510(k) K820363
- Device
- DISPOSABLE SURGICAL GARMENTS
- Applicant
- ALPHAMEDIX, INC.
- 510(k) number
- K820363
- Product code
- FYA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1982-03-08
- Date received
- 1982-02-09
- 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#
- 3010625818
- 3004513970
- 3013443304
- 3016711507
- 3008837339
- 3006723155
- 1651395
- 3042953920
- 3011547453
- 9680646
- 3014146451
- 3031982537
- 1423625
- 3008191254
- 3010305275
- 3014479313
- 3034669683
- 3016761372
- 1928237
- 1123137
- 3001124136
- 3032507796
- 9680357
- 9680222
- 3005748481
- 1066741
- 3000268902
- 3016844398
- 3008352384
- 3005595283
- 3038718579
- 9616096
- 3010432890
- 2030624
- 3034204758
- 3015859709
- 3006540014
- 3012497308
- 1055892
- 3013735189
- 3044906632
- 3005391805
- 3042245424
- 3038356900
- 3011497662
- 1423537
- 3013548473
- 3014421917
- 3013410562
- 3003495693
- 1043214
- 3013421458
- 3013525704
- 3012811961
- 1030451
- 3015960676
- 3010807315
- 3025771437
- 3034226814
- 3004133257
- 3008489813
- 3014315560
- 3013429557
- 3009750712
- 3023228837
- 8030607
- 3008824097
- 3026536498
- 3008328679
- 3013496867
- 1643817
- 3016678045
- 3016096096
- 3017398283
- 3004911384
- 3010419931
- 3016452400
- 3030067857
- 1055236
- 1818910
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#
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