Glovatex White Latex Gloves, Glovanil Blue Nitrile Gloves— 510(k) K213775
Substantially EquivalentAvecena Gloves Sdn Bhd
FDA 510(k) clearance K213775 for Glovatex White Latex Gloves, Glovanil Blue Nitrile Gloves, Substantially Equivalent on 2022-04-24. Applicant: Avecena Gloves Sdn Bhd. Device class: 1.
Clearance details
- Applicant
- Avecena Gloves 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
- Negeri Sembilan, 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
Data sourced from openFDA. This site is unofficial and independent of the FDA.