PATIENT EXAMINATION GLOVES (LATEX)— 510(k) K892610
Substantially EquivalentPt. Indolex Karya Prakarsa
FDA 510(k) clearance K892610 for PATIENT EXAMINATION GLOVES (LATEX), Substantially Equivalent on 1989-09-18. Applicant: Pt. Indolex Karya Prakarsa. Device class: 1.
Clearance details
- Applicant
- Pt. Indolex Karya Prakarsa
- 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
- Jakarta 14450, Indonesia, ID
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.