Dermasure Green Sterile SyntheticPolychloroprene Powder-Free Surgical Glove Tested for Use— 510(k) K192988
Substantially EquivalentMedline Industries, Inc.
FDA 510(k) clearance K192988 for Dermasure Green Sterile SyntheticPolychloroprene Powder-Free Surgical Glove Tested for Use, Substantially Equivalent on 2020-04-01. 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.