510(k) K202447
- Device
- Medline Orbis Surgical Gown
- Applicant
- Medline Industries, Inc.
- 510(k) number
- K202447
- Product code
- FYA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2021-04-02
- Date received
- 2020-08-26
- 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
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- Adam Ostrower
- Address
- Three Lakes Dr. Northfiled IL US 60093 60093
FDA Registration Numbers#
- 3030088999
- 3006437555
- 3030446844
- 3000268902
- 9616088
- 3006538822
- 3013298431
- 1527185
- 3004122598
- 3008502431
- 3014479313
- 3005997949
- 3015058854
- 8030672
- 3006113262
- 3008837339
- 3018781093
- 3014421917
- 3003561450
- 3002806603
- 2029015
- 3016763307
- 3014925393
- 3034226814
- 3005748481
- 3030067857
- 3008328679
- 3025771437
- 3004361903
- 1061124
- 1055236
- 3004362278
- 3006425876
- 3016680688
- 3026383899
- 3020163307
- 3019798849
- 3008352384
- 3016761372
- 3026536498
- 3044906632
- 3013421458
- 3005675811
- 3006400329
- 3004111573
- 3009750712
- 3013466775
- 3034629649
- 3043226252
- 3044026004
- 8022129
- 1066741
- 3031572397
- 9616876
- 3001124136
- 8030678
- 3015960676
- 3012497308
- 9681151
- 9680794
- 3034669683
- 3021274073
- 3008252907
- 3013659050
- 1527607
- 3013443304
- 3032507796
- 1921846
- 3023228837
- 3014146451
- 3010131137
- 1065597
- 3016678045
- 3011545608
- 1417592
- 3016680721
- 1423625
- 3027977504
- 3012421607
- 1018470
Source Documents#
510(k) summary PDF not indicated by FDA
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