LATEX EXAM GLOVES (MFG. KOON SENG SDN BHD)— 510(k) K891728
Substantially EquivalentBaldur Systems Corp.
FDA 510(k) clearance K891728 for LATEX EXAM GLOVES (MFG. KOON SENG SDN BHD), Substantially Equivalent on 1989-05-25. Applicant: Baldur Systems Corp.. Device class: 1.
Clearance details
- Applicant
- Baldur Systems Corp.
- 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
- Hayward, CA, US
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 Baldur Systems Corp.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.