GLOVETEX, LATEX EXAMINATION GLOVES, POWDERED NON-STERILE.(PROTEIN CONTENT LABELING)— 510(k) K994426
Substantially EquivalentPt. Wrp Buana Multicorpora
FDA 510(k) clearance K994426 for GLOVETEX, LATEX EXAMINATION GLOVES, POWDERED NON-STERILE.(PROTEIN CONTENT LABELING), Substantially Equivalent on 2000-05-23. Applicant: Pt. Wrp Buana Multicorpora. Device class: 1.
Clearance details
- Applicant
- Pt. Wrp Buana Multicorpora
- 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
- Medan-Labuhan, 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. Wrp Buana Multicorpora
view all- K032010 — GLOVETEX POWDER FREE NITRILE EXAMINATION GLOVES, BLUE, NON-STERILE
- K032011 — GLOVETEX POWDER FREE WHITE NITRILE EXAMINATION GLOVES, NON-STERILE
- K032007 — GLOVETEX POWDER FREE LATEX EXAMINATION GLOVES, BLUE, NON-STERILE CONTAINS 50 MCGIN OR LESS OF TOTAL WATER EXTRACTABLE PR
- K030273 — GLOVETEX LATEX EXAMINATION GLOVES, POWDERED, BLUE, NON STERILE
- K022343 — GLOVETEX POWDER FREE LATEX EXAMINATION GLOVES, NON STERILE (PROTEIN CONTENT LABELING CLAIM 50UG/G OR LESS)
Data sourced from openFDA. This site is unofficial and independent of the FDA.