Panels › General, Plastic Surgery › Product code OEA · Class 1
Non-Surgical Gown
Regulation 878.4040
0510(k)s in 12 months (0 all time)
1recalls in 12 months (18 all time)
0recalls that name a 510(k)
Top companies in OEA
| Company | 510(k)s | Recalls |
|---|---|---|
| Cardinal Health 200, LLC | 0 | 13 |
| Cardinal Health | 0 | 1 |
| New York Embroidery Studio, Inc. | 0 | 1 |
| ROi CPS LLC | 0 | 1 |
| Sobel Westex | 0 | 1 |
| Stryker Corporation | 0 | 1 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 23, 2026 | New York Embroidery Studio, Inc. New York Embroidery Studio Trinity Non-Surgical Isolation Gown, AAMI PB70 Level 2, X-Large. Model Number: NYES100-2.
Packaged in inner packs of 10 and 100 gowns per shipping case. Open, Classified |
OEA | None listed |
| Jul 3, 2024 | Stryker Corporation The Non-Sterile Flyte hood covers the user s head and neck region and is intended to be worn with commercially available gowns. The hood is donned after the Flyte helmet and before the gown, such that Open, Classified |
OEA | None listed |
| Jan 7, 2021 | Cardinal Health 200, LLC Gown Kendall Blue XXL, SKU CT5102
Cardinal Health Isolation Gown, Lab Coat, and Kendall" Gowns are intended to provide minimal barrier protection to protect health care patients and health care perso Open, Classified |
OEA | None listed |
| Jan 7, 2021 | Cardinal Health 200, LLC Gown Kendall Blue L, SKU CT5100, CT5101
Cardinal Health Isolation Gown, Lab Coat, and Kendall" Gowns are intended to provide minimal barrier protection to protect health care patients and health care Open, Classified |
OEA | None listed |
| Jan 7, 2021 | Cardinal Health 200, LLC Gown Kendall Blue RG, SKU CT5000
Cardinal Health Isolation Gown, Lab Coat, and Kendall" Gowns are intended to provide minimal barrier protection to protect health care patients and health care person Open, Classified |
OEA | None listed |
| Jan 7, 2021 | Cardinal Health 200, LLC Lab Coats SMS 2X-Large White, SKU 2304LC
Cardinal Health Isolation Gown, Lab Coat, and Kendall" Gowns are intended to provide minimal barrier protection to protect health care patients and health car Open, Classified |
OEA | None listed |
| Jan 7, 2021 | Cardinal Health 200, LLC Lab Coats SMS Large White, SKU 2302LC
Cardinal Health Isolation Gown, Lab Coat, and Kendall" Gowns are intended to provide minimal barrier protection to protect health care patients and health care p Open, Classified |
OEA | None listed |
| Jan 7, 2021 | Cardinal Health 200, LLC Lab Coats SMS Medium White, SKU 2301LC
Cardinal Health Isolation Gown, Lab Coat, and Kendall" Gowns are intended to provide minimal barrier protection to protect health care patients and health care Open, Classified |
OEA | None listed |
| Jan 7, 2021 | Cardinal Health 200, LLC Lab Coats SMS 2X-Large Blue, SKU 2204LC
Cardinal Health Isolation Gown, Lab Coat, and Kendall" Gowns are intended to provide minimal barrier protection to protect health care patients and health care Open, Classified |
OEA | None listed |
| Jan 7, 2021 | Cardinal Health 200, LLC Lab Coats SMS X-Large Blue, SKU 2203LC
Cardinal Health Isolation Gown, Lab Coat, and Kendall" Gowns are intended to provide minimal barrier protection to protect health care patients and health care Open, Classified |
OEA | None listed |
| Jan 7, 2021 | Cardinal Health 200, LLC Lab Coats SMS Large Blue, SKU 2202LC
Cardinal Health Isolation Gown, Lab Coat, and Kendall" Gowns are intended to provide minimal barrier protection to protect health care patients and health care pe Open, Classified |
OEA | None listed |
| Jan 7, 2021 | Cardinal Health 200, LLC Gown Isolation W/Ties Xl Blue, SKU 2201PG
Cardinal Health Isolation Gown, Lab Coat, and Kendall" Gowns are intended to provide minimal barrier protection to protect health care patients and health ca Open, Classified |
OEA | None listed |
| Jan 7, 2021 | Cardinal Health 200, LLC Gown Isolation W/Ties Univ Blu, SKU 1200PG, 2200PG, 552200PG
Cardinal Health Isolation Gown, Lab Coat, and Kendall" Gowns are intended to provide minimal barrier protection to protect health care pat Open, Classified |
OEA | None listed |
| Jan 7, 2021 | Cardinal Health 200, LLC Gown Isolation W/Ties Xl Ylw, SKU 1101PG
Cardinal Health Isolation Gown, Lab Coat, and Kendall" Gowns are intended to provide minimal barrier protection to protect health care patients and health car Open, Classified |
OEA | None listed |
| Jan 7, 2021 | Cardinal Health 200, LLC Gown Isolation W/Ties Univ Ylw, SKU 1100PG, V1100PG, 2100PG, V2100PG, 2150PG, V2100PG
Cardinal Health Isolation Gown, Lab Coat, and Kendall" Gowns are intended to provide minimal barrier protection t Open, Classified |
OEA | None listed |
| Aug 13, 2020 | Sobel Westex SOBEL WESTEX Disposable Isolation Gown Made in China RN#71273 SBPP non woven laminate with PE Film - Product Usage: use in patient/healthcare personnel interactions. AAMI Level II isolation gowns are Terminated |
OEA | None listed |
| May 19, 2020 | ROi CPS LLC Isolation Droplet Bundle Kit Terminated |
OEA | None listed |
| Jul 20, 2016 | Cardinal Health BLUE IMPERVIOUS GOWN WITH THUMBHOOKS, X-LARGE. Non-Sterile, Single Use Only, Plastic Non-Surgical Isolation Gown Non-Sterile, Single Use Only, Plastic Non-Surgical Isolation Gown. Serves as physical b Terminated |
OEA | None listed |
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