Product code FYE
- Device name
- Dress, Surgical
- Medical specialty
- General, Plastic Surgery
- Device class
- 1
- Regulation number
- 878.4040
- Review panel
- SU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K932731 | BARRIER* EXTRA PROTECTION PLUS SURGICAL GOWN | Johnson & Johnson Medical, Inc. | 1994-04-11 |
| K912790 | SURGICAL GOWN | Unicor Federal Dept. of Justice | 1991-09-19 |
| K910920 | PROTEKT GLOVES | Intermedics Orthopedics | 1991-05-15 |
| K910941 | LIFELINER SURGICAL GLOVE | Depuy-Raynham | 1991-05-09 |
| K895667 | STERILE SURGICAL GOWN | Clinitech, Inc. | 1989-10-13 |
| K895235 | VARIOUS DISPOSABLE SURGICAL GARMENTS | Protect Corp. of Indiana, Inc. | 1989-09-19 |
| K894760 | CLOTHINGUARD | Barrier Concepts, Inc. | 1989-08-18 |
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|---|---|---|---|
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| 10810100050334 | KBMED | KB Medical (group), Inc. | 2025-05-22 |
| 10810100050327 | KBMED | KB Medical (group), Inc. | 2025-05-22 |
| 10810100050310 | KBMED | KB Medical (group), Inc. | 2025-05-22 |
| 00810100050344 | KBMED | KB Medical (group), Inc. | 2025-05-22 |
| 00810100050337 | KBMED | KB Medical (group), Inc. | 2025-05-22 |
| 00810100050320 | KBMED | KB Medical (group), Inc. | 2025-05-22 |
| 00810100050313 | KBMED | KB Medical (group), Inc. | 2025-05-22 |
| 10097604603345 | Tronex International, Inc. | TRONEX INTERNATIONAL, INC. | 2022-10-28 |
| 00097604603348 | Tronex International, Inc. | TRONEX INTERNATIONAL, INC. | 2022-10-28 |
| 00097604601122 | Tronex International, Inc. | TRONEX INTERNATIONAL, INC. | 2022-10-28 |
| 10097604601129 | Tronex International, Inc. | TRONEX INTERNATIONAL, INC. | 2022-10-28 |
| 06970645860113 | YINGJIA | Jiangsu Jiawen Medical Supplies Co.,Ltd. | 2022-10-20 |
| 50732224000935 | Disposable Face Shields | CROSSTEX INTERNATIONAL, INC. | 2022-08-19 |
| 00732224000930 | Crosstex Disposable Face Shields | CROSSTEX INTERNATIONAL, INC. | 2022-08-19 |
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| 00813360021390 | Protexer | ICP MEDICAL, LLC | 2022-02-03 |
| 10653160317609 | Centurion | CENTURION MEDICAL PRODUCTS CORPORATION | 2022-01-01 |
| 10653160217626 | Centurion Medical Products Corp | MEDLINE INDUSTRIES, INC. | 2021-09-02 |
| B086105051 | Protect U Guard CPE Isolation Gown | PROTECT U GUARD, LLC | 2021-02-02 |
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| 10603295326359 | LIFE LINER | DEPUY ORTHOPAEDICS, INC. | 2018-09-24 |