510(k) K043017
- Device
- PREVENTION BREATHABLE, IMPERVIOUS SURGICAL GOWNS
- Applicant
- MEDLINE INDUSTRIES, INC.
- 510(k) number
- K043017
- Product code
- FYA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2005-03-08
- Date received
- 2004-11-02
- 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
- LARA N SIMMONS
- Address
- 1170 S. Northpoint Blvd. Waukegan IL US 60085 60085
FDA Registration Numbers#
- 3016096096
- 3016680721
- 3016680688
- 3030733800
- 1211998
- 1065597
- 3015068387
- 1066741
- 3013429557
- 3010041511
- 3031572397
- 3030446844
- 9680887
- 3004362278
- 3015173212
- 3014159736
- 3026383899
- 1526350
- 3021274073
- 3010305275
- 2030624
- 3006973666
- 9681151
- 3004713352
- 3011547453
- 3014315560
- 3015468759
- 8030607
- 3014314985
- 3020163307
- 3011089435
- 9614277
- 3005099803
- 9614306
- 3012811961
- 3044906632
- 3013421458
- 3034669683
- 3017636737
- 3013557562
- 3014666579
- 1643817
- 3043226252
- 1527185
- 3045816907
- 3002807090
- 3013525704
- 3019798849
- 3008489813
- 3006437555
- 3004122598
- 3014925389
- 3038718579
- 3010131137
- 1054241
- 1030451
- 9680794
- 3012268821
- 3044026004
- 3017398283
- 3013410562
- 3008191254
- 1921846
- 8043817
- 3030394731
- 1527607
- 3008502431
- 3013659050
- 3001124136
- 3003495693
- 3008959420
- 1818910
- 3006540014
- 3014925393
- 3031982537
- 3015140351
- 2648727
- 3015058854
- 1047429
- 1055236
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