MCARE PF POWDER FREE LATEX EXAMINATION HIGH RISK GLOVES— 510(k) K141042
Substantially EquivalentMercator Medical (Thailand), Ltd.
FDA 510(k) clearance K141042 for MCARE PF POWDER FREE LATEX EXAMINATION HIGH RISK GLOVES, Substantially Equivalent on 2015-03-19. Applicant: Mercator Medical (Thailand), Ltd.. Device class: 1.
Clearance details
- Applicant
- Mercator Medical (Thailand), Ltd.
- Product code
- Code LYY
- Device class
- Class 1
- Regulation
- 21 CFR 880.6250
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Littleton, CO, US
Recent devices under product code LYY
view all- K250069 — Powder Free Natural Rubber Latex Examination Gloves Blue, Non-Sterile and Protein Claim Of 50 Micrograms per dm2 Or Less Protein
- K240266 — Latex Examination Glove Powder Free (Ocean Blue and Natural White)
- K230573 — Powder Free Latex Patient Examination Glove, Black Colored, Non-sterile, with Protein Content labeling Claim (Contains 50 ug per dm2 of glove or less of Total Water Extractable Protein)
- K223298 — Sterile Latex Examination Gloves Powder Free (S, M, L, Extra L)
- K222612 — Powder-Free Latex examination gloves
More clearances from Mercator Medical (Thailand), Ltd.
view all- K251141 — Powder Free Nitrile Patient Examination Glove, Blue colored, Non-sterile Tested for Use with Chemotherapy Drugs and Fentanyl Citrate +1 more
- K213548 — Nitrylex Classic Powder Free Nitrile Blue Examination Gloves Tested for Use with Chemotherapy
- K200967 — mCare(R) Powder Free Nitrile Orange Examination Gloves
- K192444 — mCare® Powder Free Nitrile Black Examination Glove
- K190876 — mCare®Powder-free Nitrile Blue Examination Gloves with Chemotherapy Drugs Labeling Claimed
Data sourced from openFDA. This site is unofficial and independent of the FDA.