POWDER FREE LATEX EXAMINATION GLOVES, NON-STERILE— 510(k) K081488
Substantially EquivalentPt. Maja Agung Latexindo
FDA 510(k) clearance K081488 for POWDER FREE LATEX EXAMINATION GLOVES, NON-STERILE, Substantially Equivalent on 2008-08-28. Applicant: Pt. Maja Agung Latexindo. Device class: 1.
Clearance details
- Applicant
- Pt. Maja Agung Latexindo
- 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
- Chino, CA, US
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 Pt. Maja Agung Latexindo
view all- K212408 — Powder Free Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs Use and Simulated Gastric Acid)
- K161099 — Powder Free Nitrile Examination Gloves, Black
- K062709 — POWDER FREE LATEX EXAMINATION GLOVES, BLACK
- K020040 — LATEX PRE-POWDERED EXAMINATION GLOVES WITH PROTEIN CLAIM
- K013996 — LATEX POWDERFREE STERILE EXAMINATION GLOVES, MODELS-EXTRA SMALL, SMALL, MEDIUM, LARGE, EXTRA LARGE
Data sourced from openFDA. This site is unofficial and independent of the FDA.