sterile Level 4 Surgical Gown, Sterile & Non-Sterile Level 4 Surgical Isolation GownBarco Tekstil Sanayi Ve Ticaret A.S.

Global Unique Device Identification Database

10612899134055GOWN, SURGICAL
10612899134048GOWN, SURGICAL
10612899134031GOWN, SURGICAL
50609953926488GOWN, SURGICAL
50609953926457GOWN, SURGICAL
50609953926426GOWN, SURGICAL
50609953916014GOWN, SURGICAL
50609953915956GOWN, SURGICAL
50609953915628GOWN, SURGICAL
50609953915574GOWN, SURGICAL
50609953915529GOWN, SURGICAL
50609953600920GOWN, SURGICAL
50609953600845GOWN, SURGICAL
50609953498466GOWN, SURGICAL
50609953472589GOWN, SURGICAL

Maude Adverse Events

CONVERTORSCARDINAL HEALTH 200, LLC2020-03-26
AAMI 4 SMARTSLEEVE SURG GOWN LGCARDINAL HEALTH SINGAPORE 225 PTE. LTD.2020-03-25
CONVERTORSCARDINAL HEALTH 200, LLC2020-03-20
HALYARD GOWN SURG NON-REINFORCEDHALYARD HEALTH2020-03-10
SIRUS SURGICAL GOWNMEDLINE INDUSTRIES, INC.2020-02-18
FLYTE SURGICOOL TOGA, 2XL, ZIPPERSTRYKER INSTRUMENTS-KALAMAZOO2020-02-11
GOWN, SURGICALNOVO HEALTH SERVICES2020-02-10
CONVERTORS SURGICAL GOWNCARDINAL HEALTH 200, LLC2020-02-07
GOWN, SURGICAL L2NOVO HEALTH SERVICES, LLC2020-02-04
AERO CHROME BREATHABLE PERFORMANCE GOWNO&M HALYARD, INC.2020-02-03
FLYTE SURGICOOL TOGA, 2XL, ZIPPER, PEELAWAYSTRYKER INSTRUMENTS-KALAMAZOO2020-01-28
BARIATRIC PACK GOWNMEDLINE INDUSTRIES, INC.2020-01-21
GENERAL LAPAROSCOPY-LF GOWNMEDLINE INDUSTRIES, INC.2020-01-17
GOWN, SURGICAL L3NOVO HEALTH SERVICES2019-11-21
FLYTE, SURGICOOLSTRYKER INSTRUMENTS2019-11-18
MEDLINE SURGICAL GOWNMEDLINE INDUSTRIES, INC.2019-09-03
UNKNOWN_INSTRUMENTS_PRODUCTSTRYKER INSTRUMENTS-KALAMAZOO2019-07-26
FLYTE SURGICOOL ZIPPERED TOGASTRYKER CORPORATION2019-07-25
T4 ZIPPER TOGA, XLSTRYKER INSTRUMENTS-KALAMAZOO2019-07-23
T4 HOODSTRYKER INSTRUMENTS-KALAMAZOO2019-07-23
UNKNOWN_INSTRUMENTS_PRODUCTSTRYKER INSTRUMENTS-KALAMAZOO2019-06-18
UNKNOWN_INSTRUMENTS_PRODUCTSTRYKER INSTRUMENTS-KALAMAZOO2019-06-18
CONVERTORSCARDINAL HEALTH 200, LLC2019-06-05
GOWN, SURGICALCARDINAL HEALTH2019-05-03
GOWN, SURGICALCARDINAL HEALTH, INC.2019-05-03
GOWN, SURGICALCARDINAL HEALTH 200, LLC2019-05-03
FLYTE SURGICOOL ZIPPERED TOGASTRYKER INSTRUMENTS2019-04-25
FLYTE TOGA, 2XL, ZIPPER, PEELAWAYSTRYKER INSTRUMENTS-KALAMAZOO2019-04-24
FLYTE SURGICOOL TOGA, XL, PULLOVERSTRYKER INSTRUMENTS-KALAMAZOO2019-04-24
FLYTE SURGICOOL TOGA, 2XL, PULLOVERSTRYKER INSTRUMENTS-KALAMAZOO2019-04-24
T4 HOODSTRYKER INSTRUMENTS-KALAMAZOO2019-04-24
T4 PULLOVER TOGA, L/XLSTRYKER INSTRUMENTS-KALAMAZOO2019-04-24
MEDLINE - SURGICAL GOWN LEVEL 3MEDLINE INDUSTRIES2019-04-19
CONVERTORSCARDINAL HEALTH 200, LLC2019-04-09
GOWN, SURGICALCARDINAL HEALTH 200, LLC2019-03-07
CONVERTORSCARDINAL HEALTH 200, LLC2019-02-21
NOVO HEALTH SERVICESNOVO HEALTH SERVICES2019-02-21
CONVERTORSCARDINAL HEALTH 200, LLC2019-02-21
NOVO HEALTH SERVICESNOVO HEALTH SERVICES2019-01-30
NOVO HEALTH SERVICESNOVO HEALTH SERVICES2019-01-30
T4 HOODSTRYKER INSTRUMENTS-KALAMAZOO2019-01-29
T4 ZIPPER TOGA, L/XLSTRYKER INSTRUMENTS-KALAMAZOO2018-12-11
NOVO HEALTH SERVICESNOVO HEALTH SERVICES2018-11-26
FLYTE SURGICOOL TOGA, 2XL, PULLOVERSTRYKER INSTRUMENTS-KALAMAZOO2018-11-21
FLYTE SURGICOOL TOGA, 2XL, PULLOVERSTRYKER INSTRUMENTS-KALAMAZOO2018-11-21
FLYTE SURGICOOL TOGA, 2XL, PULLOVERSTRYKER INSTRUMENTS-KALAMAZOO2018-11-21
FLYTE SURGICOOL TOGA, 2XL, PULLOVERSTRYKER INSTRUMENTS-KALAMAZOO2018-11-21
FLYTE SURGICOOL TOGA, 2XL, PULLOVERSTRYKER INSTRUMENTS-KALAMAZOO2018-11-21
FLYTE SURGICOOL TOGA, 2XL, PULLOVERSTRYKER INSTRUMENTS-KALAMAZOO2018-11-21
FLYTE SURGICOOL TOGA, XL, PULLOVERSTRYKER INSTRUMENTS-KALAMAZOO2018-11-19

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