SENSTOUCH HIGH RISK LATEX EXAMINATION GLOVES, POWDER FREE, NON STERILE— 510(k) K062313
Substantially EquivalentPt Mahakarya Inti Buana
FDA 510(k) clearance K062313 for SENSTOUCH HIGH RISK LATEX EXAMINATION GLOVES, POWDER FREE, NON STERILE, Substantially Equivalent on 2006-11-30. Applicant: Pt Mahakarya Inti Buana. Device class: 1.
Clearance details
- Applicant
- Pt Mahakarya Inti Buana
- 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
- Tanjung Morawa, Sumut, ID
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 Pt Mahakarya Inti Buana
view all- K111300 — SENSTOUCH NITRILE EXAMINATION GLOVES, POWDER FREE, NON STERILE (GREEN, ORANGE, VIOLET AND WHITE)
- K090464 — BLACK NITRILE EXAMINATION GLOVES, POWDER FREE, NON STERILE
- K063581 — SENSTOUCH HIGH RISK BLUE LATEX EXAMINATION GLOVES, POWDERED, NON STERILE
- K061233 — SENSTOUCH POWDER FREE EXAMINATION GLOVES, NON STERILE
- K053305 — SENSTOUCH POWDERED EXAMINATION GLOVES, NON STERILE
Data sourced from openFDA. This site is unofficial and independent of the FDA.