510(k) K222480
- Device
- Standard Surgical Gown (AAMI Level 2); Reinforced Surgical Gown (AAMI Level 2)
- Applicant
- Foshan Nanhai Plus Medical Co, Ltd.
- 510(k) number
- K222480
- Product code
- FYA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2022-11-14
- Date received
- 2022-08-17
- Regulation
- 878.4040
- Classification name
- Gown, Surgical
- Medical specialty
- General, Plastic Surgery
- Review panel
- General, Plastic Surgery
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- N
Related Records
Applicant Contact
- Contact
- Eric Li
- Address
- Shatou Jiujiang Town Nanhai District Foshan CN 5282000 5282000
FDA Registration Numbers
- 3036773433
- 3030088999
- 3002807090
- 3014925393
- 3017398283
- 3038356900
- 3008770063
- 3015895045
- 3004362278
- 3031572397
- 3018058145
- 1043644
- 3016452400
- 1061124
- 3033848619
- 3006847952
- 9681151
- 3007082897
- 3005748481
- 3016680688
- 3013580507
- 3012811961
- 2183744
- 3017300722
- 3034226814
- 9614277
- 3016711507
- 2032098
- 3020163307
- 3007007790
- 1018470
- 1030451
- 3015140351
- 1066741
- 3013502418
- 9680646
- 3027977504
- 3008352384
- 3004133257
- 3012497308
- 3005012805
- 3013429557
- 3030394731
- 2648727
- 3017467279
- 3001124136
- 3013557562
- 8022129
- 3014314985
- 3010131137
- 9614306
- 1423537
- 3003495693
- 3012595397
- 3015633688
- 3010154727
- 3010305275
- 3006425876
- 3021274073
- 3011545608
- 3032507796
- 8030678
- 3003561450
- 3005099803
- 3008959420
- 3007344957
- 3013298431
- 1423625
- 3017636737
- 1651395
- 1423395
- 3011089435
- 3009176340
- 9616876
- 3030733800
- 3006538822
- 3010014065
- 3010625818
- 3014926389
Source Documents
510(k) summary PDF not indicated by FDA
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|---|---|---|---|
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