SensiCare PI and SensiCare PI Micro Surgical Gloves— 510(k) K193217
Substantially EquivalentMedline Industries, Inc.
FDA 510(k) clearance K193217 for SensiCare PI and SensiCare PI Micro Surgical Gloves, Substantially Equivalent on 2020-04-06. Applicant: Medline Industries, Inc.. Device class: 1.
Clearance details
- Applicant
- Medline Industries, Inc.
- Product code
- Code KGO
- Device class
- Class 1
- Regulation
- 21 CFR 878.4460
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Northfiled, IL, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.