Gown, Surgical

Device Code: 2815

Product Code(s): FYA

Device Classification Information

Device Type ID2815
Device NameGown, Surgical
Regulation DescriptionSurgical Apparel.
Regulation Medical SpecialtyGeneral & Plastic Surgery
Review PanelGeneral Hospital
Premarket Review Office Of Device Evaluation (ODE)
Division Of Surgical Devices (DSD)
General Surgery Devices Branch One - Light Based/Laser (GSDB1)
Submission Type510(k)
CFR Regulation Number878.4040 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeFYA
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Eligible For Accredited Persons Expansion Pilot Program

Recognized Standards

Total Product Life Cycle

Device Type ID2815
DeviceGown, Surgical
Product CodeFYA
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionSurgical Apparel.
CFR Regulation Number878.4040 [🔎]
Premarket Reviews
ManufacturerDecision
CARDINAL HEALTH
 
SUBSTANTIALLY EQUIVALENT
1
CARDINAL HEALTH 200, LLC
 
SUBSTANTIALLY EQUIVALENT
2
COBES INDUSTRIES CO., LTD.
 
SUBSTANTIALLY EQUIVALENT
1
FOSHAN NANHAI PLUS MEDICAL CO., LTD.
 
SUBSTANTIALLY EQUIVALENT
1
GMAX INDUSTRIES, INC.
 
SUBSTANTIALLY EQUIVALENT
1
HALYARD HEALTH, INC.
 
SUBSTANTIALLY EQUIVALENT
2
KIMBERLY-CLARK CORP.
 
SUBSTANTIALLY EQUIVALENT
1
KIMBERLY-CLARK CORPORATION
 
SUBSTANTIALLY EQUIVALENT
1
MEDLINE
 
SUBSTANTIALLY EQUIVALENT
2
MEDLINE INDUSTRIES, INC.
 
SUBSTANTIALLY EQUIVALENT
2
STRYKER CORP.
 
SUBSTANTIALLY EQUIVALENT
2
STRYKER CORPORATION
 
SUBSTANTIALLY EQUIVALENT
2
XIANTAO RAYXIN MEDICAL PRODUCTS CO., LTD.
 
SUBSTANTIALLY EQUIVALENT
1
XUCHANG ZHENGDE ENVIRONSTAR MEDICAL PRODUCTS CO.,L
 
SUBSTANTIALLY EQUIVALENT
1
ZIMMER, INC.
 
SUBSTANTIALLY EQUIVALENT
1
Device Problems
Device Contamination With Chemical Or Other Material
54
Material Integrity Problem
48
Torn Material
43
Material Split, Cut Or Torn
33
Material Separation
26
Fluid Leak
8
Delivered As Unsterile Product
8
Hole In Material
7
No Apparent Adverse Event
6
Delamination
3
Device Contamination With Body Fluid
3
Appropriate Term/Code Not Available
2
Device Emits Odor
2
Device Packaging Compromised
2
Material Fragmentation
2
Protective Measures Problem
1
Failure To Power Up
1
Image Display Error / Artifact
1
Packaging Problem
1
Break
1
Device Expiration Issue
1
Material Distortion
1
Smoking
1
Use Of Device Problem
1
Residue After Decontamination
1
Adverse Event Without Identified Device Or Use Problem
1
Improper Or Incorrect Procedure Or Method
1
Device Reprocessing Problem
1
Total Device Problems 260
Recalls
Manufacturer Recall Class Date Posted
1
American Contract Systems, Inc.
II Feb-27-2019
2
Customed, Inc
II Apr-14-2016
3
Customed, Inc
II Sep-03-2015
4
Customed, Inc
I Dec-16-2014
5
EXP Pharmaceutical Services Corp
II Jul-24-2015
6
Master & Frank (Pinghu) Co., Ltd.
II Aug-28-2017
7
Microtek Medical Inc
II Mar-27-2015
8
Stryker Instruments Div. Of Stryker Corporation
II Apr-24-2018
9
Stryker Instruments Div. Of Stryker Corporation
III Feb-10-2015
TPLC Last Update: 2019-04-02 20:19:13

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