Sterile Powder Free Synthetic Rubber Surgeons Gloves, Green Color, Tested For Use With Chemotherapy Drugs and Gastric Acid— 510(k) K250313
Substantially EquivalentHarps Europe Manufacturing GmbH
FDA 510(k) clearance K250313 for Sterile Powder Free Synthetic Rubber Surgeons Gloves, Green Color, Tested For Use With Chemotherapy Drugs and Gastric Acid, Substantially Equivalent on 2025-08-19. Applicant: Harps Europe Manufacturing GmbH. Device class: 1.
Clearance details
- Applicant
- Harps Europe Manufacturing GmbH
- 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
- Abbreviated
- Location
- Niederosterreich, AT
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Data sourced from openFDA. This site is unofficial and independent of the FDA.