SensiCare PI Ortho LT Surgical Glove (Tested for Use with Chemotherapy Drugs)— 510(k) K203538
Substantially EquivalentMedline Industries, Inc.
FDA 510(k) clearance K203538 for SensiCare PI Ortho LT Surgical Glove (Tested for Use with Chemotherapy Drugs), Substantially Equivalent on 2021-08-02. 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
- Northfield, IL, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.