Sterile Powder Free Synthetic Rubber Surgeon’s Gloves, Green Color, Tested For Use With Chemotherapy Drugs and Gastric Acid
FDA 510(k) clearance K250313 · decided 2025-08-19
Clearance details
- K-number
- K250313
- Device name
- Sterile Powder Free Synthetic Rubber Surgeon’s Gloves, Green Color, Tested For Use With Chemotherapy Drugs and Gastric Acid
- Applicant
- Harps Europe Manufacturing GmbH
- Decision
- Substantially Equivalent
- Date received
- 2025-02-03
- Decision date
- 2025-08-19
- Days to decision
- 197 days
- Clearance type
- Abbreviated
- Product code
- KGO
- Device class
- 1
- Regulation number
- 878.4460
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Niederosterreich, AT
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.