SINGLE USE, DISPOSABLE, BLUE COLOR, POWDER FREE LATEX PATIENT EXAMINATION GLOVE— 510(k) K072802
Substantially EquivalentUltrawin Sdn Bhd
FDA 510(k) clearance K072802 for SINGLE USE, DISPOSABLE, BLUE COLOR, POWDER FREE LATEX PATIENT EXAMINATION GLOVE, Substantially Equivalent on 2008-02-29. Applicant: Ultrawin Sdn Bhd. Device class: 1.
Clearance details
- Applicant
- Ultrawin 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
- Teluk Intan, 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 Ultrawin Sdn Bhd
view allData sourced from openFDA. This site is unofficial and independent of the FDA.