510(k) K781682
- Device
- SURGICAL GOWNS & DRAPES
- Applicant
- KIMBERLY-CLARK CORP.
- 510(k) number
- K781682
- Product code
- FYA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1978-12-20
- Date received
- 1978-10-02
- Regulation
- 878.4040
- Classification name
- Gown, Surgical
- Medical specialty
- General & Plastic Surgery
- Review panel
- General Hospital
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 3026383899
- 3013429557
- 3014666579
- 3004122598
- 3005099803
- 3003561450
- 3013421458
- 3008352384
- 3003348807
- 3010873451
- 3015468759
- 3015633688
- 3005748481
- 3005675811
- 3013298431
- 3010625818
- 3013735189
- 3015960676
- 3006891803
- 3016705853
- 3009176340
- 3044026004
- 3013659050
- 9616088
- 3011545608
- 3012268821
- 2431166
- 3013580507
- 3021274073
- 3014314985
- 3016452400
- 1319639
- 3006437555
- 3004911384
- 1818910
- 3032507796
- 2648727
- 3006538822
- 3015895045
- 3030419987
- 2029015
- 3013525704
- 1423395
- 3018058145
- 3031982537
- 9614306
- 1043214
- 1018470
- 1066741
- 3007082897
- 1047429
- 3010014065
- 3008559312
- 3045816907
- 3016680721
- 3044906632
- 3034669683
- 3010807315
- 3016509375
- 9616096
- 3013466775
- 1423537
- 1423625
- 3001124136
- 3016680688
- 2032098
- 3007007790
- 9616876
- 3009443860
- 3011554160
- 3010796396
- 3030088999
- 3017884933
- 1721686
- 3016761372
- 1054241
- 3017300722
- 1643817
- 3007344957
- 3007088677
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