510(k) K042111
- Device
- PROMEDICAL SURGICAL GOWNS
- Applicant
- PROMEDICAL PRODUCTS CO., LTD.
- 510(k) number
- K042111
- Product code
- FYA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2004-12-10
- Date received
- 2004-08-05
- 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
- BOYD HARRIS
- Address
- 125 Clements Ave. Starkville MS US 39759 39759
FDA Registration Numbers#
- 3030067857
- 3016711507
- 3007344957
- 3005099803
- 3008824097
- 3031572397
- 3010621964
- 3006538822
- 3006113262
- 3029897710
- 3015895045
- 3034669683
- 1836161
- 9680887
- 3004513970
- 3038356900
- 3011547453
- 3015633688
- 3042245424
- 3014213264
- 3005142514
- 3012595397
- 3044906632
- 3017171460
- 1211998
- 3006437555
- 3015960676
- 3038718579
- 3008729549
- 3017398283
- 3030733800
- 3016680688
- 3036773433
- 1721686
- 1043644
- 3031982537
- 3033536319
- 3006400329
- 3010419931
- 3027977504
- 1527185
- 1123137
- 3016452400
- 3008770063
- 3001124136
- 9614277
- 3014159736
- 3014421917
- 3030394731
- 3016509375
- 3011089435
- 3003348807
- 3010625818
- 3035642068
- 3013600605
- 3009176340
- 3010014065
- 3003561450
- 3016844398
- 3006847952
- 3006891803
- 3044026004
- 3007289408
- 2032098
- 3011497662
- 3013298431
- 3005246893
- 3008252907
- 3008328679
- 3016761372
- 1054241
- 1065597
- 3010807315
- 1651395
- 3015068387
- 3009443860
- 3003495693
- 9681151
- 3018058145
- 3017636737
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code FYA #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| K233571 | GCI Surgical Gown | George Courey, Inc. | 2024-08-02 |
| K233068 | Disposable Surgical Gown | Nanning Tecbod Biological Technology Co., Ltd. | 2024-03-29 |
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