GLOVCO EBONY— 510(k) K013828
Substantially EquivalentGlovco (M) Sdn. Bhd.
FDA 510(k) clearance K013828 for GLOVCO EBONY, Substantially Equivalent on 2002-08-13. Applicant: Glovco (M) Sdn. Bhd.. Device class: 1.
Clearance details
- Applicant
- Glovco (M) Sdn. Bhd.
- 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
- Klang, Selangor D.E., MY
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 Glovco (M) Sdn. Bhd.
view all- K051345 — COLORED POWDER FREE AND POLYMER COATED PATIENT EXAMINATION GLOVE (PINK, BLUE, GREEN AND VIOLET)
- K042898 — PANTHERA N POWDER FREE BLACK NITRILE GLOVES
- K021730 — GLOVCO BRAND POWDER-FREE NITRILE EXAMINATION GLOVES (PURPLE)
- K021308 — GLOVCO POWDER-FREE NITRILE EXAMINATION GLOVES
- K994013 — POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (100 MICROGRAMS OR LESS)
Data sourced from openFDA. This site is unofficial and independent of the FDA.