510(k) K022162
- Device
- STRYKER T4 URETHANE HOOD; STRYKER T4 URETHANE ZIPPER TOGA; STRYKER T4 URETHANE PULLOVER TOGA
- Applicant
- STRYKER INSTRUMENTS
- 510(k) number
- K022162
- Product code
- FYA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2002-08-01
- Date received
- 2002-07-03
- Regulation
- 878.4040
- Classification name
- Gown, Surgical
- Medical specialty
- General & Plastic Surgery
- Review panel
- General Hospital
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- DANNIELLE WHEELER
- Address
- 4100 E. Milham Ave. Kalamazoo MI US 49001 49001
FDA Registration Numbers#
- 3011545608
- 3026383899
- 3010432890
- 3026536498
- 3012344767
- 3044906632
- 3005142514
- 3012421607
- 3015633688
- 3016678045
- 3005748481
- 3030446844
- 3007007790
- 3042953920
- 3014925393
- 3016844398
- 3004133257
- 3006425876
- 3008252907
- 1423625
- 9680794
- 3011494917
- 3008191254
- 3011547453
- 3004111573
- 3009176340
- 3010796396
- 3044026004
- 3016509375
- 3006437555
- 3013466775
- 2431166
- 3031572397
- 3020163307
- 8030672
- 3005099803
- 3043226252
- 9680646
- 3008559312
- 9616088
- 3017398283
- 9680222
- 3030733800
- 3034226814
- 1058584
- 3030067857
- 9614277
- 1066741
- 3030394731
- 3008959420
- 3008328679
- 3006973666
- 3013410562
- 3045816907
- 1043214
- 3011497662
- 3019798849
- 3042245424
- 3003348807
- 3000268902
- 3016680721
- 3025771437
- 3036773433
- 3017910185
- 3004713352
- 3005997949
- 1043644
- 3032507796
- 3011500469
- 3013421458
- 1423395
- 3035642068
- 3010041511
- 3010621964
- 2032098
- 3016763307
- 3010625818
- 3004513970
- 3007088677
- 3017884933
Source Documents#
Other 510(k) Records For Product Code FYA #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| K233183 | Surgical Gown (40083) | Ammex-Weida (Hubei) Health and Safety Products Co., Ltd. | 2024-02-01 |
Legacy Summary#
summary
FDA Review#
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