510(k) K221139
- Device
- Bodygard SFS Surgical Gown Level 4
- Applicant
- Feliks Plastik Laminasyon Ve Ambalaj Malzemeleri
- 510(k) number
- K221139
- Product code
- FYA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2022-11-10
- Date received
- 2022-04-19
- Regulation
- 878.4040
- Classification name
- Gown, 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
- Ali Serdar Serteser
- Address
- Sanayi Ve Tic A. S. Eskisehir Organize Sanayi Bolgesi 26, Cadde # 9 Odunpazari TR 26110 26110
FDA Registration Numbers#
- 3006437555
- 9616088
- 3008729549
- 3009443860
- 3011497662
- 3010154727
- 3013298431
- 3008824097
- 3015633688
- 8030607
- 3027977504
- 8022129
- 8030678
- 3010432890
- 3006973666
- 3014421917
- 3010873451
- 3016680721
- 3007088677
- 3015967359
- 3013525704
- 3002807090
- 3009750712
- 1721686
- 3015960676
- 3026536498
- 3016844398
- 3005675811
- 3003561450
- 1319639
- 3030419987
- 3018058145
- 3007344957
- 3039394934
- 3008328679
- 3013429557
- 3035642068
- 3026383899
- 3018781093
- 3034629649
- 3008191254
- 3042245424
- 3016711507
- 3005841027
- 2183744
- 3043226252
- 1928237
- 3001650535
- 3006891803
- 3017300722
- 3006540014
- 3011547453
- 3034204758
- 3010014065
- 3012497308
- 3014146451
- 3010796396
- 3015058854
- 3038718579
- 3005997949
- 3009176340
- 3013496867
- 3014479313
- 3016763307
- 3021274073
- 3017467279
- 3015895045
- 9616876
- 9616096
- 3010419931
- 3013960812
- 2320762
- 3014926389
- 3004362278
- 1836161
- 3011545608
- 3017910185
- 3002806603
- 8043817
- 3019798849
Source Documents#
Other 510(k) Records For Product Code FYA #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260407 | Principle & Will ANSI/AAMI PB 70 (Sterile/Non-sterile) Level 3 Surgical Gowns (Reinforced) and Principle & Will ANSI/AMMI PB70 (Sterile/Non-sterile) Level 4 Surgical Gowns/Isolation Gowns | Principle & Will Co., Ltd. | 2026-08-26 |
| K261028 | Surgical Gown Level2 (S, M, L, XL, XXL, XXXL) | Yadu Medical (Henan) Co., Ltd. | 2026-08-07 |
| K261949 | NYES Tuff Cuff L3 Disposable Gowns | New York Embroidery Studio | 2026-07-10 |
| K252575 | Tuff Cuff™ Disposable Surgical Gowns AAMI L4 Sterile-Large (ML-L4-STL-DC-L) | New York Embroidery Studio (NYES) | 2026-06-04 |
| K260725 | BAÜMER Surgical Gowns (COP01, COP04, COP05, COP10) | Hindernis DE Mexico, S.A.P.I. DE C.V. | 2026-05-12 |
| K253243 | Cardinal Health™ Poly Reinforced Surgical Gown | Cardinal Health 200, LLC | 2026-04-28 |
| K253003 | Non-sterile Level 3 Surgical Gown (4025); Sterile Level 3 Surgical Gown (M4025); Non-sterile Reinforced Level 4 Surgical Gown (G4025); Reinforced Sterile Level 4 Surgical Gown (GM4025) | Hubei Xinxin Non-Woven Co., Ltd. | 2026-04-20 |
| K251860 | Copioumed AAMI 3 Surgical Gown | Copioumed International, Inc. | 2026-02-26 |
| K252301 | Henan Yadu Level 4 Surgical Gowns (Reinforced) | Yadu Medical (Henan) Co., Ltd. | 2026-02-04 |
| K250564 | Surgical Gown (Level 3: S, M, L, XL, XXL, XXXL) | Yadu Medical (Henan) Co., Ltd. | 2025-12-03 |
| K243522 | ViVi® Toga Premium | Thi Total Healthcare Innovation GmbH | 2025-05-30 |
| K242937 | Dream Medi Sterile Surgical Gown (SurgicalGownUL) | Dae Myung Chemical Co., Ltd. (Vietnam) | 2025-05-05 |
| K242844 | Medline Level 4 Surgical Gown with Breathable Sleeves | Medline Industries, LP | 2025-02-26 |
| K241272 | Stryker Steri-Shield 8 Surgical Hoods and Togas | Stryker Instruments | 2024-10-16 |
| K241214 | ProPel SG3™ Surgical Gown | Standard Textile Co., Inc. | 2024-09-10 |
Legacy Summary#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases