POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (100 MICROGRAMS OR LESS)— 510(k) K994013
Substantially EquivalentGlovco (M) Sdn. Bhd.
FDA 510(k) clearance K994013 for POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (100 MICROGRAMS OR LESS), Substantially Equivalent on 2000-01-20. 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
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- 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
- K013828 — GLOVCO EBONY
- K021730 — GLOVCO BRAND POWDER-FREE NITRILE EXAMINATION GLOVES (PURPLE)
- K021308 — GLOVCO POWDER-FREE NITRILE EXAMINATION GLOVES
Data sourced from openFDA. This site is unofficial and independent of the FDA.