510(k) K101593
- Device
- EMM SURGICAL GOWN-SMS WITH PE LAYER, MODEL 18-501 L, 18-501-XL, 18-501 XXL, 18-501-XLXL
- Applicant
- EXACT MEDICAL MANUFACTURING, INC
- 510(k) number
- K101593
- Product code
- FYA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2010-09-03
- Date received
- 2010-06-08
- 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
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- ROBERT O DEAN
- Address
- 1083 Delaware Ave. Buffalo NY US 14209 14209
FDA Registration Numbers#
- 3014315560
- 3014314985
- 3019798849
- 3013557562
- 3013429557
- 3015859709
- 3016678045
- 3016680721
- 3038356900
- 3006437555
- 3009443860
- 1526350
- 3012344767
- 3008252907
- 1055892
- 3014479313
- 3016844398
- 3015960676
- 3004361903
- 3015173212
- 1643817
- 3008559312
- 3004713352
- 1066741
- 3015468759
- 9614306
- 3008729549
- 1417592
- 3003348807
- 3026383899
- 1055236
- 1527607
- 3018781093
- 1423537
- 3009176340
- 3004513970
- 1043644
- 3010305275
- 3004911384
- 3042245424
- 3005099803
- 3015967359
- 9680357
- 3010419931
- 3007007790
- 3014325891
- 2032098
- 9680222
- 3003495693
- 3010621964
- 3035642068
- 3009750712
- 3006723155
- 3007082897
- 3012595397
- 3008770063
- 8043817
- 8022129
- 3007344957
- 1527185
- 3002806603
- 9680646
- 2183744
- 3004362278
- 3030419987
- 3033536319
- 3011545608
- 3017467279
- 3008959420
- 1211998
- 3007088677
- 3016705853
- 3013600605
- 3016763307
- 1818910
- 3038718579
- 3005142514
- 1061124
- 3004111573
- 1836161
Source Documents#
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#
summary
FDA Review#
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