POWDERFREE POLYISOPRENE SURGICAL GLOVES— 510(k) K112654
Substantially EquivalentPt. Medisafe Technologies
FDA 510(k) clearance K112654 for POWDERFREE POLYISOPRENE SURGICAL GLOVES, Substantially Equivalent on 2012-02-17. Applicant: Pt. Medisafe Technologies. Device class: 1.
Clearance details
- Applicant
- Pt. Medisafe Technologies
- 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
- Medan, North Sumatra, ID
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More clearances from Pt. Medisafe Technologies
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- K182176 — Polychloroprene Powder Free Sterile Surgical Gloves, White, Tested for Use with Chemotherapy Drugs
- K173258 — Polychloroprene Powder Free Sterile Surgical Gloves, White, Tested for Use with Chemotherapy
- K163041 — Powder Free Polychloroprene Examination Gloves-Pink with Aloe Vera and Vitamin E
- K142941 — Powder-Free Polyisoprene Sterile Surgical Gloves in White Color Tested for Use with Chemotherapy Drugs, Powder-Free Polyisoprene Sterile Surgical Gloves in Green Color.
Data sourced from openFDA. This site is unofficial and independent of the FDA.