Panels › General, Plastic Surgery › Product code FYC · Class 2
Gown, Isolation, Surgical
Regulation 878.4040
0510(k)s in 12 months (68 all time)
0recalls in 12 months (2 all time)
2recalls that name a 510(k)
Top companies in FYC
| Company | 510(k)s | Recalls |
|---|---|---|
| American Threshold Industries, Inc. | 4 | 0 |
| American Hospital Supply Corp. | 3 | 0 |
| Amsco Sterile Recoveries, Inc. | 2 | 0 |
| Cardinal Health 200, LLC | 0 | 2 |
| Dynatech Medical Products | 2 | 0 |
| Hubei Xinxin Non-Woven Co., Ltd. | 2 | 0 |
| Kentron Health Care, Inc. | 2 | 0 |
| Medtek Development Corp. | 2 | 0 |
| A Plus International, Inc. | 1 | 0 |
| Abco Dealers, Inc. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 11, 2024 | Cardinal Health 200, LLC Cardinal Health SMS Elastic Cuff Thumbhook Level 3 Isolation Gown, Full-Back, Product Codes AT6588-2XL, AT6588-BD, AT6588-XL, AT6688-2XL, AT6688-BD, and AT6688-XL Open, Classified |
FYC | K160339 |
| Dec 11, 2024 | Cardinal Health 200, LLC Convertor Isolation Gown, AAMI Level 3 protection, Product Codes AT6100, AT6100-XL, AT6200, and AT6200-XL Open, Classified |
FYC | K160339 |
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