510(k) K210414
- Device
- CoverU Disposable Gown With Tape AAMI Level 4 Isolation Gown, Model Number: IL-4036YKTP-L4, CoverU Disposable Gown With Tape AAMI Level 4 Isolation Gown, Model Number: IL-4063WKTP-L4, CoverU Disposable Gown With Tape Chemo Gown, Model Number: IL-4036
- Applicant
- Medtecs (Taiwan) Corp.
- 510(k) number
- K210414
- Product code
- FYC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2022-10-21
- Date received
- 2021-02-11
- Regulation
- 878.4040
- Classification name
- Gown, Isolation, Surgical
- Medical specialty
- General & Plastic Surgery
- Review panel
- General Hospital
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- William Yang
- Address
- 11f., # 9, Songgao Rd., Xinyi Dist. Taipei City TW 11073 11073
FDA Registration Numbers#
- 3013502418
- 1018470
- 9614306
- 3014925393
- 1423537
- 3016705853
- 3016763307
- 3016678045
- 3015960676
- 3017171460
- 3011545608
- 9611959
- 9681151
- 3016844398
- 2648727
- 1043214
- 3017896419
- 2320762
- 3011547453
- 3013960812
- 3012344767
- 1921846
- 3006400329
- 3004513970
- 9616096
- 3021274073
- 3017597597
- 1055236
- 3017180923
- 3006723155
- 9615270
- 1417592
- 9680646
- 3004111573
- 3010155681
- 3013260641
- 3003561450
- 3014421917
- 3003495693
- 3007838093
- 1933975
- 3009750712
- 3009540572
- 3016680688
- 3017494520
- 2433012
- 3020755815
- 9680222
- 1423205
- 3017467279
- 3016096096
- 1054241
- 3006538071
- 3015820879
- 3015140351
- 3026536498
- 3004158259
- 3008959420
Source Documents#
Other 510(k) Records For Product Code FYC #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K232849 | Halyard Tri-Layer AAMI 3 Isolation Gown, L, Blue (54310), Halyard Tri-Layer AAMI 3 Isolation Gown, X-Large, Blue (54311) | Owens & Minor (O&M) Halyard, Inc. | 2024-05-16 |
| K230135 | Copioumed Chemotherapy Isolation Gown | Copioumed International, Inc. | 2023-10-04 |
| K223467 | Disposable Isolation Gown | Nanning Tecbod Biological Technology Co., Ltd. | 2023-02-10 |
| K223304 | Disposable Isolation Gowns (S,M,L,XL,XXL,XXXL) | Xiamen Probtain Medical Technology Co., Ltd. | 2023-02-08 |
| K223411 | Disposable Isolation Gowns (S,M,L,XL,XXL,XXXL) | Xiamen Probtain Medical Techology Co., Ltd. | 2023-01-04 |
| K212717 | Paneffort AAMI Level 3 Isolation Gown | Paneffort, LLC | 2022-11-30 |
| K214116 | AAMI4 Isolation Gown | Hubei Xinxin Non-Woven Co., Ltd. | 2022-10-11 |
| K221027 | Isolation Gown (S, M, L, XL, XXL (Yellow, Blue)) | Allmed Medical (Hubei) Protective Products Co., Ltd. | 2022-08-12 |
| K220528 | Surgical Isolation Cover Gown | Wuhan Dymex Healthcare Co., Ltd. | 2022-06-10 |
| K213832 | AAMI3 Isolation Gown | Hubei Xinxin Non-Woven Co., Ltd. | 2022-05-16 |
| K212422 | Disposable Surgical Isolation Gown | Crown Name Disposable Hygiene Products Fty., Ltd. | 2022-04-29 |
| K210148 | Flosteril Poly-reinforced Isolation Gowns Model 8120 (Catalogue Number 8120400), Flosteril Poly-reinforced Isolation Gowns Model (Catalogue Number 8120410), Flosteril Poly-reinforced Isolation Gowns Model (Catalogue Number 8120430), Flosteril Poly-reinforced Isolation Gowns Model (Catalogue Number 8120450), Flosteril Poly-reinforced Isolation Gowns Model (Catalogue Number 8120460) | Flomak Tekstil Makine Muh. Mum. Taah. San. Tic. Ltd. Sti. | 2022-04-13 |
| K212698 | Plus Medical Isolation Gown Level 3 | Foshan Nanhai Plus Medical Co, Ltd. | 2022-03-02 |
| K212357 | Surgical isolation gown | Wuhan Zonsen Medical Products Co., Ltd. | 2022-01-20 |
| K212633 | Disposable Isolation Gown -Level 3, Large, Blue, Disposable Isolation Gown - Level 3, X-Large, Blue | String King Lacrosse, LLC | 2021-11-24 |
Legacy Summary#
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FDA Review#
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