POLYMER COATED POWDER FREE LATEX EXAMINATION GLOVES— 510(k) K003904
Substantially EquivalentPurna Bina Sdn Bhd
FDA 510(k) clearance K003904 for POLYMER COATED POWDER FREE LATEX EXAMINATION GLOVES, Substantially Equivalent on 2001-01-24. Applicant: Purna Bina Sdn Bhd. Device class: 1.
Clearance details
- Applicant
- Purna Bina 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
- Kluang, Jahor, 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 Purna Bina Sdn Bhd
view all- K130450 — SURGTEX POWDERED SURGICAL GLOVE, SURGTEX POWDERFREE POLYMER COATED SURGICAL GLOVE
- K083571 — ILLUSION POWDER FREE EXAM GLOVES, NATURAL COLOR WITH VANILLA SCENT, ORANGE COLOR WITH CITRIC SCENT AND PINK COLOR
- K041004 — ILLUSION POWDER FREE-POLYMER COATED COLOR SCENTED NR LATEX EXAMINATION GLOVES (BLUE)
- K022659 — ILLUSION POWDER FREE-PLOYMER COATED COLOR SCENTED NR LATEX EXAMINATION GLOVES (BLUE)
- K994420 — POWDER FREE LATEX EXAMINATION PATIENT GLOVES
Data sourced from openFDA. This site is unofficial and independent of the FDA.