| Device Type ID | 2815 |
| Device Name | Gown, Surgical |
| Regulation Description | Surgical Apparel. |
| Regulation Medical Specialty | General & Plastic Surgery |
| Review Panel | General Hospital |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Surgical Devices (DSD) General Surgery Devices Branch One - Light Based/Laser (GSDB1) |
| Submission Type | 510(k) |
| CFR Regulation Number | 878.4040 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | FYA |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Expansion Pilot Program |
|
| Device Type ID | 2815 |
| Device | Gown, Surgical |
| Product Code | FYA |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Surgical Apparel. |
| CFR Regulation Number | 878.4040 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
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 |