510(k) K242844
- Device
- Medline Level 4 Surgical Gown with Breathable Sleeves
- Applicant
- Medline Industries, LP
- 510(k) number
- K242844
- Product code
- FYA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-02-26
- Date received
- 2024-09-20
- 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
- Summary
- Third party reviewed
- N
- Source
- FDA openFDA 510(k) dataset plus migrated FDA.report data
Related Records
Applicant Contact
- Contact
- Kelsey Closen
- Address
- Three Lakes Dr. Northfiled IL US 60093 60093
FDA Registration Numbers
- 3036773433
- 3030088999
- 3002807090
- 3014925393
- 3017398283
- 3038356900
- 3008770063
- 3015895045
- 3004362278
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- 3005142514
- 3014421917
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- 3026536498
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- 3034204758
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- 3023228837
Source Documents
FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON
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| K230707 | Skypro, Surgical Gown 6021 | Skypro Medical Supplies Company | 2023-10-12 |
| K230610 | Disposable Surgical Gown (Level 3, MF2103 Series), Disposable Surgical Gown (Level 3, MF2104 Series), Disposable Surgical Gown (Level 4, MF2105 Series) | Dongguan Shin YI Healthcare Products Factory | 2023-08-23 |