Polychloroprene Powder Free Sterile Surgical Gloves, Low Dermatitis Potential and Tested for Use with Chemotherapy Drugs— 510(k) K201774
Substantially EquivalentPt. Medisafe Technologies
FDA 510(k) clearance K201774 for Polychloroprene Powder Free Sterile Surgical Gloves, Low Dermatitis Potential and Tested for Use with Chemotherapy Drugs, Substantially Equivalent on 2020-09-16. 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
- Tanjung Morawa, Medan, ID
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More clearances from Pt. Medisafe Technologies
view all- 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.
- K142190 — Polychloroprene Powder-free Surgical Glove (White) Tested for Use with Chemotherapy Drugs +1 more
Data sourced from openFDA. This site is unofficial and independent of the FDA.