LATEX EXAMINATION GLOVES— 510(k) K922255
Substantially EquivalentBalak Rubber (Malaysia) Sdn. Bhd.
FDA 510(k) clearance K922255 for LATEX EXAMINATION GLOVES, Substantially Equivalent on 1992-10-01. Applicant: Balak Rubber (Malaysia) Sdn. Bhd.. Device class: 1.
Clearance details
- Applicant
- Balak Rubber (Malaysia) 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
- Malaysia, MG
Recent devices under product code LYY
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- 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.